Relevant State Law Requirements

August 2020

Maryland law incorporates the Federal Regulations governing human subjects research and expands their application to all research, not only federally funded research. In addition, Maryland law provides access to the minutes of IRB meetings and grants power to the Attorney General to enforce the law.

Maryland law does not separately address criteria or standards for the participation of persons in research. Rather, Maryland law addresses criteria and standards for the involvement of persons in clinical care. Therefore, in Maryland, State law addressing clinical care is used as the basis for approving participation of persons in research.

This web posting is intended to be a resource to Johns Hopkins investigators. The following list of Maryland Statutes encompasses the majority of the laws that govern research in Maryland. This listing is not exhaustive and will be expanded as changes and additions are determined necessary. The JHM IRB Regulatory Team is available to discuss any questions regarding these laws.

DC and Florida Laws found here:

Legal Requirements in the District of Columbia pertaining to research with human participants
Legal Requirements in the State of Florida pertaining to research with human participants

Research

1. Health-General §13-2001: Human Subject Research: Definitions.
2. Health-General §13-2002: Human Subjects Research: Construction with federal regulations.
3. Health-General §13-2003: Human Subjects Research: Institution Review Board Meeting Minutes.
4. Health-General §13-2004: Human Subjects Research: Actions by Attorney General.
5. Health-General §18-201: Disease Prevention: Duty of Physician to Report Contagious Diseases.
6. Health-General §18-201.1: Disease Prevention: Duty of Physician to Report HIV/AIDS.
7. Health-General §18-205: Disease Prevention: Duty of Laboratory to Report Infectious or Contagious Diseases.

Clinical Practice

Guardianship and Decision-making

1. Family Law §5-203: Natural guardianship; powers and duties of parents; award of custody to parent.
2. Family Law §9.5-101: Definition of “child”.
3. Health General §5-605: Authorization of Surrogate.
4. Health General §20-102: Consent to Medical Treatment by Minor.

Abuse

5. Family Law §5-704: Reports of suspected abuse or neglect; health practitioners, police officers, educators, and human service workers.
6. Family Law §5-705: Child Abuse and Neglect: Reports of suspected abuse or neglect; other persons
7. Family Law §5-705.1: Child Abuse and Neglect: Abuse or neglect occurring outside the State.
8. Family Law §14-302: Adult Protective Services: Mandatory Reporting.

Privacy and Confidentiality

Organ and Tissue Donation

Drugs

1. Health - General § 21-223: Approved Applications Required to Sell, Give Away, or Deliver New Drugs.

Research

Health-General §13-2001: Definitions

In general

(a) In this subtitle the following words have the meanings indicated.

Federal regulations on the protection of human subjects

(b) “Federal regulations on the protection of human subjects” means:

(1) Title 45, Part 46 of the Code of Federal Regulations, and any subsequent revision of those regulations; and
(2) With respect to research that is subject to the jurisdiction of the federal Food and Drug Administration, Title 21, Parts 50 and 56 of the Code of Federal Regulations, and any subsequent revision of those regulations.

Human subject

Institutional review board

(d) “Institutional review board” has the meaning stated in the federal regulations on the protection of human subjects.

Research

(e) “Research” has the meaning stated in the federal regulations on the protection of human subjects.

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Health-General §13-2002: Construction with federal regulations.

In general

(a) A person may not conduct research using a human subject unless the person conducts the research in accordance with the federal regulations on the protection of human subjects.

Research using human subjects

(b) Notwithstanding any provision in the federal regulations on the protection of human subjects that limits the applicability of the federal regulations to certain research, subsection (a) of this section applies to all research using a human subject.

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Health-General §13-2003: Minutes of institutional review boards.

Request for minutes

(a) An institutional review board shall make the final minutes of a meeting available for inspection within 30 days of receipt of a request for the minutes from any person.

Confidential or privileged information

(b) Prior to making the minutes of a meeting available for inspection under subsection (a) of this section, an institutional review board may redact confidential or privileged information.

Public records

(c) The minutes of a meeting of an institutional review board are not public records under Title 4 of the General Provisions Article.

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Health-General §13-2004: Actions by Attorney General

In general

(a) The Office of the Attorney General may seek appropriate injunctive or other relief to prevent the conduct of human subject research in violation of the federal regulations on the protection of human subjects or this subtitle.

Restrictions

(b) In exercising the authority granted under subsection (a) of this section, the Office of the Attorney General may not:

(1) Duplicate the investigatory, compliance, or enforcement action undertaken by an agency of the federal government; or
(2) Bring an action under subsection (a) of this section if an agency of the federal government has determined that an investigation is not warranted.

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Health-General §18-201: Duty of physician to report contagious diseases.

In general

(a) A physician with reason to suspect that a patient under the physician's care has a condition or an infectious or contagious disease, except human immunodeficiency virus or acquired immunodeficiency syndrome, that endangers public health and that has been designated by the Secretary as reportable shall submit immediately a report to the health officer for the county where the physician cares for that patient.

Content of report

(b) The report shall:

(1) Contain the information and be in a format specified or approved by the Secretary; and

(2) Be transmitted as directed by the Secretary.

Confidentiality

(c) (1) Except as provided in paragraphs (2) through (5) of this subsection, all reports and all information collected in connection with a report from a health care provider, the subject of the report, or other individuals who might be affected by the condition or disease in the report are:

(i) Confidential;
(ii) Not medical records under Title 4, Subtitle 3 of this article;
(iii) Not open to public inspection; and
(iv) Not discoverable or admissible in evidence in any civil or criminal matter except in accordance with a court order sealing the court record.

(2) This subsection does not apply to reports, information, and records otherwise available to the public or required to be publicly disclosed.

(3) The Secretary may prepare and disseminate non-individually identifiable information about one or more cases of a condition or disease based on any report received under this section, for any purpose consistent with the Secretary's lawful duties as authorized by an act of the Maryland General Assembly.

(4) This subsection does not apply to or restrict the use or publication of any statistics, information, or other material that summarizes or refers to confidential records in the aggregate, without disclosing the identity of any individual who is the subject of the confidential record.

(5) This subsection does not apply to a disclosure by the Secretary to another governmental agency performing its lawful duties as authorized by an act of the Maryland General Assembly or the United States Congress where the Secretary determines that:

(i) The agency to whom the information is disclosed will maintain the confidentiality of the disclosure; and
(ii) The disclosure is necessary to protect the public health or to prevent the spread of an infectious or contagious disease.

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Health-General §18-201.1: Duty of physician to report HIV/AIDS.

In general

(a) A physician who has diagnosed a patient under the physician's care with human immunodeficiency virus infection or acquired immunodeficiency syndrome according to the current definition published in the morbidity and mortality weekly report by the Centers for Disease Control and Prevention of the Department of Health and Human Services shall submit immediately a report to the health officer for the county where the physician cares for that patient.

Contents of report

(b) The report shall:

(1) Be on the form that the Secretary provides;
(2) Identify the disease;
(3) State the name, age, race, sex, and residence address of the patient; and
(4) Be signed by the physician.

Report deadline

(c) (1) A physician shall submit a report as described in subsection (b) of this section to the Secretary within 48 hours of the birth of an infant whose mother has tested positive for the human immunodeficiency virus.

(2) If a newborn infant does not become HIV positive after 18 months from the date that the report required in paragraph (1) of this subsection was submitted, the Secretary shall have the newborn infant's name removed from the HIV registry.

Confidentiality

(d) (1) All physician reports required under this section are:

(i) Confidential and subject to Title 4, Subtitle 1 of this article; and
(ii) Not medical records under Title 4, Subtitle 3 of this article, but are subject to the confidentiality requirements of Title 4, Subtitle 1 of this article

(2) The reports and any proceedings, records, or files relating to the reports required under this section are not discoverable and are not admissible in evidence in any civil action.

(3) This subsection does not apply to a disclosure by the Secretary to another governmental agency performing its lawful duties pursuant to State or federal law where the Secretary determines the agency to whom the information is disclosed will maintain the confidentiality of the disclosure.

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Health-General §18-205: Duty of laboratory to report infectious or contagious disease.

Clinical material defined

(a) In this section, “clinical material” means:

(1) An organism isolated from a clinical specimen;

(2) Material derived or prepared from a clinical specimen in which evidence of a communicable disease has been identified or detected; or

(3) If the organism or material described in subparagraph (i) or (ii) of this paragraph is not available, material from an individual that has already been obtained by the medical laboratory, in the following order of preference:

(i) A patient specimen;

(ii) Microbial genetic material; or

(iii) Other laboratory material.

In general

(b) (1) Except for the director of the State's public health laboratory system, the director of a medical laboratory located in this State shall submit a report to the health officer for the county where the laboratory is located after an examination of a human specimen shows evidence of any infectious or contagious disease or condition that has been designated by the Secretary as reportable.

(2) The director of the State's public health laboratory system shall submit a report to the Secretary if an examination of a human specimen shows evidence of any infectious or contagious disease or condition that has been designated by the Secretary as reportable.

(3) The director of a medical laboratory located outside of this State that performs a medical laboratory test on a human specimen acquired from a person in this State shall submit a report to the Secretary after an examination of that specimen shows evidence of any infectious or contagious disease or condition that has been designated by the Secretary as reportable.

(4) A director of a medical laboratory shall submit clinical material to the Secretary as directed by the Secretary.

Multiple reports

(c) (1) When more than 1 specimen is taken from a patient during 1 disease episode, the director of the medical laboratory need not report every test result of a specimen that shows evidence of the same disease in that patient if:

(i) At least 1 positive test result is reported; and
(ii) The health officer has approved the reporting of less than all test results.

(2) The director of the medical laboratory need not report vibriosis, noncholera, if the disease is found in a specimen obtained from the patient's teeth, gingival tissues, or oral mucosa.

Content of report

(d) The report shall:

(1) Contain the information and be in a format specified or approved by the Secretary; and

(2) Be transmitted as directed by the Secretary.

Other reporting duties

(e) This section does not relieve a person of the duty to report under § 18-201, § 18-201.1, § 18-202, or § 18-202.1 of this subtitle.

Notification of Secretary

(f) (1) A health officer shall inform the Secretary of each laboratory examination report received under subsection (b)(1) of this section.

(2) The Secretary shall inform the health officer of the jurisdiction where the patient resides of a laboratory examination report received under this section from a medical laboratory located outside this State.

Communications related to report

(g) The Secretary, a health officer, or an agent of the Secretary or health officer may discuss a laboratory report with the attending physician or another health care provider caring for a patient, but, if the physician or another health care provider caring for a patient is not reasonably available, may communicate with a patient directly in a manner prescribed by the Secretary.

Confidentiality

(h) (1) Except as provided in paragraphs (2) through (5) of this subsection, all reports and all information collected in connection with a report from a health care provider, the subject of the report, or other individuals who might be affected by the condition or disease in the report are:

            (i) Confidential;
            (ii) Not medical records under Title 4, Subtitle 3 of this article;
            (iii) Not open to public inspection; and
(iv) Not discoverable or admissible in evidence in any civil or criminal matter except in accordance with a court order sealing the court record.

(2) This subsection does not apply to reports, information, and records otherwise available to the public or required to be publicly disclosed.

(3) The Secretary may prepare and disseminate nonindividually identifiable information about one or more cases of a condition or a disease based on any report made under this section, for any purpose consistent with the Secretary's lawful duties as authorized by an act of the Maryland General Assembly.

(4) This subsection does not apply to a disclosure by the Secretary to another governmental agency performing its lawful duties as authorized by an act of the Maryland General Assembly or the United States Congress where the Secretary determines that:

(5) This subsection does not apply to or restrict the use or publication of any statistics, information, or other material that summarizes or refers to confidential records in the aggregate, without disclosing the identity of any individual who is the subject of the confidential record.

Inspections

(i) To assure compliance with this section, the Secretary, a health officer, or an agent of the Secretary or health officer may inspect pertinent laboratory records.

Regulations

(j) The Secretary shall adopt regulations that designate the diseases or conditions that are reportable by a director of a medical laboratory under this section.

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Clinical Practice

Guardianship and Decision-making

Family Law §5-203: Natural guardianship; powers and duties of parents; award of custody to parent.

Natural guardianship

(a) (1) The parents are the joint natural guardians of their minor child.

(2) A parent is the sole natural guardian of the minor child if the other parent:

            (i) dies;
            (ii) abandons the family; or
            (iii) is incapable of acting as a parent.

Powers and duties of parents

(b) The parents of a minor child, as defined in § 1-103 of the General Provisions Article:

(1) are jointly and severally responsible for the child's support, care, nurture, welfare, and education; and

(2) have the same powers and duties in relation to the child.

Duties of parents of minor parents

(c) If one or both parents of a minor child is an unemancipated minor, the parents of that minor parent are jointly and severally responsible for any child support for a grandchild that is a recipient of temporary cash assistance to the extent that the minor parent has insufficient financial resources to fulfill the child support responsibility of the minor parent.

Award of custody to parent

(d) (1) If the parents live apart, a court may award custody of a minor child to either parent or joint custody to both parents.

(2) Neither parent is presumed to have any right to custody that is superior to the right of the other parent.

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Family Law §9.5-101: Definition of “Child”.

“Child” means an individual under the age of 18 years.

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Health General §5-605: Authorization of Surrogate.

Persons eligible to make health care decisions

(a)(1)

            (i) In this subsection the following words have the meanings indicated.
            (ii) “Person eligible for relief” has the meaning stated in § 4-501 of the Family Law Article.
            (iii) “Unavailable” means:

                        1. After reasonable inquiry, a health care provider is unaware of the existence of a health care agent or surrogate decision maker;
                        2. After reasonable inquiry, a health care provider cannot ascertain the whereabouts of a health care agent or surrogate decision maker;
                        3. A health care agent or surrogate decision maker has not responded in a timely manner, taking into account the health care needs of the individual, to a written or oral message from a health care provider;
                        4. A health care agent or surrogate decision maker is incapacitated; or
                        5. A health care agent or surrogate decision maker is unwilling to make decisions concerning health care for the individual.

(2) Subject to paragraph (4) of this subsection, the following individuals or groups, in the specified order of priority, may make decisions about health care for a person who has been certified to be incapable of making an informed decision and who has not appointed a health care agent in accordance with this subtitle or whose health care agent is unavailable. Individuals in a particular class may be consulted to make a decision only if all individuals in the next higher class are unavailable:

            (i) A guardian for the patient, if one has been appointed;
            (ii) The patient's spouse or domestic partner;
            (iii) An adult child of the patient;
            (iv) A parent of the patient;
            (v) An adult brother or sister of the patient; or
            (vi) A friend or other relative of the patient who meets the requirements of paragraph (3) of this subsection.

(3) A friend or other relative may make decisions about health care for a patient under paragraph (2) of this subsection if the person:

            (i) Is a competent individual; and
            (ii) Presents an affidavit to the attending physician stating:
                        1. That the person is a relative or close friend of the patient; and
                        2. Specific facts and circumstances demonstrating that the person has maintained regular contact with the patient sufficient to be familiar with the patient's activities, health, and personal beliefs.

(4) An individual may not make decisions about health care for a patient under paragraph (2) of this subsection if:

(i) The individual is the subject of an interim, temporary, or final protective order and the patient is a person eligible for relief under the order; or
(ii) The individual is the spouse of the patient and:

1. The individual and patient have executed a separation agreement; or
2. The individual or patient has filed an application for divorce.

(5) The attending physician shall include the affidavit presented under paragraph (3) of this subsection in the patient's medical record.

(6) A person who obtains new information that would prohibit an individual from making health care decisions for a patient under paragraph (4) of this subsection shall provide the information to any health care provider or health care facility providing services to the patient.

Disagreement of health care decisions

(b) (1) If persons with equal decision making priority under subsection (a) of this section disagree about a health care decision, and a person who is incapable of making an informed decision is receiving care in a hospital or related institution, the attending physician or an individual specified in subsection (a) of this section shall refer the case to the institution's patient care advisory committee, and may act in accordance with the recommendation of the committee or transfer the patient in accordance with the provisions of § 5-613 of this subtitle. A physician who acts in accordance with the recommendation of the committee is not subject to liability for any claim based on lack of consent or authorization for the action.

(2) If a person who is incapable of making an informed decision is not in a hospital or related institution, a physician may not withhold or withdraw life-sustaining procedures if there is not agreement among all the persons in the same class.

Wishes of patient

(c) (1) Any person authorized to make health care decisions for another under this section shall base those decisions on the wishes of the patient and, if the wishes of the patient are unknown or unclear, on the patient's best interest.

(2) In determining the wishes of the patient, a surrogate shall consider the patient's:

            (i) Current diagnosis and prognosis with and without the treatment at issue;
            (ii) Expressed preferences regarding the provision of, or the withholding or withdrawal of, the specific treatment at issue or of similar treatments;
            (iii) Relevant religious and moral beliefs and personal values;
            (iv) Behavior, attitudes, and past conduct with respect to the treatment at issue and medical treatment generally;
            (v) Reactions to the provision of, or the withholding or withdrawal of, a similar treatment for another individual; and
            (vi) Expressed concerns about the effect on the family or intimate friends of the patient if a treatment were provided, withheld, or withdrawn.

(3) The decision of a surrogate regarding whether life-sustaining procedures should be provided, withheld, or withdrawn shall not be based, in whole or in part, on either a patient's preexisting, long-term mental or physical disability, or a patient's economic disadvantage.

(4) A surrogate shall inform the patient, to the extent possible, of the proposed procedure and the fact that someone else is authorized to make a decision regarding that procedure.

Unauthorized health care decisions

(d) A surrogate may not authorize:

(1) Sterilization; or

(2) Treatment for a mental disorder.

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Health-General §20-102: Consent to Medical treatment by minor.

Capacity to consent

(a) A minor has the same capacity as an adult to consent to medical or dental treatment if the minor:

(1) Is married;

(2) Is the parent of a child; or

(3)(i) Is living separate and apart from the minor's parent, parents, or guardian, whether with or without consent of the minor's parent, parents, or guardian; and

(ii) Is self-supporting, regardless of the source of the minor's income.

Urgency of treatment

(b) A minor has the same capacity as an adult to consent to medical treatment if, in the judgment of the attending physician, the life or health of the minor would be affected adversely by delaying treatment to obtain the consent of another individual.

Substance abuse, sexual health treatment

(1) Treatment for or advice about drug abuse;

(2) Treatment for or advice about alcoholism;

(3) Treatment for or advice about venereal disease;

(4) Treatment for or advice about pregnancy;

(5) Treatment for or advice about contraception other than sterilization;

(6) Physical examination and treatment of injuries from an alleged rape or sexual offense;

(7) Physical examination to obtain evidence of an alleged rape or sexual offense;

(8) Initial medical screening and physical examination on and after admission of the minor into a detention center; and

(9) Treatment for the prevention of human immunodeficiency virus (HIV).

Refusal of treatment

(c-1) The capacity of a minor to consent to treatment for drug abuse or alcoholism under subsection (c)(1) or (2) of this section does not include the capacity to refuse treatment for drug abuse or alcoholism in an inpatient or intensive outpatient alcohol or drug abuse treatment program certified under Title 8 of this article for which a parent or guardian has given consent.

Psychological treatment

(d) A minor has the same capacity as an adult to consent to psychological treatment as specified under subsection (c)(1) and (2) of this section if, in the judgment of the attending physician or a psychologist, the life or health of the minor would be affected adversely by delaying treatment to obtain the consent of another individual.

Civil liability

(e) A licensed health care practitioner who treats a minor is not liable for civil damages or subject to any criminal or disciplinary penalty solely because the minor did not have capacity to consent under this section.

Parental notification

(f) Without the consent of or over the express objection of a minor, a licensed health care practitioner may, but need not, give a parent, guardian, or custodian of the minor or the spouse of the parent information about treatment needed by the minor or provided to the minor under this section, except information about an abortion.

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Abuse

Family Law §5-704: Reports of suspected abuse or neglect; health practitioners, police officers, educators, and human service workers.

Persons required to notify authorities and report suspected instances of abuse or neglect

(a) Notwithstanding any other provision of law, including any law on privileged communications, each health practitioner, police officer, educator, or human service worker, acting in a professional capacity in this State:

(1) who has reason to believe that a child has been subjected to abuse or neglect, shall notify the local department or the appropriate law enforcement agency; and

(2) if acting as a staff member of a hospital, public health agency, child care institution, juvenile detention center, school, or similar institution, shall immediately notify and give all information required by this section to the head of the institution or the designee of the head.

Oral and written reports

(b) (1) An individual who notifies the appropriate authorities under subsection (a) of this section shall make:

(i) an oral report, by telephone or direct communication, as soon as possible to the local department or appropriate law enforcement agency; and
(ii) a written report:

1. to the local department not later than 48 hours after the contact, examination, attention, or treatment that caused the individual to believe that the child had been subjected to abuse or neglect; and
2. with a copy to the local State's Attorney.

(2)(i) An agency to which an oral report of suspected abuse or neglect is made under paragraph (1) of this subsection shall immediately notify the other agency.

(ii) This paragraph does not prohibit a local department and an appropriate law enforcement agency from agreeing to cooperative arrangements.

Contents of report

(c) Insofar as is reasonably possible, an individual who makes a report under this section shall include in the report the following information:

(1) the name, age, and home address of the child;

(2) the name and home address of the child's parent or other person who is responsible for the child's care;

(3) the whereabouts of the child;

(4) the nature and extent of the abuse or neglect of the child, including any evidence or information available to the reporter concerning possible previous instances of abuse or neglect; and

(5) any other information that would help to determine:

(i) the cause of the suspected abuse or neglect; and
(ii) the identity of any individual responsible for the abuse or neglect.

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Family Law §5-705: Reports of suspected abuse or neglect; other persons.

Persons required to notify authorities and report suspected instances of abuse or neglect; exceptions

(a) (1) Except as provided in paragraphs (2) and (3) of this subsection, notwithstanding any other provision of law, including a law on privileged communications, a person in this State other than a health practitioner, police officer, or educator or human service worker who has reason to believe that a child has been subjected to abuse or neglect shall notify the local department or the appropriate law enforcement agency.

(2) A person is not required to provide notice under paragraph (1) of this subsection:

            (i) in violation of the privilege described under § 9-108 of the Courts Article;
            (ii) if the notice would disclose matter communicated in confidence by a client to the client's attorney or other information relating to the representation of the client; or
            (iii) in violation of any constitutional right to assistance of counsel.

(3) A minister of the gospel, clergyman, or priest of an established church of any denomination is not required to provide notice under paragraph (1) of this subsection if the notice would disclose matter in relation to any communication described in § 9-111 of the Courts Article and:

(i) the communication was made to the minister, clergyman, or priest in a professional character in the course of discipline enjoined by the church to which the minister, clergyman, or priest belongs; and
(ii) the minister, clergyman, or priest is bound to maintain the confidentiality of that communication under canon law, church doctrine, or practice.

Agency to notify the other agency

(b) (1) An agency to which a report of suspected abuse or neglect is made under subsection (a) of this section shall immediately notify the other agency.

(2) This subsection does not prohibit a local department and an appropriate law enforcement agency from agreeing to cooperative arrangements.

Oral or written report

Contents of report

(d) (1) To the extent possible, a report made under subsection (a) of this section shall include the information required by § 5-704(c) of this subtitle.

(2) A report made under subsection (a) of this section shall be regarded as a report within the provisions of this subtitle, whether or not the report contains all of the information required by § 5-704(c) of this subtitle.

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Family Law §5-705.1: Abuse or neglect occurring outside the State.

“Local department” defined

(a) In this section, “local department” means a department of social services for a county in this State.

Provisions of this subtitle apply to reporting suspected abuse or neglect occurring outside of this State

(b) The following provisions of this subtitle shall apply to the reporting of suspected abuse or neglect under this section:

(1) except as provided in subsection (a) of this section, the definitions set forth in § 5-701 of this subtitle;

(2) the provisions relating to the confidentiality of reports specified in § 5-707(a)(1) and (2) of this subtitle; and

(3) the provisions relating to immunity from civil liability or criminal penalty specified in § 5-708 of this subtitle.

Persons required to report suspected abuse or neglect occurring outside of this State to local department

(c) (1) If suspected abuse or neglect is alleged to have occurred outside of this State and the victim is currently a child who lives outside of this State, a person who would be required to report suspected abuse or neglect under the provisions of § 5-704 or § 5-705 of this subtitle shall report the suspected abuse or neglect to any local department in accordance with paragraph (2) of this subsection.

(2) A person described in § 5-704 of this subtitle shall make:

(i) an oral report, by telephone or direct communication, as soon as possible; and
(ii) a written report not later than 48 hours after the contact, examination, attention, or treatment that caused the person to believe that the child had been subjected to abuse or neglect.

(3) A person described in § 5-705 of this subtitle shall make an oral or a written report.

(4) To the extent possible, a report under this subsection shall include the information specified in § 5-704(c) of this subtitle.

Local department shall forward report to appropriate agency

(d) Promptly after receiving a report of suspected abuse or neglect under this section, the local department shall forward the report to the appropriate agency outside of this State that is authorized to receive and investigate reports of suspected abuse or neglect.

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Family Law §14-302: Mandatory reporting.

Persons required to report

(a) (1) Except as provided in paragraph (2) of this subsection, notwithstanding any law on privileged communications, each health practitioner, police officer, or human service worker who contacts, examines, attends, or treats an alleged vulnerable adult, and who has reason to believe that the alleged vulnerable adult has been subjected to abuse, neglect, self-neglect, or exploitation shall:

(i) notify the local department; and
(ii) if acting as a staff member of a hospital or public health agency, immediately notify and give all the information required by this section to the head of the institution or the designee of the head.

(2) An ombudsman, as defined in § 10-901 of the Human Services Article, shall comply with 42 U.S.C. § 3058g(d)(2) and may not disclose the identity of a resident or complainant except as authorized under 42 U.S.C. § 3058g(d)(2).

Means of reporting

(b) An individual who is required to make a report under subsection (a) of this section shall make the report by telephone, direct communication, or in writing to the local department as soon as possible.

Any individual may file report

(c) Any individual other than a health practitioner, human service worker, or police officer who has reason to believe that an alleged vulnerable adult has been subjected to abuse, neglect, self-neglect, or exploitation may file with the local department an oral or written report of the suspected abuse, neglect, self-neglect, or exploitation.

Contents of report

(d) Insofar as is reasonably possible, an individual who makes a report under this section shall include in the report the following information:

(1) the name, age, and home address of the alleged vulnerable adult;

(2) the name and home address of the person responsible for the care of the alleged vulnerable adult;

(3) the whereabouts of the alleged vulnerable adult;

(4) the nature of the alleged vulnerable adult's incapacity;

(5) the nature and extent of the abuse, neglect, self-neglect, or exploitation of the alleged vulnerable adult, including evidence or information available to the reporter concerning previous injury possibly resulting from abuse, neglect, self-neglect, or exploitation; and

(6) any other information that would help to determine:

(i) the cause of the suspected abuse, neglect, self-neglect, or exploitation; and
(ii) the identity of any individual responsible for the abuse, neglect, self-neglect, or exploitation.

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Privacy and Confidentiality

Health General §4-301: Definitions.

In general

(a) In this subtitle the following words have the meanings indicated.

Common ownership

(b) “Common ownership” means ownership of a health care entity:

(1) By two or more health care providers;

(2) By two or more health care providers employed by a mutual employer for a wage, salary, fee, or payment to perform work for the employer;

(3) By health care organizations operating as an organized health care arrangement, as defined in 45 C.F.R. § 160.103;

(4) By a health care entity or health care entities that possess an ownership or equity interest of 5% or more in another health care entity; or

(5) By affiliated providers operating under the same trade name.

Directory information

(c) “Directory information” means information concerning the presence and general health condition of a patient who has been admitted to a health care facility or who is currently receiving emergency health care in a health care facility.

Disclose or disclosure

(d) “Disclose” or “disclosure” means the transmission or communication of information in a medical record, including an acknowledgment that a medical record on a particular patient or recipient exists.

Emergency

(e) “Emergency” means a situation when, in the professional opinion of the health care provider, a clear and significant risk of death or imminent serious injury or harm to a patient or recipient exists.

General health condition

(f) “General health condition” means the health status of a patient described in terms of “critical”, “poor”, “fair”, “good”, “excellent”, or terms denoting similar conditions.

Health care

(g) “Health care” means any care, treatment, or procedure by a health care provider:

(1) To diagnose, evaluate, rehabilitate, manage, treat, or maintain the physical or mental condition of a patient or recipient; or

(2) That affects the structure or any function of the human body.

Health care provider

(h) (1) “Health care provider” means:

(i) A person who is licensed, certified, or otherwise authorized under the Health Occupations Article or § 13-516 of the Education Article to provide health care in the ordinary course of business or practice of a profession or in an approved education or training program; or
(ii) A facility where health care is provided to patients or recipients, including a facility as defined in § 10-101(g) of this article, a hospital as defined in § 19-301 of this article, a related institution as defined in § 19-301 of this article, a health maintenance organization as defined in § 19-701(g) of this article, an outpatient clinic, and a medical laboratory.

(2) “Health care provider” includes the agents, employees, officers, and directors of a facility and the agents and employees of a health care provider.

Health information exchange

(i) (1) “Health information exchange” means an entity that provides or governs organizational and technical processes for the maintenance, transmittal, access, or disclosure of electronic health care information between or among health care providers or entities through an interoperable system.

(2) “Health information exchange” does not include:

(i) An entity composed of health care providers under common ownership; or
(ii) If the organizational and technical processes it provides or governs are transactions, as defined in 45 C.F.R. § 160.103:

                        1. A carrier, as defined in § 15-1301 of the Insurance Article;
                        2. A carrier's business associate, as defined in 45 C.F.R. § 160.103; or
                        3. An administrator, as defined in § 8-301 of the Insurance Article.

Medical record

(j) (1) “Medical record” means any oral, written, or other transmission in any form or medium of information that:

            (i) Is entered in the record of a patient or recipient;
            (ii) Identifies or can readily be associated with the identity of a patient or recipient; and
            (iii) Relates to the health care of the patient or recipient.

(2) “Medical record” includes any:

            (i) Documentation of disclosures of a medical record to any person who is not an employee, agent, or consultant of the health care provider;
            (ii) File or record maintained under § 12-403(c)(13) of the Health Occupations Article by a pharmacy of a prescription order for drugs, medicines, or devices that identifies or may be readily associated with the identity of a patient;
            (iii) Documentation of an examination of a patient regardless of who:

1. Requested the examination; or
2. Is making payment for the examination; and

(iv) File or record received from another health care provider that:

1. Relates to the health care of a patient or recipient received from that health care provider; and
2. Identifies or can readily be associated with the identity of the patient or recipient.

Mental health services

(k) (1) “Mental health services” means health care rendered to a recipient primarily in connection with the diagnosis, evaluation, treatment, case management, or rehabilitation of any mental disorder.

(2) For acute general hospital services, mental health services are considered to be the primarily rendered service only if service is provided pursuant to Title 10, Subtitle 6 of this article or Title 3 of the Criminal Procedure Article.

Patient

(l) “Patient” means a person who receives health care and on whom a medical record is maintained.

Person in interest

(m) “Person in interest” means:

(1) An adult on whom a health care provider maintains a medical record;

(2) A person authorized to consent to health care for an adult consistent with the authority granted;

(3) A duly appointed personal representative of a deceased person;

(4)(i) A minor, if the medical record concerns treatment to which the minor has the right to consent and has consented under Title 20, Subtitle 1 of this article; or

(ii) A parent, guardian, custodian, or a representative of the minor designated by a court, in the discretion of the attending physician who provided the treatment to the minor, as provided in § 20-102 or § 20-104 of this article;

(5) If item (4) of this subsection does not apply to a minor:

(i) A parent of the minor, except if the parent's authority to consent to health care for the minor has been specifically limited by a court order or a valid separation agreement entered into by the parents of the minor; or
(ii) A person authorized to consent to health care for the minor consistent with the authority granted; or

(6) An attorney appointed in writing by a person listed in item (1), (2), (3), (4), or (5) of this subsection.

Primary provider of mental health services

(n) “Primary provider of mental health services” means the designated mental health services provider who:

(1) Has primary responsibility for the development of the mental health treatment plan for the recipient; and

(2) Is actively involved in providing that treatment.

Protected health information

(o) “Protected health information” means all individually identifiable health information held or transmitted by a covered entity or its business associate protected under the U.S. Department of Health and Human Services Privacy Rule.

Recipient

(p) “Recipient” means a person who has applied for, for whom an application has been submitted, or who has received mental health services.

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Health General §4-302: Confidentiality of medical records; disclosure.

In general

(a) A health care provider shall:

(1) Keep the medical record of a patient or recipient confidential; and

(2) Disclose the medical record only:

(i) As provided by this subtitle; or
(ii) As otherwise provided by law.

Application of subtitle

(b) The provisions of this subtitle do not apply to information:

(1) Not kept in the medical record of a patient or recipient that is related to the administration of a health care facility, including:

            (i) Risk management;
            (ii) Quality assurance; and
            (iii) Any activities of a medical or dental review committee that are confidential under the provisions of § 1-401 and Title 4, Subtitle 5 of the Health Occupations Article and any activities of a pharmacy review committee;

(2) Governed by the federal confidentiality of alcohol and drug abuse patient records regulations, 42 C.F.R. Part 2 and the provisions of § 8-601(c) of this article; or

(3) Governed by the developmental disability confidentiality provisions in §§ 7-1008 through 7-1011 of this article.

Disclosure of directory information

(c) (1) Unless the patient has restricted or prohibited the disclosure of directory information, a health care provider may disclose directory information about a patient to an individual who has asked for the patient by name.

(2) A health care provider shall:

(i) Inform a patient of the health care information that the health care provider may include in a directory and the persons to whom the health care provider may disclose the information; and
(ii) As soon as practicable, provide the patient with the opportunity to restrict or prohibit disclosure of directory information.

(3) If providing an opportunity under paragraph (2)(ii) of this subsection to restrict or prohibit the disclosure of directory information is not practicable because of the patient's incapacity or need for emergency care or treatment, a health care provider may disclose the patient's directory information if the disclosure is:

(i) Consistent with a prior expressed preference of the patient that is known to the health care provider; and
(ii) Determined to be, based on the health care provider's professional judgment, in the patient's best interest.

Redisclosure of medical record

(d) A person to whom a medical record is disclosed may not redisclose the medical record to any other person unless:

(1) The redisclosure is:

            (i) Authorized by the person in interest;
            (ii) Otherwise permitted by this subtitle;
            (iii) Permitted under § 1-202(b) or (c) of the Human Services Article; or
            (iv) Directory information; or

(2) (i) The person to whom the medical record was disclosed is a guardian ad litem who received the medical record in accordance with § 4-306(b)(12) of this subtitle;

(ii) A reasonable effort to secure a qualified protective order has been made in accordance with 42 C.F.R. § 164.512(e)(1)(v); and
(iii) The guardian ad litem determines that it is necessary to redisclose the medical record to carry out the guardian ad litem's official function to protect the best interests of a minor or a disabled or elderly individual in a criminal or juvenile delinquency court proceeding.

Disclosure of medical records

(e) (1) Except as provided in paragraph (2) of this subsection, a person may not disclose by sale, rental, or barter any medical record.

(2) This subsection shall not prohibit the transfers of medical records relating to the transfer of ownership of a health care practice or facility if the transfer is in accord with the ethical guidelines of the applicable health care profession or professions.

Reporting requirements

(f) The provisions of this subtitle may not be construed to constitute an exception to the reporting requirements of Title 5, Subtitle 7 and Title 14, Subtitle 3 of the Family Law Article.

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Health General §4-303: Authorization to disclose medical records.

In general

(a) A health care provider shall disclose a medical record on the authorization of a person in interest in accordance with this section.

Authorization requirements

(b) Except as otherwise provided in subsections (c) and (d) of this section, an authorization shall:

(1) Be in writing, dated, and signed by the person in interest;

(2) State the name of the health care provider;

(3) Identify to whom the information is to be disclosed;

(4) State the period of time that the authorization is valid, which may not exceed 1 year, except:

(i) In cases of criminal justice referrals, in which case the authorization shall be valid until 30 days following final disposition; or
(ii) In cases where the patient on whom the medical record is kept is a resident of a nursing home, in which case the authorization shall be valid until revoked, or for any time period specified in the authorization; and

(5) Apply only to a medical record developed by the health care provider unless in writing:

(i) The authorization specifies disclosure of a medical record that the health care provider has received from another provider; and
(ii) The other provider has not prohibited redisclosure.

Disclosure of medical record

(c) A health care provider shall disclose a medical record on receipt of a preauthorized form that is part of an application for insurance.

Release of relevant information

(d) A health care provider shall disclose a medical record on receipt of an authorization for the release of relevant medical information that is included with the claim application form filed with the Workers' Compensation Commission in accordance with § 9-709(a), § 9-710(b), or § 9-711(a) of the Labor and Employment Article.

Revocation of authorization

(e) (1) Except in cases of criminal justice referrals, a person in interest may revoke an authorization in writing.

(2) A revocation of an authorization becomes effective on the date of receipt by the health care provider.

(3) A disclosure made before the effective date of a revocation is not affected by the revocation.

Copies to be filed with medical record

(f) A copy of the following shall be entered in the medical record of a patient or recipient:

(1) A written authorization;

(2) Any action taken in response to an authorization; and

(3) Any revocation of an authorization.

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Health General §4-304: Medical records; copy fees.

In general

(a) (1) Except as otherwise provided in this subtitle, a health care provider shall comply within a reasonable time after a person in interest requests in writing:

(i) To receive a copy of a medical record; or
(ii) To see and copy the medical record.

(2) If a medical record relates to a psychiatric or psychological problem and the attending health care provider, with any available and feasible input from a primary provider of mental health services, believes disclosure of any portion of the medical record to be injurious to the health of a patient or recipient, the health care provider may refuse to disclose that portion of the medical record to the patient, recipient, or person in interest but, on written request, shall:

            (i) Make a summary of the undisclosed portion of the medical record available to the patient, recipient, or person in interest;
            (ii) Insert a copy of the summary in the medical record of the patient or recipient;
            (iii) Permit examination and copying of the medical record by another health care provider who is authorized to treat the patient or recipient for the same condition as the health care provider denying the request; and
            (iv) Inform the patient or recipient of the patient's or recipient's right to select another health care provider under this subsection.

Addition or corrections to medical record

(b) (1) A health care provider shall establish procedures for a person in interest to request an addition to or correction of a medical record.

(2) A person in interest may not have any information deleted from a medical record.

(3) Within a reasonable time after a person in interest requests a change in a medical record, the health care provider shall:

(i) Make the requested change; or
(ii) Provide written notice of a refusal to make the change to the person in interest.

(4) A notice of refusal shall contain:

(i) Each reason for the refusal; and
(ii) The procedures, if any, that the health care provider has established for review of the refusal.

(5) If the final determination of the health care provider is a refusal to change the medical record, the provider:

(i) Shall permit a person in interest to insert in the medical record a concise statement of the reason that the person in interest disagrees with the record; and
(ii) May insert in the medical record a statement of the reasons for the refusal.

(6) A health care provider shall give a notice of a change in a medical record or a copy of a statement of disagreement:

(i) To any individual the person in interest has designated to receive the notice or statement; and
(ii) To whom the health care provider has disclosed an inaccurate, an incomplete, or a disputed medical record within the previous 6 months.

(7) If a health care provider discloses a medical record after an addition, correction, or statement of disagreement has been made, the provider shall include with the medical record a copy of each addition, correction, or statement of disagreement.

Fees

(c) (1)(i) In this subsection, “medical record” includes a copy of a medical bill that has been requested by an individual.
(ii) The provisions of this subsection do not apply to x-rays.

(2) A health care provider may require a person in interest or any other authorized person who requests a copy of a medical record to pay for the cost of copying:

(i) For State facilities regulated by the Maryland Department of Health, as provided in § 4-206 of the General Provisions Article; or
(ii) For all other health care providers, a reasonable cost-based fee for providing the information requested.

(3)(i) Except as provided in subparagraph (iii) of this paragraph, for a copy of a medical record requested by a person in interest or any other authorized person under paragraph (2)(ii) of this subsection, a health care provider may charge a fee for copying and mailing not exceeding 76 cents for each page of the medical record.
(ii) In addition to the fee charged under subparagraph (i) of this paragraph, a hospital or a health care provider may charge:

1. Subject to the fee limitations that apply to persons in interest under 45 C.F.R. 164.524 and any guidance on those limitations issued by the U.S. Department of Health and Human Services, a preparation fee not to exceed $22.88 for medical record retrieval and preparation; and
2. The actual cost for postage and handling of the medical record.

(iii) Subject to the fee limitations that apply to persons in interest under 45 C.F.R. 164.524 and any guidance on those limitations issued by the U.S. Department of Health and Human Services, a hospital or a health care provider that uses or maintains the requested medical records in an electronic format may charge for an electronic copy of a medical record in an electronic format requested by a person in interest or any other authorized person:

                        1. A preparation fee not to exceed $22.88 for electronic format medical records retrieval and preparation;
                        2. A per-page fee of 75% of the per-page fee charged by a health care provider under subparagraph (i) of this paragraph that may not exceed $80; and
                        3. The actual cost for postage and handling of the electronic format medical records.

(4)(i) Except as provided in subparagraph (ii) of this paragraph, the fees charged under paragraph (3) of this subsection may be adjusted annually for inflation in accordance with the Consumer Price Index.
(ii) The preparation fee charged for medical record retrieval and preparation under paragraph (3)(ii)1 of this subsection and for retrieval and preparation of a medical record in an electronic format under paragraph (3)(iii)1 of this subsection may not be adjusted annually for inflation in accordance with the Consumer Price Index.

(5)(i) Except as provided in subparagraph (ii) of this paragraph, a health care provider may charge a fee, as authorized under paragraphs (3) and (4) of this subsection, for the retrieval, copying, preparation, mailing, and actual cost of postage and handling of a medical record disclosed under § 4-306 of this subtitle.
(ii) If a government unit or agency or court-appointed guardian ad litem in a criminal or juvenile delinquency court proceeding makes a request for the disclosure of a medical record under § 4-306 of this subtitle, a health care provider may not charge the government unit or agency or court-appointed guardian ad litem a fee for the retrieval, copying, preparation, mailing, and actual cost of postage and handling of the medical record.

(6) Notwithstanding any other provision of law, a health care provider may not charge a person in interest, except for an attorney appointed in writing by a person in interest, who requests a copy of a medical record of an individual enrolled in the Maryland Medical Assistance Program a fee that exceeds $20, adjusted annually for inflation in accordance with the Consumer Price Index, for each 100 pages or portion of 100 pages copied.

(7) Notwithstanding any other provision of law, any person or entity who is not subject to the provisions of this subsection and who obtains a medical record from a health care provider or the provider's agent may not charge a fee for any subsequent copies of that medical record that exceeds the fee authorized under paragraph (3)(i) of this subsection.

Payment of fees

(d) Except for an emergency request from a unit of State or local government concerning a child protective services case or adult protective services case, a health care provider may withhold copying until the fee for copying is paid.

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Health General §4-305: Permitted disclosure of medical record without authorization.

In general

(a) This section may not be construed to impose an obligation on a health care provider to disclose a medical record.

Disclosure of medical record

(b) A health care provider may disclose a medical record without the authorization of a person in interest:

            (1)(i) To the provider's authorized employees, agents, medical staff, medical students, or consultants for the sole purpose of offering, providing, evaluating, or seeking payment for health care to patients or recipients by the provider;
            (ii) To the provider's legal counsel regarding only the information in the medical record that relates to the subject matter of the representation; or
            (iii) To any provider's insurer or legal counsel, or the authorized employees or agents of a provider's insurer or legal counsel, for the sole purpose of handling a potential or actual claim against any provider if the medical record is maintained on the claimant and relates to the subject matter of the claim;

            (2) If the person given access to the medical record signs an acknowledgment of the duty under this Act not to redisclose any patient identifying information, to a person for:
            (i) Educational or research purposes, subject to the applicable requirements of an institutional review board;
            (ii) Evaluation and management of health care delivery systems; or
            (iii) Accreditation of a facility by professional standard setting entities;

(3) Subject to the additional limitations for a medical record developed primarily in connection with the provision of mental health services in § 4-307 of this subtitle, to a government agency performing its lawful duties as authorized by an act of the Maryland General Assembly or the United States Congress;

(4) Subject to the additional limitations for a medical record developed primarily in connection with the provision of mental health services in § 4-307 of this subtitle, to another health care provider for the sole purpose of treating the patient or recipient on whom the medical record is kept;

(5) If a claim has been or may be filed by, or with the authorization of a patient or recipient on behalf of the patient or recipient, for covered insureds, covered beneficiaries, or enrolled recipients only, to third party payors and their agents, if the payors or agents have met the applicable provisions of §§ 15-10B-01 to 15-10B-18 of the Insurance Article, including nonprofit health service plans, health maintenance organizations, fiscal intermediaries and carriers, the Department and its agents, the United States Department of Health and Human Services and its agents, or any other person obligated by contract or law to pay for the health care rendered for the sole purposes of:

            (i) Submitting a bill to the third party payor;
            (ii) Reasonable prospective, concurrent, or retrospective utilization review or predetermination of benefit coverage;
            (iii) Review, audit, and investigation of a specific claim for payment of benefits; or
            (iv) Coordinating benefit payments in accordance with the provisions of the Insurance Article under more than one sickness and accident, dental, or hospital and medical insurance policy;

(6) If a health care provider makes a professional determination that an immediate disclosure is necessary, to provide for the emergency health care needs of a patient or recipient;

(7) To immediate family members of the patient or any other individual with whom the patient is known to have a close personal relationship, provided that:

(i) The disclosure is limited to information that is directly relevant to the individual's involvement in the patient's health care; and
(ii) 1. If the patient is present or otherwise available before the disclosure and has the capacity to make health care decisions:

                        A. The patient has been provided with an opportunity to object to the disclosure and the patient has not objected; or
                        B. The health care provider reasonably infers from the circumstances that, based on the health care provider's professional judgment, the patient does not object to the disclosure; or
             2. If the patient is not present or otherwise available before the disclosure is made, or providing the patient with an opportunity to object to the disclosure is not practicable because of the patient's incapacity or need for emergency care or treatment, the health care provider determines, based on the health care provider's professional judgment, that the disclosure is in the best interests of the patient;

(8) To an appropriate organ, tissue, or eye recovery agency under the restrictions of § 5-408 of this article for a patient whose organs and tissues may be donated for the purpose of evaluating the patient for possible organ and tissue donation;

(9) To the Department or an organ, tissue, or eye recovery agency designated by the Department for the purpose of conducting death record reviews under § 19-310 of this article;

(10) Subject to subsection (c) of this section, if the purpose of the medical record disclosure is for the coordination of services and record retention within the Montgomery County Department of Health and Human Services; or

(11) To a carrier, as defined in § 15-1301 of the Insurance Article, or an accountable care organization, as defined in § 3022 of the Patient Protection and Affordable Care Act, for the sole purposes of enhancing or coordinating patient care, provided that:

            (i) A disclosure under this item is subject to the additional limitations in § 4-307 of this subtitle on disclosure of a medical record developed primarily in connection with the provision of mental health services;
            (ii) A medical record may be disclosed only in accordance with the federal Health Insurance Portability and Accountability Act of 1996, any regulations adopted under the Act, and any other applicable federal privacy laws, and disclosures under this item may not be made in violation of the prohibited uses or disclosures under the federal Health Insurance Portability and Accountability Act of 1996;
            (iii) A disclosure under this item may not be used for underwriting or utilization review purposes;
            (iv) A health care provider that discloses a medical record in accordance with this item shall provide a notice consistent with the requirements of 45 C.F.R. § 164.520 specifying the information to be shared, with whom it will be shared, and the specific types of uses and disclosures that the health care provider may make in accordance with this item;
            (v) The notice required by item (iv) of this item shall include an opportunity for the individual to opt out of the sharing of the individual's medical record with a carrier or an accountable care organization for the purposes identified in this item; and
            (vi) If a health care provider discloses medical information or medical data to a carrier or accountable care organization through an infrastructure that provides organizational and technical capabilities for the exchange of protected health information among entities not under common ownership, the health care providers are subject to the requirements of §§ 4-302.2 and 4-302.3 of this subtitle.

Montgomery County

(c) (1) The disclosure of medical records under subsection (b)(10) of this section to a person that is not employed by or under contract with the Montgomery County Department of Health and Human Services shall be conducted in accordance with this subtitle.

(2) Under provisions of State law regarding confidentiality, the Montgomery County Department of Health and Human Services shall be considered to be one agency.

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Health General §4-306: Mandatory disclosure of medical record without authorization.

In general

(a) In this section, “compulsory process” includes a subpoena, summons, warrant, or court order that appears on its face to have been issued on lawful authority.

Disclosure of medical record

(b) A health care provider shall disclose a medical record without the authorization of a person in interest:

(1) To a unit of State or local government, or to a member of a multidisciplinary team assisting the unit, for purposes of investigation or treatment in a case of suspected abuse or neglect of a child or an adult, subject to the following conditions:

(i) The health care provider shall disclose only the medical record of a person who is being assessed in an investigation or to whom services are being provided in accordance with Title 5, Subtitle 7 or Title 14, Subtitle 3 of the Family Law Article;
(ii) The health care provider shall disclose only the information in the medical record that will, in the professional judgment of the provider, contribute to the:

                        1. Assessment of risk;
                        2. Development of a service plan;
                        3. Implementation of a safety plan; or
                        4. Investigation of the suspected case of abuse or neglect; and

(iii) The medical record may be redisclosed as provided in §§ 1-201, 1-202, 1-204, and 1-205 of the Human Services Article;

(2) Subject to the additional limitations for a medical record developed primarily in connection with the provision of mental health services in § 4-307 of this subtitle, to health professional licensing and disciplinary boards, in accordance with a subpoena for medical records for the sole purpose of an investigation regarding:

(i) Licensure, certification, or discipline of a health professional; or
(ii) The improper practice of a health profession;

(3) To a health care provider or the provider's insurer or legal counsel, all information in a medical record relating to a patient or recipient's health, health care, or treatment which forms the basis for the issues of a claim in a civil action initiated by the patient, recipient, or person in interest;

(4) Notwithstanding any privilege in law, as needed, to a medical review committee as defined in § 1-401 of the Health Occupations Article or a dental review committee as defined in § 4-501 of the Health Occupations Article;

(5) To another health care provider as provided in § 10-807 or § 19-308.2 of this article;

(6) Subject to the additional limitations for a medical record developed primarily in connection with the provision of mental health services in § 4-307 of this subtitle and except as otherwise provided in items (2), (7), and (8) of this subsection, in accordance with compulsory process, if the health care provider receives:

(i) 1. A written assurance from the party or the attorney representing the party seeking the medical records that:

                        A. In a Child in Need of Assistance proceeding pursuant to Title 3, Subtitle 8 of the Courts and Judicial Proceedings Article, a person in interest has not objected to the disclosure of the designated medical records and 15 days have elapsed since the notice was sent;
                        B. In all other proceedings, a person in interest has not objected to the disclosure of the designated medical records within 30 days after the notice was sent; or
                        C. The objections of a person in interest have been resolved and the request for disclosure is in accordance with the resolution;

2. Proof that service of the subpoena, summons, warrant, or court order has been waived by the court for good cause; or

3. A copy of an order entered by a court expressly authorizing disclosure of the designated medical records; and

(ii) For disclosures made under item (i)1A of this item, copies of the following items that were mailed by certified mail to the person in interest by the person requesting the disclosure at least 15 days before the records are to be disclosed:

1. The subpoena, summons, warrant, or court order seeking the disclosure or production of the records;

2. This section;

(7) Subject to the additional limitations for a medical record developed primarily in connection with the provision of mental health services in § 4-307 of this subtitle, to grand juries, prosecution agencies, law enforcement agencies or their agents or employees to further an investigation or prosecution, pursuant to a subpoena, warrant, or court order for the sole purposes of investigating and prosecuting criminal activity, provided that the prosecution agencies and law enforcement agencies have written procedures to protect the confidentiality of the records;

(8) To the Maryland Insurance Administration when conducting an investigation or examination pursuant to Title 2, Subtitle 2 of the Insurance Article, provided that the Insurance Administration has written procedures to maintain the confidentiality of the records;

(9) To a State or local child fatality review team established under Title 5, Subtitle 7 of this article as necessary to carry out its official functions;

(10) To a local domestic violence fatality review team established under Title 4, Subtitle 7 of the Family Law Article as necessary to carry out its official functions;

(11) To a local drug overdose fatality review team established under Title 5, Subtitle 9 of this article as necessary to carry out its official functions, subject to:

(i) The additional limitations under § 4-307 of this subtitle for disclosure of a medical record developed primarily in connection with the provision of mental health services; and

(ii) Any additional limitations for disclosure or redisclosure of a medical record developed in connection with the provision of substance abuse treatment services under State law or 42 U.S.C. § 290dd-2 and 42 C.F.R. Part 2; or

(12) To a guardian ad litem appointed by a court to protect the best interests of a minor or a disabled or elderly individual who is a victim of a crime or a delinquent act, for the sole purpose and use of the guardian ad litem in carrying out the guardian ad litem's official function to protect the best interests of the minor or the disabled or elderly individual in a criminal or juvenile delinquency court proceeding as permitted under 42 C.F.R. § 164.512(e).

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Health General §4-307: Confidentiality of mental health records; disclosure.

Definitions

(a) (1) In this section the following words have the meanings indicated.

(2) “Case management” means an individualized recipient centered service designed to assist a recipient in obtaining effective mental health services through the assessing, planning, coordinating, and monitoring of services on behalf of the recipient.

(3) “Core service agency” has the meaning stated in § 7.5-101 of this article.

(4) “Director” means the Director of the Behavioral Health Administration or the designee of the Director.

(5) “Mental health director” means the health care professional who performs the functions of a clinical director or the designee of that person in a health care, detention, or correctional facility.

(6)(i) “Personal note” means information that is:

1. The work product and personal property of a mental health provider; and

2. Except as provided in subsection (d)(3) of this section, not discoverable or admissible as evidence in any criminal, civil, or administrative action.

(ii) Except as provided in subsection (d)(2) of this section, a medical record does not include a personal note of a mental health care provider, if the mental health care provider:

1. Keeps the personal note in the mental health care provider's sole possession for the provider's own personal use;

2. Maintains the personal note separate from the recipient's medical records; and

3. Does not disclose the personal note to any other person except:

A. The mental health provider's supervising health care provider that maintains the confidentiality of the personal note;

B. A consulting health care provider that maintains the confidentiality of the personal note; or

C. An attorney of the health care provider that maintains the confidentiality of the personal note.

(iii) “Personal note” does not include information concerning the patient's diagnosis, treatment plan, symptoms, prognosis, or progress notes.

Application of section

(b) The disclosure of a medical record developed in connection with the provision of mental health services shall be governed by the provisions of this section in addition to the other provisions of this subtitle.

Disclosure without authorization

(c) When a medical record developed in connection with the provision of mental health services is disclosed without the authorization of a person in interest, only the information in the record relevant to the purpose for which disclosure is sought may be released.

Personal notes

(d) (1) To the extent a mental health care provider determines it necessary and appropriate, the mental health care provider may maintain a personal note regarding a recipient.

(2) A personal note shall be considered part of a recipient's medical records if, at any time, a mental health care provider discloses a personal note to a person other than:

            (i) The provider's supervising health care provider;
            (ii) A consulting health care provider;
            (iii) An attorney of the health care provider; or
            (iv) A recipient under paragraph (3) of this subsection.

(3) The provisions of this subsection do not prohibit the disclosure, discovery, or admissibility of a personal note regarding a recipient who has initiated an action for malpractice, an intentional tort, or professional negligence against the health care provider.

Compromise of objectivity or fairness

(e) (1) Except as otherwise provided in paragraphs (3), (4), and (5) of this subsection, if the disclosure of a portion of a medical record relating to a psychological test would compromise the objectivity or fairness of the test or the testing process, a mental health care provider may not disclose that portion of the medical record to any person, including a subject of the test.

(2) The raw test data relating to a psychological test is only discoverable or admissible as evidence in a criminal, civil, or administrative action on the determination by the court or administrative hearing officer that the expert witness for the party seeking the raw test data is qualified by the appropriate training, education, or experience to interpret the results of that portion of the raw test data relating to the psychological test.

(3)(i) A recipient who has been the subject of a psychological test may designate a psychologist licensed under Title 18 of the Health Occupations Article or a psychiatrist licensed under Title 14 of the Health Occupations Article to whom a health care provider may disclose the medical record.
(ii) The recipient shall:

1. Request the disclosure authorized under this paragraph in writing; and

2. Comply with the provisions of § 4-304 of this subtitle.

(4) A health care provider may disclose a medical record relating to a psychological test as provided under § 4-305(b)(2)(i) of this subtitle.

(5) The provisions of this subsection may not restrict access to or affect the disclosure of a medical record which is also an education record under the federal Individuals with Disabilities Education Act, the federal Family Educational Rights and Privacy Act, or any federal and State regulations that have been adopted to implement those laws.

Right to obtain medical record

(f) Notwithstanding any other provision of this subtitle, a person in interest shall have the right to obtain a medical record of a recipient that is developed in conjunction with a mental health evaluation relating to obtaining or continuing employment, if the evaluation has been performed at the request of or on behalf of an employer or prospective employer:

(1) In connection with a civil action or U.S. Equal Employment Opportunity Commission complaint initiated by the person in interest; or

(2) On a written authorization of the employer or prospective employer.

Records relating to group or family therapy

(g) A health care provider may disclose a medical record that relates to and identifies more than one recipient in group or family therapy only:

(1) On the authorization of a person in interest for each recipient;

(2) As provided in this subtitle; or

(3) As otherwise provided by law.

Client information system

(h) This section may not be construed to prevent the disclosure of a medical record that relates to the provision of mental health services between or among the health care providers that participate in the approved plan of a core service agency or local behavioral health authority for the delivery of mental health services, if a recipient:

(1) Has received a current list of the participating providers; and

(2) Has signed a written agreement with the core service agency or local behavioral health authority to participate in the client information system developed by the agency.

Duty not to redisclose

(i) If an individual given access to a medical record that relates to the provision of mental health services signs an acknowledgment of the duty under this Act not to redisclose personal identifying information about a recipient, this section may not be construed to prevent the disclosure of the medical record for rate review, auditing, health planning, licensure, approval, or accreditation of a facility by governmental or professional standard setting entities.

Permitted disclosure, involuntary commitments

(j) (1) A health care provider may disclose a medical record without the authorization of a person in interest:

(i) To the medical or mental health director of a juvenile or adult detention or correctional facility if:

1. The recipient has been involuntarily committed under State law or a court order to the detention or correctional facility requesting the medical record; and

2. After a review of the medical record, the health care provider who is the custodian of the record is satisfied that disclosure is necessary for the proper care and treatment of the recipient;

(ii) As provided in § 5-609 of the Courts and Judicial Proceedings Article;

(iii) 1. If a health care provider is a facility as defined in § 10-101 of this article, to a law enforcement agency concerning a recipient who:

A. Has been admitted involuntarily or by court order to the facility; and

B. Is on an unauthorized absence or has otherwise left the facility without being discharged or released;

2. The facility director may disclose to the law enforcement agency identifying information and only such further information that the director believes is necessary to aid the law enforcement agency in locating and apprehending the recipient for the purpose of:

A. Safely returning the recipient to custody; or

B. Fulfilling the provisions of subparagraph (ii) of this paragraph;

(iv) If a health care provider is a facility as defined in § 10-101 of this article, the facility director may confirm or deny the presence in the facility of a recipient to a parent, guardian, next of kin, or any individual who has a significant interest in the status of the recipient if that individual has filed a missing persons report regarding the recipient; and

(v) To allow for the service of process or a court order in a facility when appropriate arrangements have been made with the facility director so as to minimize loss of confidentiality.

(2) When a disclosure is made under this subsection, documentation of the disclosure shall be inserted in the medical record of the recipient.

Permitted disclosure, transfers

(k) (1) A health care provider shall disclose a medical record without the authorization of a person in interest:

(i) To the medical or mental health director of a juvenile or adult detention or correctional facility or to another inpatient provider of mental health services in connection with the transfer of a recipient from an inpatient provider, if:

1. The health care provider with the records has determined that disclosure is necessary for the continuing provision of mental health services; and

2. The recipient is transferred:

A. As an involuntary commitment or by court order to the provider;

B. Under State law to a juvenile or adult detention or correctional facility; or

C. To a provider that is required by law or regulation to admit the recipient;

(ii) To the State designated protection and advocacy system for mentally ill individuals under the federal Protection and Advocacy for Mentally Ill Individuals Act of 1986, as amended, if:

1. The State designated protection and advocacy system has received a complaint regarding the recipient or the director of the system has certified in writing to the chief administrative officer of the health care provider that there is probable cause to believe that the recipient has been subject to abuse or neglect;

2. The recipient by reason of mental or physical condition is unable to authorize disclosure; and

3. A. The recipient does not have a legal guardian or other legal representative who has the authority to consent to the release of health care information; or

B. The legal guardian of the recipient is a representative of a State agency;

(iii) To another health care provider or legal counsel to the other health care provider prior to and in connection with or for use in a commitment proceeding in accordance with Title 10, Subtitle 6 or Title 12 of this article;

(iv) In accordance with a court order, other than compulsory process compelling disclosure, as permitted under § 9-109(d), § 9-109.1(d), or § 9-121(d) of the Courts and Judicial Proceedings Article, or as otherwise provided by law, to:

1. A court;

2. An administrative law judge;

3. A health claims arbitrator; or

4. A party to a court, administrative, or arbitration proceeding;

(v) In accordance with a subpoena for medical records on specific recipients:

1. To health professional licensing and disciplinary boards for the sole purpose of an investigation regarding licensure, certification, or discipline of a health professional or the improper practice of a health profession; and

2. To grand juries, prosecution agencies, and law enforcement agencies under the supervision of prosecution agencies for the sole purposes of investigation and prosecution of a provider for theft and fraud, related offenses, obstruction of justice, perjury, unlawful distribution of controlled substances, and of any criminal assault, neglect, patient abuse or sexual offense committed by the provider against a recipient, provided that the prosecution or law enforcement agency shall:

A. Have written procedures which shall be developed in consultation with the Director to maintain the medical records in a secure manner so as to protect the confidentiality of the records; and

B. In a criminal proceeding against a provider, to the maximum extent possible, remove and protect recipient identifying information from the medical records used in the proceeding; or

(vi) In the event of the death of a recipient, to the office of the medical examiner as authorized under § 5-309 or § 10-713 of this article.

(2) If a recipient believes that a medical record has been inappropriately obtained, maintained, or disclosed under paragraph (1)(vi) of this subsection, the recipient may petition the State prosecutor for an investigation of the allegation.

(3) Except in a proceeding relating to payment for the health care of a recipient, the medical record of a recipient and any information obtained as a result of disclosure under paragraph (1)(vi) of this subsection is disclosable, notwithstanding any privilege in law, but may not be used in any proceeding against the recipient.

(4) A written request for disclosure or written confirmation of an oral request in an emergency that justifies the need for disclosure shall be inserted in the medical record of the recipient.

(5) Documentation of the disclosure shall be inserted in the medical record of the recipient.

(6) This subsection may not preclude a health care provider, a recipient, or person in interest from asserting in a motion to quash or a motion for a protective order any constitutional right or other legal authority in opposition to disclosure.

Disclosure of medical and legal records to a public defender; without authorization

(l) (1) Subject to paragraphs (2) through (4) of this subsection, a health care provider shall disclose medical and legal records without the authorization of an individual to a public defender who states in writing that the Office of the Public Defender represents the individual in:

            (i) An involuntary admission proceeding under Title 10, Subtitle 6 of this article;
            (ii) A release proceeding under Title 10, Subtitle 8 of this article; or
            (iii) A commitment or release proceeding under Title 3 of the Criminal Procedure Article.

(2) Legal records required to be disclosed under paragraph (1) of this subsection include:

            (i) An emergency petition;
            (ii) An application for involuntary admission; and
            (iii) A certification for involuntary admission.

(3) The records disclosed under paragraph (1) of this subsection shall be limited to those records needed by the public defender to represent the individual in the proceedings listed in paragraph (1) of this subsection.

(4) Records provided under paragraph (1)(i) of this subsection shall be provided:

(i) Within 24 hours after the health care provider receives a written request for the records from the public defender; and
(ii) Only if the individual has not yet retained private counsel.

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Health General §4-308: Good faith disclosure of medical record.

A health care provider, who in good faith discloses or does not disclose a medical record, is not liable in any cause of action arising from the disclosure or nondisclosure of the medical record.

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Health General §4-309: Violations of subtitle.

In general

(a) If a health care provider knowingly refuses to disclose a medical record within a reasonable time but no more than 21 working days after the date a person in interest requests the disclosure, the health care provider is liable for actual damages.

Failure to pay

(b) A health care provider may not refuse to disclose a medical record on the request of a person in interest because of the failure of the person in interest to pay for health care rendered by the health care provider.

Disclosure violations

(c) A health care provider or any other person is in violation of this subtitle if the health care provider or any other person:

(1) Requests or obtains a medical record under false pretenses or through deception; or

(2) Discloses a medical record in violation of this subtitle.

Willful violations

(d) Except as otherwise provided in subsection (e) of this section, a health care provider or any other person, including an officer or employee of a governmental unit, who knowingly and willfully violates any provision of this subtitle is guilty of a misdemeanor and on conviction is subject to a fine not exceeding $1,000 for the first offense and not exceeding $5,000 for each subsequent conviction for a violation of any provision of this subtitle.

Obtaining medical record under deception

(e) (1) A health care provider or any other person, including an officer or employee of a governmental unit, who knowingly and willfully requests or obtains a medical record under false pretenses or through deception or knowingly and willfully discloses a medical record in violation of this subtitle is guilty of a misdemeanor and on conviction is subject to the following penalties:

            (i) A fine not exceeding $50,000, imprisonment for not more than 1 year, or both;
            (ii) If the offense is committed under false pretenses, a fine not exceeding $100,000, imprisonment for not more than 5 years, or both; and
            (iii) If the offense is committed with intent to sell, transfer, or use individually identifiable health information for commercial advantage, personal gain, or malicious harm, a fine not exceeding $250,000, imprisonment for not more than 10 years, or both.

(2) This subsection does not apply to an officer or employee of a governmental unit that is conducting a criminal investigation.

Liability for damages

(f) A health care provider or any other person who knowingly violates any provision of this subtitle is liable for actual damages.

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Health General §18-336: Informed consent for HIV testing.

Definitions

(a) (1) In this section the following words have the meanings indicated.

(2) “Health care facility” has the same meaning stated in § 18-338.2 of this subtitle.

(3) “Health care provider” means a physician, nurse, or designee of a health care facility.

(4) “HIV” means the human immunodeficiency virus that causes acquired immune deficiency syndrome.

Information provided to individuals unless HIV testing refused

(b) (1) Except as provided in Title 11, Subtitle 1, Part II of the Criminal Procedure Article or § 18-338.3 of this subtitle, before obtaining a fluid or tissue sample from the body of an individual for the purpose of testing the fluid or tissue for the presence of HIV infection, a health care provider shall:

(i) Inform the individual verbally or in writing that HIV testing will be performed on a specimen obtained from the individual unless the individual refuses HIV testing;

(ii) Provide the individual verbal or written information or show a video that includes an explanation of HIV infection and the meaning of positive and negative test results;

(iii) Offer the individual an opportunity to ask questions and decline HIV testing; and

(iv) If the individual refuses HIV testing, document in the medical record the individual's decision.

(2)(i) Consent for HIV testing shall be included in a patient's general informed consent for medical care in the same category as other screening and diagnostic tests.

(ii) Except as otherwise provided in this section, a health care provider may not be required to obtain consent for HIV testing using a separate consent form.

(3) A health care provider shall make available to individuals for whom HIV testing is performed easily understood informational materials in the languages of the commonly encountered populations of the health care provider.

Informed consent in writing

(c) (1) If the HIV test is ordered at a location that is not a health care facility, informed consent shall be in writing and signed by the individual on an informed consent for HIV testing document that is approved by the Department.

(2) The informed consent for HIV testing document shall be distinct and separate from all other consent forms.

(3) A patient identifying number obtained from an anonymous and confidential test site which is approved by the Department may be evidence of a patient's informed consent in lieu of a patient's signature.

Refusal to consent or positive test result not basis to deny services or treatment

(d) An individual's refusal to undergo an HIV test or a positive test result may not be used as the sole basis by an institution or laboratory to deny services or treatment.

Substitute consent

(e) If the individual is unable to give informed consent, substitute consent may be given under § 5-605 of this article.

Actions upon receipt of test results

(f) A health care provider who obtains a result from an HIV test conducted in accordance with the provisions of subsection (b) of this section shall:

(1) Notify the individual from whom the fluid or tissue sample was obtained of the result; and

(2) If the test is positive:

(i) Provide a referral for treatment and supportive services;

(ii) Counsel the individual to inform all sexual and needle-sharing partners of the individual's positive HIV status;

(iii) Offer to assist in notifying the individual's sexual and needle-sharing partners or refer the individual to the local health officer to assist the individual with notifying the individual's sexual and needle-sharing partners; and

(iv) If necessary, take action appropriate to comply with § 18-337 of this subtitle.

Information on referral resources

(g) Local health officers shall make available to health care providers in their jurisdiction information on referral resources for an individual with an HIV positive status, including counseling, testing, needs assessment, treatment, and support services.

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Health General §18-337: Notice of positive HIV result.

Health care provider defined

(a) In this section, “health care provider” means a physician, a physician's designee, or a designee of a health care facility licensed or otherwise authorized to provide health care services.

Notification of partners

(b) If an individual informed of the individual's HIV positive status under § 18-336 of this subtitle refuses to notify the individual's sexual and needle-sharing partners, the individual's physician may inform the local health officer and/or the individual's sexual and needle-sharing partners of:

(1) The individual's identity; and

(2) The circumstances giving rise to the notification.

Enforcement

(c) When the local health officer is notified, the health officer shall enforce the provisions of §§ 18-208 through 18-213.1 of this title:

(1) Within a reasonable time; and

(2) To the extent feasible.

Referral to services

(d) Each local health officer shall refer the infected individual and any known sexual or needle-sharing partners of the individual to appropriate services for the care, support, and treatment for HIV infected individuals.

Notification in good faith

(e) A physician acting in good faith to provide notification in accordance with this section may not be held liable in any cause of action related to a breach of patient confidentiality.

Disclosure in good faith

(f) A physician acting in good faith may not be held liable in any cause of action for choosing not to disclose information related to a positive test result for the presence of human immunodeficiency virus to an individual's sexual and needle-sharing partners.

Tests in good faith

(g) A hospital or any other health care provider acting in good faith pursuant to a physician's order to perform or interpret a test for the presence of HIV may not be held liable in any cause of action related to:

(1) A breach of patient confidentiality; or

(2) A physician's decision to disclose or not to disclose information related to a positive test result to a local health officer and/or an individual's sexual and needle-sharing partners.

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Organ and Tissue Donation

Health General §19-310: Donation of decedent’s organs.

In general

(a) (1) In this subsection, “designated requestor” means a hospital employee who has completed a course offered by an organ, tissue, or eye recovery agency on how to approach potential donor families and request organ or tissue donation.

(2)(i) On or before the occurrence of each death in a hospital, the hospital shall contact an appropriate organ, tissue, or eye recovery agency in order to determine the patient's suitability for organ, tissue, or eye donation.

(ii) The contact and its disposition shall be noted in the patient's medical record.

(3)(i) The appropriate organ, tissue, or eye recovery agency, in consultation with the patient's attending physician or the physician's designee, shall determine the patient's suitability for organ, tissue, or eye donation.

(ii) If the organ, tissue, or eye recovery agency, in consultation with the patient's attending physician or the physician's designee, determines that donation is not appropriate based on established medical criteria, this determination shall be noted by hospital personnel in the patient's medical record and no further action is necessary.

(iii) If the organ, tissue, or eye recovery agency, in consultation with the patient's attending physician or the physician's designee, determines that the patient is a suitable candidate for organ, tissue, or eye donation, a representative of the appropriate organ, tissue, or eye recovery agency or a designated requestor shall initiate a request under paragraph (4) of this subsection, if applicable.

(4)(i) Except as provided in the Maryland Revised Uniform Anatomical Gift Act, when an individual dies in a hospital in accordance with § 5-202 of this article, a representative of the appropriate organ, tissue, or eye recovery agency or a designated requestor shall request, with sensitivity and in compliance with § 4-507 of the Estates and Trusts Article, that the individual's representative consent to the donation of all or any of the decedent's organs or tissues as an anatomical donation if suitable.

(ii) Directions given by a person authorized under § 4-503 of the Estates and Trusts Article to make, amend, revoke, or refuse to make an anatomical gift of a decedent's body or parts shall be recorded in the decedent's medical record.

(iii) The representative of the appropriate organ, tissue, or eye recovery agency or the designated requestor and the representative of the deceased patient are entitled to protection from civil and criminal liability as provided in § 4-514 of the Estates and Trusts Article.

(5) In all discussions concerning donations of organs and tissues, the representative of the appropriate organ, tissue, or eye recovery agency or the designated requestor shall show reasonable discretion and sensitivity:

(i) To the circumstances of the family of the decedent;

(ii) To the religious beliefs of the decedent; and

(iii) To the nonsuitability for organ or tissue donation of the decedent.

(6)(i) When a representative of the appropriate organ, tissue, or eye recovery agency or a designated requestor makes a request under paragraph (4)(i) of this subsection, the representative or designated requestor shall document the request and its disposition as required by § 4-508 of the Estates and Trusts Article.

(ii) Hospital personnel shall note the request and its disposition in the decedent's medical record or death certificate.

(7) A hospital may not bill the estate of the decedent, a surviving spouse or domestic partner of the decedent, any heirs of the decedent, or an insurer of the decedent for the costs associated with the removal of all or any of the decedent's organs or tissues for the purpose of an anatomical donation.

(8) After consultation with the Maryland Hospital Association, Inc., the Medical and Chirurgical Faculty of the State of Maryland, Living Legacy Foundation, the Washington Regional Transplant Community, the Medical Eye Bank of Maryland, the Health Facilities Association of Maryland, and Tissue Banks International, the Secretary shall publish guidelines designed to implement this subsection, including guidelines:

(i) Requiring that, at or near the time of each individual death in a hospital, the hospital contact by telephone an appropriate organ, tissue, or eye recovery agency to determine the suitability of the individual for organ, tissue, and eye donation;

(ii) Requiring that each hospital designate a person to make the contact; and

(iii) Identifying the information that the person designated by the hospital shall have available before making the contact.

(9) The provisions of this subsection shall in no way interfere with the duties of the office of the Chief Medical Examiner. In sudden deaths under the jurisdiction of the office of the Chief Medical Examiner as provided in § 5-309 of this article, notification will be made to the office of the Chief Medical Examiner prior to organ removal.

(10) The consent of the decedent's representative is not necessary and the provisions of paragraph (4) of this subsection do not apply if § 4-506 of the Estates and Trusts Article precludes the decedent's representative from making an anatomical gift.

(11) A person who acts in good faith to recover organs or tissues in accordance with a notation on the decedent's driver's license or identification card that the decedent is an organ donor, a gift made in accordance with § 5-604.1 of this article or Title 4, Subtitle 5 of the Estates and Trusts Article, or a gift made in accordance with the anatomical gift laws of another state or country is immune from criminal prosecution and liability for damages in any cause of action related to the recovery and donation of the decedent's organs or tissues.

(12) The Department shall conduct annual death record reviews at each hospital to determine the hospital's compliance with the provisions of this subsection. The Department may delegate its duty to conduct annual death record reviews to the appropriate organ, tissue, or eye recovery agency serving the region in which a particular hospital is located.

Bone marrow donations

(b) (1) Subject to paragraph (2) of this subsection and notwithstanding any other provision of law, a hospital offering bone marrow transplant services shall allow an individual to donate bone marrow to any individual.

(2) An individual may donate bone marrow to another individual if a licensed physician determines, based on the physician's medical judgment, that the donation of the bone marrow is in the best interests of the donee and there is no substantial risk of medical injury to the donor.

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Estates and Trusts §4-501: Definitions.

In general

(a) In this subtitle the following words have the meanings indicated.

Agent

(b) “Agent” means an individual:

(1) Authorized to make health care decisions on behalf of a principal by a power of attorney for health care; or

(2) Expressly authorized to make an anatomical gift on behalf of a principal by a record signed by the principal.

Anatomical gift

(c) “Anatomical gift” means a donation of all or part of a human body to take effect after the donor's death for the purpose of transplantation, therapy, research, or education.

Decedent

(d) (1) “Decedent” means a deceased individual whose body or part is or may be the source of an anatomical gift.

(2) “Decedent” includes:

(i) A stillborn infant; and
(ii) Subject to restrictions imposed by law other than this subtitle, a fetus.

(3) “Decedent” does not include a blastocyst, embryo, or fetus that is the subject of an induced abortion.

Disinterested witness

(e) (1) “Disinterested witness” means a witness other than:

(i) A spouse, child, parent, sibling, grandchild, grandparent, or guardian of an individual who makes, amends, revokes, or refuses to make an anatomical gift; or
(ii) Another adult who exhibits special care and concern for an individual who makes, amends, revokes, or refuses to make an anatomical gift.

(2) “Disinterested witness” does not include a person to which an anatomical gift may pass under § 4-509 of this subtitle.

Document of gift

(f) (1) “Document of gift” means a donor card or any other record used to make an anatomical gift.

(2) “Document of gift” includes a statement or symbol on a driver's license, an identification card, or a donor registry.

Donor

(g) “Donor” means an individual whose body or part is the subject of an anatomical gift.

Donor registry

(h) “Donor registry” means a database that contains records of anatomical gifts and amendments to or revocations of anatomical gifts as provided in § 4-516 of this subtitle.

Driver’s license

(i) (1) “Driver's license” means a license or permit issued by the Motor Vehicle Administration to operate a vehicle, whether or not conditions are attached to the license or permit.

(2) “Driver's license” includes a learner's permit.

Emancipated minor

(j) “Emancipated minor” means a person under the age of 18 years who is:

(1) Married;

(2) A parent;

(3) Serving in the military;

(4) Emancipated by court order;

(5) Living separately from the parents of the person and is self-supporting; or

(6) Emancipated for another purpose recognized by law.

Eye bank

(k) “Eye bank” means a person that:

(1) Is licensed, accredited, or regulated under federal or state law to engage in the recovery, screening, testing, processing, storage, or distribution of human eyes or portions of human eyes;

(2) Is accredited by the Eye Bank Association of America or the American Association of Tissue Banks; and

(3) Has a permit issued in accordance with Title 17, Subtitle 3 of the Health--General Article.

Guardian

(l) (1) “Guardian” means a person appointed by a court to make decisions regarding the support, care, education, health, or welfare of an individual.

(2) “Guardian” does not include a guardian ad litem, unless the guardian ad litem is authorized by a court to consent to donation.

Hospital

(m) “Hospital” means a facility licensed as a hospital under the law of any state or a facility operated as a hospital by the United States, a state, or a subdivision of a state.

Identification card

(n) “Identification card” means an identification card issued by the Motor Vehicle Administration.

Know

(o) “Know” means to have actual knowledge.

Nontransplant tissue bank

(p) (1) “Nontransplant tissue bank” means a person that recovers, screens, procures, transports, stores, or arranges for the storage and distribution of a body or part solely for the purpose of research, training, or education.

(2) “Nontransplant tissue bank” includes:

            (i) The State Anatomy Board;
            (ii) A program for a purpose described in paragraph (1) of this subsection operated by officers or employees of the United States; or
            (iii) A nonprofit organization described in paragraph (1) of this subsection permitted to operate under § 5-409 of the Health--General Article.

(3) “Nontransplant tissue bank” does not include:

            (i) An eye bank;
            (ii) An organ procurement organization; or
            (iii) A transplant tissue bank.

OCME

(q) “OCME” means the Office of the Chief Medical Examiner.

Organ procurement organization

(r) “Organ procurement organization” means a person designated by the Secretary of the United States Department of Health and Human Services as an organ procurement organization.

Parent

(s) “Parent” means a parent whose parental rights have not been terminated.

Part

(t) (1) “Part” means an organ, an eye, or tissue of a human being.

(2) “Part” does not include the whole body.

Physician

(u) “Physician” means an individual authorized to practice medicine or osteopathy under the law of any state.

Procurement organization

(v) “Procurement organization” means an eye bank, an organ procurement organization, or a tissue bank.

Prospective donor

(w) (1) “Prospective donor” means an individual who is dead or whose death is imminent and has been determined by a procurement organization to have a part that could be medically suitable for transplantation, therapy, research, or education.

(2) “Prospective donor” does not include an individual who has made a refusal.

Reasonably available

(x) “Reasonably available” means able to be contacted by a procurement organization without undue effort and willing and able to act in a timely manner consistent with existing medical criteria necessary for the making of an anatomical gift.

Recipient

(y) “Recipient” means an individual into whose body a decedent's part has been or is intended to be transplanted.

Record

(z) “Record” means information that is inscribed on a tangible medium or is stored in an electronic or any other medium and is retrievable in perceivable form.

Refusal

(aa) “Refusal” means a record created under § 4-505 of this subtitle that expressly states an intent to bar other persons from making an anatomical gift of an individual's body or part.

Sign

(bb) “Sign” means to:

(1) Have present intent to authenticate or adopt a record; and

(2)(i) Execute or adopt a tangible symbol; or

(ii) Attach to or logically associate with the record an electronic symbol, sound, or process.

Technician

(cc) (1) “Technician” means an individual determined to be qualified to remove or process parts by an appropriate organization that is licensed, accredited, or regulated under federal or state law.

(2) “Technician” includes an enucleator.

Tissue

(dd) (1) “Tissue” means a portion of the human body other than an organ or eye.

(2) “Tissue” does not include:

(i) Blood unless the blood is donated for the purpose of research or education; or
(ii) An ovum or sperm for the purpose of creating an embryo to use in therapy, research, or education, unless the anatomical gift is made by the donor to the spouse of the donor.

Tissue bank

(ee) “Tissue bank” means a transplant tissue bank or nontransplant tissue bank.

Transplant hospital

(ff) “Transplant hospital” means a hospital that furnishes organ transplants and other medical and surgical specialty services required for the care of transplant patients.

Transplant tissue bank

(gg) “Transplant tissue bank” means a person that is licensed, accredited, or regulated under federal or State law to engage in the recovery, screening, testing, processing, storage, or distribution of tissue in accordance with Title 17, Subtitle 3 of the Health--General Article.

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Estates and Trusts §4-503: Anatomical gifts.

Persons qualified to make gift

(a) Subject to § 4-506 of this subtitle, an anatomical gift may be made during the life of a donor for the purpose of transplantation, therapy, research, or education by:

(1)(i) A donor who is an adult; or

(ii) A donor who is a minor, if the minor is:

1. Emancipated; or

2. Authorized under State law to apply for a driver's license because the donor is at least 15 years and 9 months old;

(2) An agent of a donor, unless a power of attorney for health care or other record prohibits the agent from making an anatomical gift;

(3) A parent of a donor, if the donor is an unemancipated minor; or

(4) A guardian of a donor.

Procedures for making gift

(b) A donor may make an anatomical gift:

(1) By authorizing a statement or symbol indicating that the donor has made an anatomical gift to be imprinted on the donor's driver's license or identification card;

(2) By will;

(3) During a terminal illness or an injury of the donor, by any form of communication addressed to at least two adults, at least one of whom is a disinterested witness; or

(4) As provided in subsection (c) of this section.

Donor cards and donor registry

(i) A donor card or other record signed by the donor or other person making the gift; or

(ii) Authorizing that a statement or symbol indicating that the donor has made an anatomical gift be included on a donor registry.

(2) If a donor or other person authorized to make an anatomical gift under this section is physically unable to sign a record, the record may be signed by another individual at the direction of the donor or other person and shall:

(i) Be witnessed by at least two adults, at least one of whom is a disinterested witness, who have signed at the request of the donor or other person; and

(ii) State that the record has been signed and witnessed as provided in item (i) of this paragraph.

Revocation, suspension, expiration or cancellation of driver’s license or identification card

(d) Revocation, suspension, expiration, or cancellation of a driver's license or an identification card that indicates an anatomical gift does not invalidate the gift.

Anatomical gifts by will

(e) (1) An anatomical gift made by will takes effect on the donor's death whether or not the will is probated.

(2) If a will that makes an anatomical gift is invalidated after the donor's death, the anatomical gift does not become invalid.

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Estates and Trusts §4-504: Amendment or revocation of anatomical gift.

Procedure to amend or revoke anatomical gift

(a) Subject to § 4-506 of this subtitle, a donor or any other person authorized to make an anatomical gift under § 4-503 of this subtitle may amend or revoke an anatomical gift by:

(1) A record signed by:

(i) The donor;

(ii) The other person; or

(iii) Subject to subsection (b) of this section, if the donor or other person is physically unable to sign, another individual acting at the direction of the donor or the other person; or

(2) A later-executed document of gift that expressly or by inconsistency amends or revokes the previous anatomical gift or portion of the anatomical gift.

Witness requirements

(b) A record signed in accordance with subsection (a)(1)(iii) of this section shall:

(1) Be witnessed by at least two adults, at least one of whom is a disinterested witness, who have signed at the request of the donor or the other person; and

(2) State that the record has been signed and witnessed as provided in item (1) of this subsection.

Destruction or cancellation of documents

(c) Subject to § 4-506 of this subtitle, a donor or any other person authorized to make an anatomical gift under § 4-503 of this subtitle may revoke the anatomical gift by the destruction or cancellation of the document of gift, or the portion of the document of gift used to make the gift, with the intent to revoke the gift.

Amendment or revocation during terminal illness of donor

(d) During a terminal illness of a donor, or while a donor is injured, the donor may amend or revoke an anatomical gift that was not made by will by any form of communication addressed to at least two adults, at least one of whom is a disinterested witness.

Anatomical gifts by will

(e) A donor who makes an anatomical gift by will may amend or revoke the gift in the manner provided for amendment or revocation of wills or as provided in subsection (a) of this section.

Driver’s licenses or identification cards

(f) (1) An anatomical gift made by a donor designation on a driver's license or an identification card may be revoked by giving written notice to the Motor Vehicle Administration in accordance with § 12-303 of the Transportation Article.

(2) A donor may make a gift by authorizing that a statement or symbol indicating that the donor has made a gift be included on a donor registry.

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Estates and Trusts §4-505: Refusal to make anatomical gift.

Procedure for refusal to make anatomical gift

(a) An individual may refuse to make an anatomical gift of the individual's body or part by:

(1) A record signed by:

(i) The individual; or

(ii) Subject to subsection (b) of this section, if the individual is physically unable to sign, another individual acting at the direction of the individual;

(2) The individual's will, whether or not the will is admitted to probate or invalidated after the individual's death; or

(3) During a terminal illness of the individual or while the individual is injured, any form of communication addressed to at least two adults, at least one of whom is a disinterested witness.

Witness requirements

(b) A record signed in accordance with subsection (a)(1)(ii) of this section shall:

(1) Be witnessed by at least two adults, at least one of whom is a disinterested witness, who have signed at the request of the individual; and

(2) State that the record has been signed and witnessed as provided in item (1) of this subsection.

Amendment or revocation of refusal

(1) In a manner for making a refusal provided in subsection (a) of this section;

(2) By subsequently making an anatomical gift in accordance with § 4-503 of this subtitle that is inconsistent with the refusal; or

(3) By destroying or canceling the record evidencing the refusal, or the portion of the record used to make the refusal, with the intent to revoke the refusal.

Refusal a bar to others making anatomical gift

(d) Except as otherwise provided in § 4-506(h) of this subtitle, in the absence of an express, contrary indication by the individual set forth in the refusal, an individual's unrevoked refusal to make an anatomical gift of the individual's body or part bars all other persons from making an anatomical gift of the individual's body or part.

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Estates and Trusts §4-506: Persons barred from making, amending, or revoking anatomical gift of donor.

In general

(a) Except as otherwise provided in subsection (g) of this section and subject to subsection (f) of this section, in the absence of an express, contrary indication by the donor, a person other than the donor is barred from making, amending, or revoking an anatomical gift of a donor's body or part if the donor made:

(1) An anatomical gift of the donor's body or part under § 4-503 of this subtitle; or

(2) An amendment to an anatomical gift of the donor's body or part under § 4-504 of this subtitle.

Revocation not a refusal to make anatomical gift

(b) A donor's revocation of an anatomical gift of the donor's body or part under § 4-504 of this subtitle is not a refusal and does not bar another person specified in § 4-501 or § 4-507 of this subtitle from making an anatomical gift of the donor's body or part under § 4-503 or § 4-508 of this subtitle.

Persons other than donor making, amending, or revoking gifts

(c) If a person other than a donor makes an unrevoked anatomical gift of the donor's body or part under § 4-503 of this subtitle, or an amendment to an anatomical gift of the donor's body or part under § 4-504 of this subtitle, another person may not make, amend, or revoke the gift of the donor's body or part under § 4-508 of this subtitle.

Revocation of gift by person other than donor

(d) A revocation of an anatomical gift of a donor's body or part under § 4-504 of this subtitle by a person other than the donor does not bar another person from making an anatomical gift of the body or part under § 4-503 or § 4-508 of this subtitle.

Anatomical gift of part not refusal to make gift of other part

(e) In the absence of an express, contrary indication by the donor or other person authorized to make an anatomical gift under § 4-503 of this subtitle, an anatomical gift of a part is not a refusal to give another part or a limitation on the making of an anatomical gift of another part at a later time by the donor or another person.

Anatomical gift for purpose not limitation on making gifts for other purposes

(f) In the absence of an express, contrary indication by the donor or other person authorized to make an anatomical gift under § 4-503 of this subtitle, an anatomical gift of a part for one or more of the purposes set forth in § 4-503 of this subtitle is not a limitation on the making of an anatomical gift of the part for any other purpose by the donor or other person under § 4-503 or § 4-508 of this subtitle.

Unemancipated minors

(g) If a donor who is an unemancipated minor dies, a reasonably available parent or guardian of the donor may revoke or amend an anatomical gift of the donor's body or part.

Unemancipated minors who’ve signed refusals

(h) If an unemancipated minor who signed a refusal dies, a reasonably available parent or guardian of the minor may revoke the minor's refusal.

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Estates and Trusts §4-507: Classes of individuals able to make anatomical gifts from decedent

In general

(a) Subject to subsections (b) and (c) of this section and except as prohibited under §§ 4-505 and 4-506 of this subtitle, in accordance with the order of priority listed, a member of one of the following classes of individuals who is reasonably available may make an anatomical gift of a decedent's body or part for the purpose of transplantation, therapy, research, or education:

(1) An agent of the decedent at the time of death who could have made an anatomical gift under § 4-503(b) of this subtitle immediately before the decedent's death;

(2) The persons who were acting as the guardians of the decedent at the time of the death of the decedent;

(3) The spouse or domestic partner of the decedent;

(4) The adult children of the decedent;

(5) The parents of the decedent;

(6) The adult siblings of the decedent;

(7) The adult grandchildren of the decedent;

(8) The grandparents of the decedent;

(9) An adult who exhibited special care and concern for the decedent; or

(10) Another person having the authority to dispose of the body of the decedent.

Objections to anatomical gifts

(b) (1) If there is more than one member of a class listed in subsection (a)(1), (3), (4), (5), (6), (7), or (9) of this section entitled to make an anatomical gift, an anatomical gift may be made by a member of the class unless that member or a person to which the gift may pass under § 4-509 of this subtitle knows of an objection by another member of the class.

(2) If an objection to an anatomical gift is known, the gift may be made only by a majority of the members of the class who are reasonably available.

Persons in prior class making or objecting to gift

(c) A person may not make an anatomical gift if, at the time of the decedent's death, a person in a prior class under subsection (a) of this section is reasonably available to make or to object to the making of an anatomical gift.

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Estates and Trusts §4-508: Anatomical gifts made by authorized persons.

Form of anatomical gift

(a) A person authorized to make an anatomical gift under § 4-507 of this subtitle may make an anatomical gift:

(1) By a document of gift signed by the person making the gift; or

(2) By an oral communication that is electronically recorded or is contemporaneously reduced to a record and signed by the individual receiving the oral communication.

Amendment or revocation of anatomical gift

(b) (1) Subject to subsection (c) of this section, an anatomical gift by a person authorized under § 4-507 of this subtitle may be amended or revoked orally or in a record by a reasonably available member of a prior class.

(2) If more than one member of a prior class is reasonably available, the gift made by a person authorized under § 4-507 of this subtitle may be:

(i) Amended only if a majority of the reasonably available members agree to the amendment; or

(ii) Revoked only if:

1. A majority of the reasonably available members agree to the revocation; or

2. The reasonably available members are equally divided as to whether to revoke the gift.

Time of revocation

(c) A revocation under subsection (b) of this section is effective only if, before an incision has been made to remove a part from the donor's body or before invasive procedures have begun to prepare the recipient, the procurement organization, transplant hospital, or physician or technician knows of the revocation.

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Estates and Trusts §4-509: Recipients of anatomical gifts.

Persons, hospitals, or schools named in document of gift

(a) An anatomical gift may be made to the following persons named in a document of gift:

(1) A hospital, an accredited medical school, a dental school, a college or university, an organ procurement organization, the State Anatomy Board, or a nontransplant tissue bank for research, training, or education;

(2) Subject to subsection (b) of this section, if the individual is the recipient of the part, an individual designated by the person making the anatomical gift; or

(3) An eye bank or a transplant tissue bank.

Individuals not able to accept gift

(b) If an anatomical gift to an individual under subsection (a)(2) of this section cannot be transplanted into the individual, the part passes in accordance with subsection (g) of this section in the absence of an express, contrary indication by the person making the anatomical gift.

Purpose of anatomical gift

(c) If an anatomical gift of one or more specific parts or of all parts is made in a document of gift that does not name a person described in subsection (a) of this section but identifies the purpose for which an anatomical gift may be used, the following provisions apply:

(1) If the part is an eye and the gift is for the purpose of transplantation or therapy, the gift passes to the appropriate eye bank;

(2) If the part is tissue and the gift is for the purpose of transplantation or therapy, the gift passes to the appropriate tissue bank;

(3) If the part is an organ and the gift is for the purpose of transplantation or therapy, the gift passes to the appropriate organ procurement organization as custodian of the organ; or

(4) If the part is an organ, an eye, or tissue and the gift is for the purpose of research or education, the gift passes to the appropriate procurement organization.

Multiple purposes of anatomical gift

(d) For the purpose of subsection (c) of this section, if there is more than one purpose of an anatomical gift set forth in the document of gift but the purposes are not set forth in any priority, the gift shall be used:

(1) For transplantation or therapy, if suitable; or

(2) If the gift cannot be used for transplantation or therapy, for research or education.

Recipient or purpose not specified in anatomical gift

(e) If an anatomical gift of one or more specific parts is made in a document of gift that does not name a person described in subsection (a) of this section and does not identify the purpose of the gift, the gift passes in accordance with subsection (g) of this section and may be used only for transplantation or therapy.

Gifts specifying general intent only

(f) If a document of gift specifies only a general intent to make an anatomical gift by words such as “donor”, “organ donor”, or “body donor”, or by a symbol or statement of similar import, the gift passes in accordance with subsection (g) of this section and may be used only for transplantation or therapy.

Anatomical gift of eyes or tissue

(g) For purposes of subsections (b), (e), and (f) of this section, the following provisions apply:

(1) If the part is an eye, the gift passes to the appropriate eye bank;

(2) If the part is tissue, the gift passes to the appropriate tissue bank; and

(3) If the part is an organ, the gift passes to the appropriate organ procurement organization as custodian of the organ.

Anatomical gift of organ

(h) Other than an anatomical gift under subsection (a)(2) of this section, an anatomical gift of an organ for transplantation or therapy, research, or education passes to the organ procurement organization as custodian of the organ.

Disposal of body or part

(i) If an anatomical gift does not pass in accordance with subsections (a) through (h) of this section, or the decedent's body or part is not used for transplantation, therapy, research, or education, custody of the body or part passes to the person under obligation to dispose of the body or part.

Persons required to refuse anatomical gift

(j) (1) A person may not accept an anatomical gift if the person knows that:

(i) The gift was not effectively made under § 4-503 or § 4-508 of this subtitle; or

(ii) The decedent made a refusal under § 4-505 of this subtitle that was not revoked.

(2) For purposes of this subsection, if a person knows that an anatomical gift was made on a document of gift, the person is deemed to know of any amendment or revocation of the gift or any refusal to make an anatomical gift on the same document of gift.

Allocation of organs

(k) Except as otherwise provided in subsection (a)(2) of this section, nothing in this subtitle affects the allocation of organs for transplantation or therapy.

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Estates and Trusts §4-509.1: Repealed.

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Estates and Trusts §4-510: Persons required to make reasonable search for documents of potential donor.

Persons required to search for gift information

(a) The following persons shall make a reasonable search of an individual who the person reasonably believes is dead or whose death is imminent for a document of gift or any other information identifying the individual as a donor or as an individual who made a refusal:

(1) A law enforcement officer, firefighter, paramedic, or any other emergency rescuer finding the individual; and

(2) If no other source of the information is immediately available, a hospital, as soon as practical after the individual's arrival at the hospital.

Duty to send gift or refusal to hospital

(b) If a document of gift or a refusal to make an anatomical gift is located by the search required under subsection (a)(1) of this section and the individual or deceased individual to whom it relates is taken to a hospital, the person responsible for conducting the search shall send the document of gift or refusal to the hospital.

Liability or administrative sanctions

(c) A person is not subject to criminal or civil liability for failing to discharge the duties imposed by this section but may be subject to administrative sanctions.

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Estates and Trusts §4-511: Delivery of document of gift.

Effectiveness of document

(a) A document of gift need not be delivered during the lifetime of a donor to be effective.

Persons allowed to examine or copy document of gift

(b) On or after the death of an individual, a person in possession of a document of gift or a refusal to make an anatomical gift regarding the individual shall allow examination and copying of the document of gift or refusal by:

(1) A person authorized to make or object to the making of the anatomical gift; or

(2) A person to which the gift could pass under § 4-509 of this subtitle.

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Estates and Trusts §4-512: Referrals to procurement organizations.

Duty of hospital to search donor registry

(a) Whenever a hospital refers an individual who is dead or whose death is imminent to a procurement organization to ascertain whether the individual has made an anatomical gift, the organization shall make a reasonable search of any donor registry that the hospital knows exists for the geographical area in which the individual resides.

Duty of organization to determine suitability of donation

(b) (1) When a hospital refers an individual who is dead or whose death is imminent to a procurement organization, the organization may conduct any reasonable examination necessary to ensure the medical suitability of a part that is or could be the subject of an anatomical gift for transplantation, therapy, research, or education.

(2) During the examination period, measures necessary to ensure the medical suitability of a part from a prospective donor:

(i) May not be withdrawn unless the hospital or procurement organization knows that the individual expressed a contrary intent; and

(ii) May be administered, unless it is determined that the administration of those measures would not provide the prospective donor with appropriate end-of-life care consistent with reasonable medical judgment.

Duty of persons to determine suitability of body or part

(c) Unless prohibited by law other than this subtitle, at any time after a donor's death, the person to which a part passes under § 4-509of this subtitle may conduct a reasonable examination necessary to ensure the medical suitability of the body or part for its intended purpose.

Scope of examination

(d) Unless prohibited by law other than this subtitle, an examination under subsection (b) or (c) of this section may include an examination of all medical and dental records of the donor or prospective donor.

Duty of procurement organization to search for parents of minor

(e) On the death of a minor who was a donor or had signed a refusal, unless a procurement organization knows that the minor is emancipated, the procurement organization shall conduct a reasonable search for the parents of the minor and provide the parents with an opportunity to revoke or amend the anatomical gift or revoke the refusal.

Duty of procurement organization to search for persons able to make gift

(f) (1) On a referral by a hospital under subsection (a) of this section, a procurement organization shall make a reasonable search for a person listed in § 4-507 of this subtitle having priority to make an anatomical gift on behalf of a prospective donor.

(2) If a procurement organization receives information that an anatomical gift to any other person was made, amended, or revoked, the procurement organization shall promptly advise the other person of all relevant information.

Acceptance or rejection of anatomical gift

(g) (1) Subject to §§ 4-509(i) and 4-519 of this subtitle, after the death of the donor, the rights of a person to which a part passes under § 4-509 of this subtitle are superior to the rights of all others with respect to the part.

(2) The person to which a part passes under § 4-509 of this subtitle may accept or reject an anatomical gift in whole or in part.

(3) Subject to the terms of a document of gift and this subtitle, a person that accepts an anatomical gift of an entire body may allow embalming, burial, or cremation, and the use of remains in a funeral service.

(4) If an anatomical gift of a part is made under § 4-509 of this subtitle, on the death of the donor and before embalming, burial, or cremation, the person to which the part passes shall have the part removed without unnecessary mutilation.

Restrictions relating to participation in removing or transplanting part

(h) A physician who attends a decedent at death and a physician who determines the time of a decedent's death may not participate in the procedures for removing or transplanting a part from the decedent.

Removal of donated part

(i) (1) A physician or technician may remove a donated part from the body of a donor that the physician or technician is qualified to remove.

(2) An organ procurement organization may recover a donated body part from the body of a donor on behalf of an eye bank or tissue bank.

Agreements between hospitals and procurement organizations

(j) Each hospital in the State shall enter into an agreement or affiliation with a procurement organization for coordination of procurement and use of anatomical gifts.

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Estates and Trusts §4-513: Prohibited acts.

Purchase or sale of part for transplantation or therapy prohibited

(a) (1) Except as provided in subsection (b) of this section, if removal of a part from an individual is intended to occur after the individual's death, a person may not for valuable consideration knowingly purchase or sell the part for transplantation or therapy.

(2) A person that violates paragraph (1) of this subsection is guilty of a felony and on conviction is subject to a fine not exceeding $50,000 or imprisonment not exceeding 5 years or both.

Charges for actions related to donated parts

(b) (1) A person may charge a reasonable amount of money for the removal, processing, preservation, quality control, storage, transportation, implantation, or disposal of a part.

(2) The prohibition in subsection (a) of this section does not apply to blood and plasma.

Falsification, forgery, or concealment of documents of gift or refusal prohibited

(c) (1) A person may not, in order to obtain financial gain, intentionally falsify, forge, conceal, deface, or obliterate a document of gift, an amendment or revocation of a document of gift, or a refusal.

(2) A person who violates paragraph (1) of this subsection is guilty of a felony and on conviction is subject to a fine not exceeding $50,000 or imprisonment not exceeding 5 years or both.

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Estates and Trusts §4-514: No liability for persons acting in good faith.

Persons acting in good faith

(a) A person that acts in accordance with this subtitle or with the applicable anatomical gift law of another state, or attempts in good faith to do so, is not liable for the act in a civil action, a criminal prosecution, or an administrative proceeding.

Making or use of anatomical gift

(b) A person making an anatomical gift or the donor's estate is not liable for any injury or damage that results from the making or use of the gift.

Representations of individuals

(c) In determining whether an anatomical gift has been made, amended, or revoked under this subtitle, a person may rely on representations of an individual listed in § 4-507(a)(2) through (9) of this subtitle relating to the individual's relationship to the donor or prospective donor unless the person knows that the representation is untrue.

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Estates and Trusts §4-515: Validity of document of gift.

In general

(a) A document of gift is valid if executed in accordance with:

(1) This subtitle;

(2) The laws of the state or country where it was executed; or

(3) The laws of the state or country where the person making the anatomical gift was domiciled, has a place of residence, or was a national at the time the document of gift was executed.

Interpretation of document

(b) If a document of gift is valid under this section, the law of this State governs the interpretation of the document of gift.

Presumption of validity

(c) A person may presume that a document of gift or an amendment of an anatomical gift is valid unless that person knows that it was not validly executed or was revoked.

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Estates and Trusts §4-516: Donor registry requirements.

Qualified nonprofit entity defined

(a) In this section, “qualified nonprofit entity” means a procurement organization exempt from taxation under § 501(c)(3) of the Internal Revenue Code or an entity exempt from taxation under § 501(c)(3) of the Internal Revenue Code that actively functions in a supporting relationship to one or more procurement organizations if the procurement organization or other entity has a board of directors whose members are experienced in:

(1) Organ, tissue, and eye donation;

(2) Working with donors and donor families; and

(3) Educating the public about the importance of the process of organ, tissue, and eye donation.

Donor registry operated by nonprofit entity

(b) (1) The Secretary of Health shall contract with a qualified nonprofit entity for the establishment, maintenance, and operation of a donor registry.

(2) The Secretary of Health shall use funds from the Organ and Tissue Donation Awareness Fund as required under § 13-901 of the Health--General Article and any other funds as may be appropriate to compensate the nonprofit entity contracted with under paragraph (1) of this subsection for the reasonable cost of establishing, maintaining, and operating the donor registry, including the reasonable cost of public education programs to increase public awareness about the existence and purpose of the registry and organ, tissue, and eye donation.

Cooperation with Motor Vehicle Administration

(c) The Motor Vehicle Administration shall cooperate with the qualified nonprofit entity contracted with under subsection (b)(1) of this section for the purpose of transferring to the donor registry all relevant information regarding a donor's making, amending of, or revoking of an anatomical gift.

Accessibility of donor registry

(d) A donor registry shall be accessible 24 hours a day and 7 days a week to allow:

(1) A donor to include on the donor registry a statement or symbol that the donor has made or amended an anatomical gift;

(2) A donor to revoke an anatomical gift; or

(3) A procurement organization to obtain relevant information on the donor registry to determine, at the death or imminent death of a donor or a prospective donor, whether the donor or prospective donor has made, amended, or revoked an anatomical gift.

Confidentiality of personally identifiable information

(e) Personally identifiable information on a donor registry about a donor or prospective donor may not be used or disclosed without the express consent of the donor, prospective donor, or person that made the anatomical gift for any purpose other than to determine, at the death or imminent death of the donor or prospective donor, whether the donor or prospective donor has made or amended an anatomical gift.

Registries not established by or under contract with State

(f) (1) This section does not prohibit a person from creating or maintaining a donor registry that is not established by or under contract with the State.

(2) A registry that is not established by or under contract with the State shall comply with subsections (d) and (e) of this section.

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Estates and Trusts §4-517: Advance health care directives.

Advance health care directive defined

(a) In this section, “advance health care directive” means a power of attorney for health care or a record signed or authorized by a prospective donor in accordance with §§ 5-601 through 5-618 of the Health--General Article containing the prospective donor's direction concerning a health-care decision for the prospective donor.

Conflict between anatomical gift and health care directive

(b) (1)(i) If a prospective donor has a declaration or advance health care directive and the terms of the declaration or directive and the express or implied terms of a potential anatomical gift are in conflict with regard to the administration of measures necessary to ensure the medical suitability of a part for transplantation or therapy:

1. The prospective donor's attending physician and prospective donor shall confer to resolve the conflict; or

2. If the prospective donor is incapable of resolving the conflict, an agent acting under the prospective donor's declaration or directive shall act for the donor to resolve the conflict.

(ii) If there is not an agent or the agent is not reasonably available, another person authorized by a law other than this subtitle to make health care decisions on behalf of the prospective donor shall act for the donor to resolve the conflict.

(2) Information relevant to the resolution of the conflict under this subsection may be obtained from the appropriate procurement organization and any other person authorized to make an anatomical gift for the prospective donor under § 4-507 of this subtitle.

(3) Before resolution of a conflict under this subsection, measures necessary to ensure the medical suitability of a part from a prospective donor may be administered unless it is determined that the administration of those measures would not provide the prospective donor with appropriate end-of-life care, consistent with reasonable medical judgment.

(4) If the conflict under this subsection is not resolved expeditiously, the direction of the declaration or advance health care directive controls.

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Estates and Trusts §4-518: Cooperation between Office of the Chief Medical Examiner and procurement organizations.

Duty of OCME and procurement organizations to cooperate with each other

(a) OCME and procurement organizations shall cooperate with each other to maximize the opportunity to recover anatomical gifts for the purpose of transplantation, therapy, research, or education.

Postmortem examination of body

(b) If OCME receives notice from a procurement organization that an anatomical gift might be available or was made with respect to a decedent whose body or part is under the jurisdiction of OCME and a postmortem examination is going to be performed, unless OCME denies recovery in accordance with § 4-519 of this subtitle, OCME or OCME's designee shall conduct the postmortem examination of the body or part in a manner and within a period compatible with its preservation for the purposes of the gift.

Removal of part prohibited unless part of gift or authorized by OCME

(c) (1) A part may not be removed from the body of a decedent under the jurisdiction of OCME for transplantation, therapy, research, or education unless the part is the subject of an anatomical gift or an authorization given by OCME in accordance with subsection (d) of this section.

(2) The body of a decedent under the jurisdiction of OCME may not be delivered to a person for research or education unless the body is the subject of an anatomical gift or an authorization given by OCME in accordance with subsection (d) of this section.

(3) This subsection does not preclude OCME from performing a postmortem examination of the body or part of a decedent under the jurisdiction of OCME for the purposes of education, training, and research required by OCME.

Anatomical parts provided by medical examiners

(d) (1) The Chief Medical Examiner, the deputy chief medical examiner, or an assistant medical examiner may provide a part on the request of a procurement organization under the following conditions:

(i) The medical examiner has charge of a decedent who may provide a suitable part for transplant;

(ii) A reasonable, unsuccessful search has been made by the procurement organization as required by § 4-512(f) of this subtitle to contact the persons authorized under § 4-507 of this subtitle to make an anatomical gift;

(iii) No objection by the persons authorized under § 4-507 of this subtitle to make an anatomical gift is known by the medical examiner; and

(iv) The provision of the part for transplant will not interfere with the subsequent course of an investigation or autopsy.

(2)(i) If the Chief Medical Examiner has obtained a written or verbal statement from the procurement organization that a reasonable, unsuccessful search was conducted prior to the removal of a part for transplantation, the Chief Medical Examiner, the deputy chief medical examiner, an assistant chief medical examiner, and the procurement organization are not civilly liable if a person authorized under § 4-507 of this subtitle to make an anatomical gift is subsequently located and contends that the authorization of that person was required to make the gift.

(ii) A verbal statement under subparagraph (1) of this paragraph shall be documented in the medical record of the decedent.

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Estates and Trusts §4-518: Protocols and procedures for anatomical gifts.

Release of information related to anatomical gift

(a) (1) On request of a procurement organization, OCME shall release to the procurement organization the name, contact information, and available medical and social history of a decedent whose body is under the jurisdiction of OCME.

(2) If a body or part of a decedent is medically suitable for transplantation, therapy, research, or education, OCME shall release postmortem examination results to the procurement organization that made a request under paragraph (1) of this subsection.

(3) If relevant to transplantation or therapy, a procurement organization may make a subsequent disclosure of the postmortem examination results or other information received from OCME.

Postmortem examination by OCME

(b) OCME may conduct a postmortem examination by reviewing medical records, laboratory test results, X-rays, other diagnostic results, and other information that OCME determines may be relevant to the examination.

Information provided by OCME upon request

(c) A person that has information requested by OCME in accordance with subsection (b) of this section, shall provide the information as expeditiously as possible to allow OCME to conduct the postmortem examination within a period compatible with the preservation of parts for the purpose of transplantation, therapy, research, or education.

Cooperation for timely removal of part

(d) OCME and a procurement organization shall cooperate in the timely removal of a part from a decedent if:

(1) An anatomical gift has been or might be made of a part of the decedent whose body is under the jurisdiction of OCME and a postmortem examination is not required; or

(2) OCME determines that a postmortem examination is required but that the recovery of the part that is the subject of the anatomical gift will not interfere with the examination.

Agreements relating to protocols and procedures

(e) (1) OCME and procurement organizations shall enter into an agreement setting forth protocols and procedures to govern relations between the parties when an anatomical gift of a part from a decedent under the jurisdiction of OCME has been or might be made, but OCME believes that the recovery of the part could interfere with the postmortem examination into the decedent's cause or manner of death.

(2) Decisions regarding the recovery of organs, tissue, and eyes under this subsection shall be made in accordance with the agreement described in paragraph (1) of this subsection.

(3) If OCME denies recovery of an anatomical gift, the procurement organization may request that OCME reconsider the denial and allow the recovery to proceed.

(4) The parties shall evaluate the effectiveness of the protocols and procedures agreed to under this subsection at regular intervals, but no less frequently than every 2 years.

Record by physician or technician who removes part

(f) If OCME or a designee allows recovery of a part under subsection (d) or (e) of this section, on request, the procurement organization shall cause the physician or technician who removes the part to provide OCME with a record describing the condition of the part, a biopsy, a photograph, and any other information and observations that would assist in the postmortem examination.

Presence of OCME at removal procedure

(g) If OCME or a designee is required to be present at a removal procedure under subsection (e) of this section, on request, the procurement organization requesting the recovery of the part shall reimburse OCME or a designee for the additional costs incurred in complying with subsection (f) of this section.

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Estates and Trusts §4-520: Application and construction of subtitle.

In applying and construing this subtitle, which is a uniform act, consideration shall be given to the need to promote uniformity of the law with respect to its subject matter among states that enact the provisions of this subtitle.

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Estates and Trusts §4-521: Construction of subtitle with Electronic Signatures in Global and National Commerce Act.

This subtitle modifies, limits, and supersedes the Electronic Signatures in Global and National Commerce Act, 15 U.S.C. Section 7001 et seq., but does not modify, limit, or supersede Section 101(a) of that act, 15 U.S.C. Section 7001 et seq., or authorize electronic delivery of any of the notices described in Section 103(b) of that act, 15 U.S.C. Section 7003(b).

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Estates and Trusts §4-522: Short title.

This subtitle may be cited as the Maryland Revised Uniform Anatomical Gift Act.

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Drugs

Health General §21-223: Approved applications required to sell, give away, or deliver new drugs.

Scope of section

(a) This section does not apply to any drug that:

(1) Was sold in this State or introduced into interstate commerce at any time before the enactment of the federal act, if its labeling contained the same representations concerning the conditions of its use; or

(2) Is licensed under the Public Health Service Act1 of July 1, 1944 or under the Animal Virus, Serum, Toxin, Antitoxin Act2 of March 4, 1913.

In general

(b) A person may not sell, give away, or deliver any new drug:

(1) Unless an approved application for the drug is in effect under § 355 of the federal act; or

(2) Unless an application has been approved by the Secretary and is in effect under this section, if the drug is not subject to the federal act.

Filing of application with Secretary

(c) To have an application approved by the Secretary, an applicant shall file with the Secretary an application that sets forth:

(1) Full reports of the investigations that have been made to show whether the drug is safe for use and whether the drug is effective in use;

(2) A full statement of the composition of the drug;

(3) A full description of the methods used in, and the facilities and controls used for, the manufacture, processing, and packing of the drug;

(4) Any sample of the drug and of any article used as a component of the drug that the Secretary requires; and

(5) A specimen of the labeling that is proposed to be used for the drug.

Standard for approval

(d) The Secretary may not approve an application filed under this section unless the drug has been tested and, under the conditions specified, recommended, or suggested in the proposed labeling of the drug, has been found to be safe for and effective in use.

Approval, disapproval of applications

(e) An application filed with the Secretary under this section shall be considered approved on the 180th day after it is filed, unless before that day and after giving the applicant notice and an opportunity for a hearing, the Secretary issues an order of disapproval under subsection (f) of this section on a finding that:

(1) The drug has not been tested properly, as required by subsection (d) of this section;

(2) Under the conditions specified, recommended, or suggested in the proposed labeling of the drug, it is not safe for or effective in use;

(3) The methods used in, and the facilities and controls used for, the manufacture, processing, and packing of the drug are inadequate to preserve its identity, strength, quality, and purity; or

(4) Based on a fair evaluation of all material facts, the proposed labeling is false or misleading in any way.

Order of disapproval

(f) If, before the date that the application otherwise would be considered approved the Secretary makes any of the findings that are enumerated in subsection (e) of this section concerning the drug, the Secretary shall issue an order that disapproves the application.

Revocation of approval or disapproval

(g) (1) The Secretary may revoke an order that disapproved an application and the application then shall be considered approved.

(2) After providing an opportunity for a public hearing and judicial appeal, the Secretary may revoke an application that was approved under this section if, based on evidence that is acquired after approval, the Secretary finds that:

(i) The drug may not be safe for or effective in its intended use; or

(ii) The facilities or controls used in the manufacture, processing, or labeling of the drug may present a hazard to the public health.

Records and reporting requirements

(h) In accordance with any rule or regulation that is adopted or any order that is issued by the Secretary under this section, the person who holds an application for a drug that is approved under this section shall:

(1) Keep records; and

(2) Submit reports to the Secretary.

Rules and regulations

(i) (1) The Secretary may adopt rules and regulations that apply generally to persons whose applications for drugs have been approved or, as to a particular person whose application has been approved, issue an order that requires an applicant:

(i) To keep records of information that relates to clinical experience with the drug and any other information that the applicant obtains about the drug; and

(ii) To submit reports to the Secretary concerning that information.

(2) When adopting a rule or regulation or issuing an order that requires the submission of information under this subsection, the Secretary shall consider the professional ethics of the medical profession and the interests of patients.

(3) Any rule, regulation, or order under this section shall provide that if any person to whom the rule, regulation, or order applies requests it, and if the Secretary considers it to be appropriate, the person may examine similar information that is obtained by the Secretary concerning the drug.

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Legal Requirements in the District of Columbia pertaining to research with human participants

Legal Requirements in the State of Florida pertaining to research with human participants

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Relevant State Law Requirements

Research

Clinical Practice

Research

Health-General §13-2001: Definitions

Health-General §13-2002: Construction with federal regulations.

Health-General §13-2003: Minutes of institutional review boards.

Health-General §13-2004: Actions by Attorney General

Health-General §18-201: Duty of physician to report contagious diseases.

Health-General §18-201.1: Duty of physician to report HIV/AIDS.

Health-General §18-205: Duty of laboratory to report infectious or contagious disease.

Clinical Practice

Guardianship and Decision-making

Family Law §5-203: Natural guardianship; powers and duties of parents; award of custody to parent.

Family Law §9.5-101: Definition of “Child”.

Health General §5-605: Authorization of Surrogate.

Health-General §20-102: Consent to Medical treatment by minor.

Abuse

Family Law §5-704: Reports of suspected abuse or neglect; health practitioners, police officers, educators, and human service workers.

Family Law §5-705: Reports of suspected abuse or neglect; other persons.

Family Law §5-705.1: Abuse or neglect occurring outside the State.

Family Law §14-302: Mandatory reporting.

Privacy and Confidentiality

Health General §4-301: Definitions.

Health General §4-302: Confidentiality of medical records; disclosure.

Health General §4-303: Authorization to disclose medical records.

Health General §4-304: Medical records; copy fees.

Health General §4-305: Permitted disclosure of medical record without authorization.

Health General §4-306: Mandatory disclosure of medical record without authorization.

Health General §4-307: Confidentiality of mental health records; disclosure.

Health General §4-308: Good faith disclosure of medical record.

Health General §4-309: Violations of subtitle.

Health General §18-336: Informed consent for HIV testing.

Health General §18-337: Notice of positive HIV result.

Organ and Tissue Donation

Health General §19-310: Donation of decedent’s organs.

Estates and Trusts §4-501: Definitions.

Estates and Trusts §4-503: Anatomical gifts.

Estates and Trusts §4-504: Amendment or revocation of anatomical gift.

Estates and Trusts §4-505: Refusal to make anatomical gift.

Estates and Trusts §4-506: Persons barred from making, amending, or revoking anatomical gift of donor.

Estates and Trusts §4-507: Classes of individuals able to make anatomical gifts from decedent

Estates and Trusts §4-508: Anatomical gifts made by authorized persons.

Estates and Trusts §4-509: Recipients of anatomical gifts.

Estates and Trusts §4-509.1: Repealed.

Estates and Trusts §4-510: Persons required to make reasonable search for documents of potential donor.

Estates and Trusts §4-511: Delivery of document of gift.

Estates and Trusts §4-512: Referrals to procurement organizations.

Estates and Trusts §4-513: Prohibited acts.

Estates and Trusts §4-514: No liability for persons acting in good faith.

Estates and Trusts §4-515: Validity of document of gift.

Estates and Trusts §4-516: Donor registry requirements.

Estates and Trusts §4-517: Advance health care directives.

Estates and Trusts §4-518: Cooperation between Office of the Chief Medical Examiner and procurement organizations.

Estates and Trusts §4-518: Protocols and procedures for anatomical gifts.

Estates and Trusts §4-520: Application and construction of subtitle.

Estates and Trusts §4-521: Construction of subtitle with Electronic Signatures in Global and National Commerce Act.

Estates and Trusts §4-522: Short title.

Drugs

Health General §21-223: Approved applications required to sell, give away, or deliver new drugs.