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Maryland Law

November 2004

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.

Index

Research

  1. Health-General §13-2001 (Hubbard Bill): Human Subject Research: Definitions
  2. Health-General §13-2002 (Hubbard Bill): Human Subject Research: Compliance with federal regulations; scope
  3. Health-General §13-2003 (Hubbard Bill): Human Subject Research: Institutional review board minutes
  4. Health-General §13-2004 (Hubbard Bill): Human Subject Research: Injunctive or other relief for violations
  5. Health-General §18-201: Disease Prevention: Infectious or contagious disease reports - By physicians
  6. Health-General §18-201.1: Disease Prevention: AIDS reports - By physicians.
  7. Health-General §18-205: Disease Prevention: Laboratory examination reports

Clinical Practice

Guardianship and Decision-making

  1. Family Law §5-203: Definition of natural guardianship; custody
  2. Family Law §9.5-101(c):  Definition of “child”
  3. Health-General §5-605: Health Care Decisions Act: Surrogate decision making
  4. Health-General §20-102: Treatment for health-related problems

    Abuse

  5. Family Law §5-704: Child Abuse and Neglect: Reporting of abuse or neglect
  6. Family Law §5-705: Child Abuse and Neglect
  7. Family Law §5-705.1: Child Abuse and Neglect
  8. Family Law §14-302: Adult Protective Services: Reporting abuse (vulnerable adults)

    Privacy and Confidentiality

  9. Health-General §4-301: Confidentiality of Medical Records: Definitions
  10. Health-General §4-302: Confidentiality of Medical Records: Confidentiality and disclosure generally
  11. Health-General §4-303: Confidentiality of Medical Records: Disclosure upon authorization of a person in interest
  12. Health-General §4-304: Confidentiality of Medical Records: Copies of records; changes in records
  13. Health-General §4-305: Confidentiality of Medical Records: Disclosures without authorization of person in interest – in general
  14. Health-General §4-306: Confidentiality of Medical Records: Investigations
  15. Health-General §4-307: Confidentiality of Medical Records: Disclosure of mental health records
  16. Health-General §4-308: Confidentiality of Medical Records: Liability for good faith actions
  17. Health-General §4-309: Confidentiality of Medical Records: Refusal to disclose records; penalties
  18. Health-General §18-336: Disease Prevention: Specific Diseases: Testing
  19. Health-General §18-337: Disease Prevention

Organ and Tissue Donation

  1. Health-General §19-310: Organ and tissue donations
  2. Estates and Trusts §4-501: Maryland Anatomical Gift Act: Definitions
  3. Estates and Trusts §4-502: Maryland Anatomical Gift Act: Legislative Policy
  4. Estates and Trusts §4-503: Maryland Anatomical Gift Act: Execution of documents of anatomical gift
  5. Estates and Trusts §4-504: Maryland Anatomical Gift Act: Persons eligible to become donees of anatomical gifts
  6. Estates and Trusts §4-505: Maryland Anatomical Gift Act: Methods of making anatomical gifts.
  7. Estates and Trusts §4-506: Maryland Anatomical Gift Act: Delivery of will or document of gift to donee.
  8. Estates and Trusts §4-507: Maryland Anatomical Gift Act: Revocation of gift.
  9. Estates and Trusts §4-508: Maryland Anatomical Gift Act: Rights of next of kin and donee; time of death; civil or criminal liability; autopsies.
  10. Estates and Trusts §4-509: Maryland Anatomical Gift Act: When organ or tissue may be provided for transplant.
  11. Estates and Trusts §4-509.1: Maryland Anatomical Gift Act: When cornea may be provided for transplant.
  12. Estates and Trusts §4-510: Maryland Anatomical Gift Act: Gifts completed during lifetime of donor.
  13. Estates and Trusts §4-511: Maryland Anatomical Gift Act: Validity of authority or instrument executed prior to July 1, 1968.
  14. Estates and Trusts §4-512: Maryland Anatomical Gift Act: Short title.

Drugs

  1. Health-General §21-223: New Drugs – In general

Research

Health – General § 13-2001: Human Subject Research: Definitions

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

(b) Federal regulations on the protection of human subjects.- "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.

(c) Human Subject.- "Human subject" has the meaning stated in the federal regulations on the protection of human subjects.

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

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

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Health – General § 13-2002: Human Subject Research: Compliance with federal regulations; scope

 (a) Compliance with federal regulations.- 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.

(b) Scope to include all research.- 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: Human Subject Research: Institutional review board minutes

(a) Availability.- 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.

(b) Redaction of confidential or privileged information.- 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.

(c) Minutes not public records.- The minutes of a meeting of an institutional review board are not public records under Title 10, Subtitle 6 of the State Government Article.

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Health – General § 13-2004: Human Subject Research: Injunctive or other relief for violations

(a) In general.- 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.

(b) Exceptions.- 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: Disease Prevention: Infectious or contagious disease reports - By physicians

(a) Report required.- A physician with reason to suspect that a patient under the physician's care has an infectious or contagious disease except human immunodeficiency virus or acquired immunodeficiency syndrome that endangers public health shall submit immediately a report to the health officer for the county where the physician cares for that patient.

(b) Form and contents.- The report shall:

(1) Be on the form that the Secretary provides;

(2) Identify the disease or suspected disease;

(3) State the name, age, race, sex, and residence address of the patient; and

(4) Be signed by the physician.

(c) Confidentiality; when report subject to subpoena; applicability to disclosures by Secretary to other governmental agencies.-

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

(i) Confidential;

(ii) Not open to public inspection; and

(iii) Subject to subpoena or discovery in any criminal or civil proceeding only pursuant to a court order sealing the court record.

(2) 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: Disease Prevention: AIDS reports - By physicians.

(a) Report required.- A physician who has diagnosed a patient under the physician's care with 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.

(b) Form and content.- 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.

(c) Confidentiality; disclosure by secretary.-

(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) 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: Disease Prevention: Laboratory examination reports

(a) Invasive disease.- In this section, "invasive disease" means a disease in which an organism is detected in a specimen taken from a normally sterile body site.

(b) Report required.-

 (1) 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 within 48 hours after an examination of a human specimen shows evidence of any disease or condition listed in subsection (c) of this section.

(2) 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 within 48 hours after an examination of that specimen shows evidence of any disease or condition listed in subsection (c) of this section.

(c) List of reportable diseases or conditions.- The diseases or conditions reportable by a medical laboratory director under this section are:

(1) Amoebiasis.

(34) Meningitis, infectious.

(2) Anthrax.

(35) Microsporidiosis.

(3) Arbovirus infection (all types).

(36) Mumps.

(4) Bacteremia in newborns.

(37) Pertussis.

(5) Botulism.

(38) Pesticide related illness.

(6) Brucellosis.

(39) Plague.

(7) Campylobacter infection.

(40) Poliomyelitis.

(8) CD 4+ count, if less than 200/MM3.

(41) Psittacosis.

(9) Chlamydia infection.

(42) Q fever.

(10) Cholera.

(43) Rabies.

(11) Coccidioidomycosis.

(44) Ricin toxin.

(12) Cryptosporidiosis.

(45) Rocky Mountain spotted fever.

(13) Cyclosporiasis.

(46) Rubella and congenital rubella syndrome.

(14) Dengue fever.

(47) Salmonellosis (nontyphoid fever types).

(15) Diphtheria.

(48) Severe acute respiratory syndrome.

(16) Ehrlichiosis.

(49) Shiga-like toxin production.

(17) Encephalitis, infectious.

(50) Shigellosis.

(18) E. Coli 0157:H7 infection.

(51) Smallpox and other orthopox viruses.

(19) Giardiasis.

(52) Staphylococcal enterotoxin.

(20) Gonorrhea.

(53) Streptococcal invasive disease, group A.

(21) Haemophilus influenzae, invasive disease.

(54) Streptococcal invasive disease, group B.

(22) Hansen disease (leprosy).

(55) Streptococcus pneumoniae, invasive disease.

(23) Hantavirus infection.

(56) Syphilis.

(24) Hepatitis, viral, types A, B, C, and other types.

(57) Trichinosis.

(25) Human immunodeficiency virus infection.

(58) Tuberculosis.

(26) Isosporiasis.

(59) Tularemia.

(27) Legionellosis.

(60) Typhoid fever.

(28) Leptospirosis.

(61) Varicella (chickenpox), fatal cases only.

(29) Listeriosis.

(62) Vibriosis, noncholera.

(30) Lyme disease.

(63) Viral hemorrhagic fevers (all types).

(31) Malaria.

(64) Yellow fever.

(32) Measles.

(65) Yersiniosis.

(33) Meningococcal invasive disease.



 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 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, under subsection (c)(62) of this section if the disease is found in a specimen obtained from the patient's teeth, gingival tissues, or oral mucosa.

(e) Form and contents.- The report shall:

(1) Be either in the form that the Department prescribes or on the form that the Department provides; and

(2) State at a minimum:

(i) The date, type, and result of the test that shows evidence of a disease required to be reported;

(ii) 1. Except as provided in item 2 of this item, the name, age, sex, and residence address of the patient from whom the specimen was taken; and

2. For reports of human immunodeficiency virus infection and CD 4+ count under 200/MM3, the unique patient identifying number, age, sex, and zip code of residence of the patient; and

(iii) The name and address of the physician who requested the test.

(f) Reports by physicians.- This section does not relieve an attending physician of the duty to report under § 18-201 of this subtitle.

(g) Report to Secretary.-

(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.

(h) Communications with patients.- The Secretary, a health officer, or an agent of the Secretary or health officer may discuss a laboratory report with the attending physician, but, if the physician is reasonably available, may communicate with a patient only with the consent of the attending physician.

(i) Confidentiality; when report subject to subpoena; applicability to disclosures by Secretary to other governmental agencies.-

(1) All laboratory reports required under this section are:

(i) Confidential;

(ii) Not open to public inspection; and

(iii) Subject to subpoena or discovery in a criminal or civil proceeding only pursuant to a court order sealing the court record.

(2) 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.

(j) Inspection of laboratory records.- 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.

(k) List of names.-

(1) Except as provided in paragraph (2) of this subsection, a director of a medical laboratory, the Secretary, a health officer, or an agent of the director, Secretary, or health officer may compile or distribute a reproducible list of any of the names of patients that are in reports required under this section.

(2) A director of a medical laboratory, the Secretary, a health officer, or an agent of the director, Secretary, or health officer may not compile or distribute a reproducible list of any of the names of patients in reports relating to human immunodeficiency virus infection or CD 4+ count, if less than 200/MM3.

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Clinical Practice

Guardianship and Decision-making :

Family Law §5-203: Definition of natural guardianship; custody

(a) Natural guardianship.-

(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.

(b) Powers and duties of parents.- The parents of a minor child, as defined in Article 1, Section 24 of the Code:

(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.

(c) Support obligations of grandparents.- 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.

(d) Award of custody to parent.-

(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(c):  Definition of “child”

(c) Child -  "Child" means an individual under the age of 18 years.

Health-General §5-605: Health Care Decisions Act: Surrogate decision making

Surrogate authorization.-

(1) In this subsection, "unavailable" means:

(i) After reasonable inquiry, a health care provider is unaware of the existence of a surrogate decision maker;

(ii) After reasonable inquiry, a health care provider cannot ascertain the whereabouts of a surrogate decision maker;

(iii) A 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;

(iv) A surrogate decision maker is incapacitated; or

(v) A surrogate decision maker is unwilling to make decisions concerning health care for the individual.

(2) 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. 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;

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

Dispute among surrogates.-

(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.

(c) Standards for surrogates.-

(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.

(d) Exclusions.- A surrogate may not authorize:

(1) Sterilization; or

(2) Treatment for a mental disorder.

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Health-General §20-102: Treatment for health-related problems

(a) Minor who is married or parent.- A minor has the same capacity as an adult to consent to medical treatment if the minor:

(1) Is married; or

(2) Is the parent of a child.

(b) Emergency treatment.- 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.

(c) Consent for specific treatment.- A minor has the same capacity as an adult to consent t

(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; and

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

(c-1) Capacity to refuse treatment.- 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 alcohol or drug abuse treatment program certified under Title 8 of this article for which a parent or guardian has given consent.

(d) Consent to psychological treatment.- 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.

(e) Liabilities.- A physician, psychologist, or an individual under the direction of a physician or psychologist 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.

(f) Disclosure.- Without the consent of or over the express objection of a minor, the attending physician, psychologist or, on advice or direction of the attending physician or psychologist, a member of the medical staff of a hospital or public clinic 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: Child Abuse and Neglect: Reporting of abuse or neglect

(a) In general.- 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) (i) who has reason to believe that a child has been subjected to abuse, shall notify the local department or the appropriate law enforcement agency; or

(ii) who has reason to believe that a child has been subjected to neglect, shall notify the local department; 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.

(b) Oral and written reports; cooperation among departments and agencies.-

(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:

1. to the local department or appropriate law enforcement agency if the person has reason to believe that the child has been subjected to abuse; or

2. to the local department if the person has reason to believe that the child has been subjected to neglect; 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 if the individual has reason to believe that the child has been subjected to abuse.

(2) (i) An agency to which an oral report of suspected abuse 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.

(c) Contents of report.- 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: Child Abuse and Neglect

(a) In general.-
 
(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:

(i) if the person has reason to believe the child has been subjected to abuse, notify the local department or the appropriate law enforcement agency; or

(ii) if the person has reason to believe the child has been subjected to neglect, notify the local department.

(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.

(b) Notification of other agency; cooperative agreements.-

(1) An agency to which a report of suspected abuse 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.

(c) Form of report.- A report made under subsection (a) of this section may be oral or in writing.

(d) Contents of report.-

(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: Child Abuse and Neglect

(a) Local department, defined.- In this section, "local department" means a department of social services for a county in this State.

(b) Applicability.- 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.

(c) Form of Report.-

(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.

(d) Forwarding of Report.- 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: Adult Protective Services: Reporting abuse (vulnerable adults)

(a) Mandatory reporting by health practitioner, police officer, or human service worker.- 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:

(1) notify the local department; and

(2) 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.

(b) Manner of mandatory reporting.- 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.

(c) Reporting by others.- 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.

(d) Contents of report.- 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: Confidentiality of Medical Records: Definitions

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

Directory information.-

(1) "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.

(2) "Directory information" does not include health care information developed primarily in connection with mental health services.

(c) Disclose or disclosure.- "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.

(d) Emergency.- "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.

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

(f) Health care.- "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.

(g) Medical Record.-

(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(b)(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 when:

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.

(h) Health care provider.-

(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(e) of this article, a hospital as defined in § 19-301(g) of this article, a related institution as defined in § 19-301(o) of this article, a health maintenance organization as defined in § 19-701(f) 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.

(i) Mental health services.-

(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 or Title 12 of this article.

(j) Patient.- "Patient" means a person who receives health care and on whom a medical record is maintained.

(k) Person in interest.- "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 paragraph (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 paragraph (1), (2), (3), ( 4), or (5) of this subsection.

(l) Primary provider of mental health services.- "Primary provider of mental health services" means the designated mental health services provider wh

(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.

(m) Recipient.- "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: Confidentiality and disclosure generally

(a) In general.- 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.

(b) Applicability of subtitle.- 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 Title 4, Subtitle 5 and Title 14, 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 CFR 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.

(c) Directory information.- A health care provider may disclose directory information about a patient without the authorization of a person in interest, except if the patient has instructed the health care provider in writing not to disclose directory information.

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

(1) Authorized by the person in interest;

(2) Otherwise permitted by this subtitle;

(3) Permitted under Article 88A, § 6(b) of the Code; or

(4) Directory information.

(e) Transfer of records relating to transfer of ownership of health care practice or facility.-

(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.

(f) Construction of subtitle.- 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: Confidentiality of Medical Records: Disclosure upon authorization of a person in interest

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

(b) Form, terms and conditions of authorization.- Except as otherwise provided in subsection (c) 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.

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

(d) Revocation of authorization.-

(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.

(e) Entries in records.- 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: Confidentiality of Medical Records: Copies of records; changes in records

(a) Requests for copies.-

(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.

(b) Changes in records.-

(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.

(c) Payment of copying costs.-

(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 the cost of copying:

(i) For State facilities regulated by the Department of Health and Mental Hygiene, as provided in § 10-621 of the State Government Article; or

(ii) For all other health care providers, the reasonable cost of providing the information requested.

(3) (i) Subject to the provisions of paragraph (4) of this subsection, 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 50 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. A preparation fee not to exceed $15 for medical record retrieval and preparation; and

2. The actual cost for postage and handling of the medical record.

(4) On or after July 1, 1995, the fees charged under paragraph (3) of this subsection may be adjusted annually for inflation in accordance with the Consumer Price Index.

(5) 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.

(d) Nonpayment of copying costs.- 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: Confidentiality of Medical Records: Disclosures without authorization of person in interest – in general

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

(b) Permitted disclosure.- 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 Title 19, Subtitle 13 of this article, including nonprofit health service plans, health maintenance organizations, fiscal intermediaries and carriers, the Department of Health and Mental Hygiene 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 1 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) Except if the patient has instructed the health care provider not to make the disclosure, or if the record has been developed primarily in connection with the provision of mental health services, to immediate family members of the patient or any other individual with whom the patient is known to have a close personal relationship, if made in accordance with good medical or other professional practice;

(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 of Health and Mental Hygiene 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; or

(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.

(c) Disclosure for coordination of services and record retention within Montgomery County Department of Health and Human Services.-

(1) The disclosure of medical records under subsection (b)(9) 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: Confidentiality of Medical Records: Investigations

(a) Compulsory process.- 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.

(b) Permitted disclosures.- 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 Article 88A, § 6 of the Code;

(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 § 19-308.2 or § 10-807 of this article;

(6) (i) 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 subpoena, summons, warrant, or court order contains a certification that:

1. A copy of the subpoena, summons, warrant, or court order has been served on the person whose records are sought by the party seeking the disclosure or production of the records; or

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

(ii) In accordance with a stipulation by a patient or person in interest; or

(iii) In accordance with a discovery request permitted by law to be made to a court, an administrative tribunal, or a party to a civil court, administrative, or health claims arbitration proceeding;

(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; or

(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.

(c) Requests; documentation.- When a disclosure is sought under this section:

(1) A written request for disclosure or written confirmation by the health care provider of an oral request that justifies the need for disclosure shall be inserted in the medical record of the patient or recipient; and

(2) Documentation of the disclosure shall be inserted in the medical record of the patient or recipient.

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Health-General §4-307: Confidentiality of Medical Records: Disclosure of mental health records

(a) Definitions.-

(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" means an organization approved by the Mental Hygiene Administration to manage mental health resources and services in a designated area or to a designated target population.

(4) "Director" means the Director of the Mental Hygiene 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.

(b) Governing provisions.- 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.

(c) Permitted disclosures generally.- 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.

(d) Personal notes.-

(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.

(e) Disclosure relating to psychological tests.-

(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.

(f) Disclosure relating to obtaining or continuing employment.- 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.

(g) Records relating to groups or families.- 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.

(h) Participants in plans of care service agencies.- 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 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 to participate in the client information system developed by the agency.

(i) Rate reviews, audits, health planning, licensures, approvals or accreditations of facilities.- 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.

(j) Health, safety, and protection of recipient or others.-

(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 wh

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.

(k) Transfer of recipient; protection of advocacy system; commitment proceedings; court orders, subpoenas, etc.; death of recipient.-

(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, t

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 service of compulsory process or a discovery request, 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 a court, an administrative tribunal, or a party to a civil court, administrative, or health claims arbitration proceeding, if:

1. The request for issuance of compulsory process or the request for discovery filed with the court or administrative tribunal and served on the health care provider is accompanied by a copy of a certificate directed to the recipient, the person in interest, or counsel for the recipient or the person in interest; and

2. The certificate:

A. Notifies the recipient or the person in interest that disclosure of the recipient's medical record is sought;

B. Notifies the recipient or the person in interest of the provisions of this subsection or any other provision of law on which the requesting party relies in seeking disclosure of the information;

C. Notifies the recipient or the person in interest of the procedure for filing a motion to quash or a motion for a protective order;

D. Is attached to a copy of the request for issuance of a compulsory process or request for discovery; and

E. Is mailed to the recipient, the person in interest, or counsel for the recipient or person in interest by certified mail, return receipt requested, on or before the date of filing the request for issuance of compulsory process or the request for discovery;

(vi) 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

(vii) In the event of the death of a recipient, to the office of the medical examiner as authorized under § 5-309 or § 10-714 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.

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Health-General §4-308: Confidentiality of Medical Records: Liability for good faith actions

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: Confidentiality of Medical Records: Refusal to disclose records; penalties

(a) Refusal to disclose records.- 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.

(b) Refusal to disclose because payment is owed.- 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.

(c) Violations of subtitle.- 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.

(d) Criminal penalties.- 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.

(e) Fraudulent obtaining of records; wrongful disclosure of records.-

(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.

(f) Civil penalties.- 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: Disease Prevention: Specific Diseases: Testing

(a) Definitions.-

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

(2) "HIV" means the human immunodeficiency virus that causes acquired immune deficiency syndrome.

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

(b) Consent required for testing; counseling.- 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:

(1) Obtain written informed consent from the individual on a uniform HIV informed consent form that the Department shall develop consistent with the requirements of the Department as established by regulations adopted by the Department; and

(2) Provide the individual with pretest counseling, including:

(i) Education about HIV infection and methods for preventing transmission;

(ii) Information about a physician's duty to warn; and

(iii) Assistance in accessing health care available to an individual who tests positive for the HIV infection.

(c) Refusal to consent.- Refusal to consent to the HIV antibody test or a positive test result may not be used as the sole basis by an institution or laboratory to deny services or treatment.

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

(e) Test results.- A physician or physician's designee who obtains a positive result from an HIV antibody 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 positive result;

(2) Provide the individual with a copy of the Department's publication describing available counseling services;

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

(4) Offer to assist in notifying the individual's sexual and needle-sharing partners; and

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

(f) Form for consent document.- The informed consent document shall be distinct and separate from all other consent forms.

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

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Health-General §18-337: Disease Prevention:

(a) Definition.- 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.

(b) Notice to others by health care providers.- If an individual informed of the individual's HIV positive status under § 18-336 of this title 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.

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

(1) Within a reasonable time; and

(2) To the extent feasible.

(d) Referrals to appropriate services.- 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.

(e) Liability of physician – Disclosure.- 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.

(f) Same – Nondisclosure.- 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.

(g) Liability of hospitals or other health care providers.- 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 t

(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: Organ and tissue donations

(a) Designated requestor.- In this section, "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.

(b) Suitability for organ donation- Recovery agency contacted.-

(1) 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.

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

(c) Suitability for organ donation- Determination.-

(1) 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.

(2) 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.

(3) 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 subsection (d) of this section, if applicable.

(d) Request for consent for anatomical donation.-

(1) Except as provided in subsection (j) of this section, 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, in the order of stated priority, 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.

(2) For the purposes of paragraph (1) of this subsection, the representative of the deceased individual is 1 of the following individuals listed in the following order of priority:

(i) A spouse, but, if not alive or not competent, then;

(ii) A son or daughter who is at least 18 years old, but, if not alive, competent, or immediately available, then;

(iii) A parent, but, if not alive, competent, or immediately available, then;

(iv) A brother or sister who is at least 18 years old, but, if not alive or not competent, then;

(v) A guardian;

(vi) A friend or other relative of the decedent, if the individual:

1. Is a competent individual; and

2. Presents an affidavit to the attending physician stating:

A. That the individual is a relative or close friend of the decedent; and

B. Specific facts and circumstances demonstrating that the individual maintained regular contact with the decedent sufficient to be familiar with the decedent's activities, health, and personal beliefs; or

(vii) Any other person authorized or required to dispose of the body.

(3) (i) This subsection does not apply if the decedent has given contrarydirections.

(ii) The failure of the decedent to make a gift is not a contrary direction for purposes of this subsection.

(4) Contrary directions given by the decedent under this subsection shall be recorded in the decedent's medical record.

(5) 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 § 4-508(b) of the Estates and Trusts Article.

(e) Agency representative to show discretion and sensibility.- 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:

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

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

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

(f) Documentation of request for organ donation and consent thereto.-

(1) When a representative of the appropriate organ, tissue, or eye recovery agency or a designated requestor makes a request under subsection (d)(1) of this section, the representative or designated requestor shall document the request and its disposition by having the appropriate individual described in subsection (d)(2) of this section sign a consent form or give a witnessed telegraphic, witnessed telephonic, or recorded consent to the donation.

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

(g) Entities not to be billed for organ donation costs.- A hospital may not bill the estate of the decedent, a surviving spouse 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.

(h) Organ donation guidelines.- After consultation with the Maryland Hospital Association, Inc., the Medical and Chirurgical Faculty of the State of Maryland, the Transplant Resource Center of Maryland, Inc., the Washington Regional Transplant Consortium, the Medical Eye Bank of Maryland, the Lions of District 22-C Eye Bank and Research Foundation, Incorporated, the Health Facilities Association of Maryland, and Tissue Banks International, the Secretary shall publish guidelines designed to implement this section, including guidelines:

(1) 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;

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

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

(i) Chief Medical Examiner.- The provisions of this section 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.

(j) Consent of the decedent’s representative not necessary.- The consent of the decedent's representative is not necessary and the provisions of subsection (d) of this section do not apply if:

(1) The decedent's driver's license or identification card contains a notation that the decedent is an organ donor; or

(2) The decedent has consented to the gift of all or any part of the decedent's body in accordance with the provisions of:

(i) § 5-604.1 of this article; or

(ii) Title 4, Subtitle 5 of the Estates and Trusts Article.

(k) Immunity from prosecution and liability.- 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.

(l) Annual death record reviews.- The Department shall conduct annual death record reviews at each hospital to determine the hospital's compliance with the provisions of this section. 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.

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Estates and Trusts §4-501: Maryland Anatomical Gift Act: Definitions

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

(b) Body or part of body.- "Body" or "part of body" includes organs, tissues, bones, blood, and other body fluids.

(c) Licensed hospital.- "Licensed hospital" includes any hospital licensed by the State Department of Health and Mental Hygiene under the laws of the State, and any hospital operated by the United States government, although not required to be licensed under the laws of the State.

(d) Next of kin.- "Next of kin" includes spouse.

(e) Person.- "Person" means any individual, corporation, government or governmental agency or subdivision, estate, trust, partnership or association, or any other legal entity.

(f) Physician or surgeon.- "Physician" or "surgeon" means any physician or surgeon licensed to practice under the laws of the State.

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Estates and Trusts §4-502: Maryland Anatomical Gift Act: Legislative Policy

(a) Legislative policy.- Because of the rapid medical progress in the field of tissue and organ preservation, the transplantation of tissue, and tissue culture, and because it is in the public interest to aid the development of this field of medicine, it is the policy and purpose of the General Assembly of Maryland in enacting this subtitle to encourage and aid the development of reconstructive medicine and surgery and the development of medical research by facilitating authorizations for premortem and postmortem donations of tissue and organs.

(b) Purpose of subtitle.- It is the purpose of this subtitle to regulate only the gift of a body or parts of a body to be made after the death of a donor.

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Estates and Trusts §4-503: Maryland Anatomical Gift Act: Execution of documents of anatomical gift

(a) Qualifications of donor; when gift takes effect.- Any individual who is 18 years of age or over and who is competent to execute a will may give all or any part of his body for any one or more of the purposes specified in this subtitle. The gift takes effect after death of the donor.

(b) Persons who may make gift.-

(1) If the decedent has not made a gift of all or part of the decedent's body for purposes of this subtitle, unless the person has knowledge that contrary directions have been given by the decedent, the following persons, in the order of priority stated, may give all or any part of a body of a decedent for any one or more of the purposes specified in this subtitle:

(i) The spouse, if one survives;

(ii) An adult son or daughter;

(iii) Either parent;

(iv) An adult brother or sister;

(v) The guardian of the person of the decedent at the time of his death;

(vi) A friend or other relative of the decedent, if the individual:

1. Is a competent individual; and

2. Presents an affidavit to the hospital stating:

A. That the individual is a relative or close friend of the decedent; and

B. Specific facts and circumstances demonstrating that the individual maintained regular contact with the decedent sufficient to be familiar with the decedent's activities, health, and personal beliefs; or

(vii) Any other person or agency authorized or under obligation to dispose of the body.

(2) If there is no surviving spouse and an adult son or daughter is not immediately available at the time of death of a decedent, the gift may be made by either parent. If a parent of decedent is not immediately available, the gift may be made by any adult brother or sister of decedent. If there is known to be a controversy within the class of persons first entitled to make the gift, the gift may not be accepted. The persons authorized by this subsection to make the gift may execute the document of gift either after death or during a terminal illness.

(c) Failure to make a gift.- The failure of the decedent to make a gift is not a contrary direction for purposes of this section.

(d) Method of making a gift.- If the gift is made by a person designated in § 4-503(b) of this section, it shall be by a document signed by him, by his telegraphic, recorded telephonic, or other recorded message, or by a witnessed telephonic statement.

(e) Examination for medical acceptance.- A gift of all or part of a body authorizes any examination of the body, or any other procedure, necessary to assure medical acceptability of the gift for the purposes intended. A person or entity required to make a determination of suitability under § 19-310 of the Health - General Article may examine the decedent and the decedent's medical records and conduct any inquiry necessary to determine suitability for donation.

(f) Rights of donee.- Except as provided in § 4-507 of this subtitle, the rights of the donee created by the gift are paramount to the rights of others.

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Estates and Trusts §4-504: Maryland Anatomical Gift Act: Persons eligible to become donees of anatomical gifts

(a) In general.- The persons listed in this section are eligible to receive gifts of human bodies or parts of them for the purposes stated.

(b) Hospital, surgeon, or physician.-

(1) Any licensed hospital, surgeon, or physician may receive a gift for medical education, research, advancement of medical science, therapy, or transplantation to individuals.

(2) A licensed hospital, surgeon, or physician that receives a gift for the purpose of a transplantation may not bill the estate of the donor, a surviving spouse of the donor, any heirs of the donor, or an insurer of the donor for the costs associated with the removal of the gift.

(c) Medical school.- An accredited medical school, college, or university engaged in medical education or research may receive a gift for therapy, educational research, or medical science purposes.

(d) Storage of blood or human organs.- Any licensed person operating a bank or storage facility for blood, arteries, eyes, pituitaries, or other human parts may receive a gift for use in medical education, research, therapy, or transplantation to individuals.

(e) Specified donee.- Any specified donee may receive a gift for therapy or transplantation needed by him.

(f) Federally designated organ procurement organization.- The federally designated organ procurement organization for the region in which the hospital is located may receive a gift for use in accordance with federal and State policies regarding organ allocation.

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Estates and Trusts §4-505: Maryland Anatomical Gift Act: Methods of making anatomical gifts.

(a) Gift by will.- A gift of all or part of the body for purposes of this subtitle may be made by will, in which case the gift becomes effective immediately upon death of the testator without waiting for probate. If the will is not probated, or if it is declared invalid for testamentary purposes, the gift, to the extent that it has been acted upon in good faith, is nevertheless valid and effective.

(b) Gift of document.- A gift of all or part of the body for purposes of this subtitle also may be made by document other than a will. The document must be signed by the donor in the presence of two witnesses, who, in turn, shall sign the document in the presence of the donor. If the donor cannot sign in person, the document may be signed for him, at his direction and in his presence, and in the presence of two witnesses, who, in turn, shall sign the document in the presence of the donor. Delivery of the document or gift during the lifetime of the donor is not necessary to make the gift valid. The document may consist of a properly executed card carried on the person of the donor or in his effects. The document and card may conform substantially to the following form:

ANATOMICAL GIFT BY A LIVING DONOR

I am at least 18 years of age and make this anatomical gift to take effect upon my death. The marks in the appropriate squares and words filled into the blanks below indicate my desires.

1. I give: my body; any needed organs or parts; the following organs or parts;

2. To the following person, agency, or institution: any person, tissue bank, or institution authorized by law; the Anatomy Board of Maryland;

 the following named physician, hospital, tissue bank or other medical institution;

3. For the following purposes: any purpose authorized by law;

transplantation; therapy; medical research and education.

Dated City and State

Signed by the Donor in the presence of the following who sign as witnesses:

Witness Signature of Donor

Witness Address of Donor

(c) Designation on driver’s license of gift of body.- A gift of all or part of the body for purposes of this subtitle also may be made by a designation on the donor's driver's license or identification card under § 12-303 of the Transportation Article.

(d) Manner of making and accepting gift of organ or body; immunities.- The gift may be made either to a named donee, or without the naming of a donee. If the latter, the gift of an organ for transplantation may be accepted by an organ procurement organization and utilized in accordance with federal and State policies regarding organ allocation. If the gift is tissue, the gift may be accepted by the organ procurement organization, tissue bank, or eye bank affiliated with the hospital and utilized at the organization's discretion and as required by law. The organ procurement organization, tissue bank, or eye bank possesses and may exercise all rights and is entitled to all immunities of the donee under this subtitle.

(e) Designation of surgeon to carry out procedures.- The donor may designate in his will or other document of gift the surgeon, physician, or technician to carry out the appropriate procedures. In the event the designee is not available, or in the absence of a designation, the donee or other person authorized to accept the gift may employ or authorize any licensed surgeon, licensed physician, or technician for the purpose.

(f) Validity of document of gift executed in another state.- A document of gift executed in another state and in accord with the laws of that state or executed in a territory or possession of the United States under the control and dominion of the federal government exclusively, and in accord with a federal law is valid as a document of gift within the state, even if the document does not substantially conform to the requirements of subsection (b) of this section.

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Estates and Trusts §4-506: Maryland Anatomical Gift Act: Delivery of will or document of gift to donee.

(a) Delivery to expedite procedure.- Immediately after death if the gift is made to a named donee, the will or other document or an attested true copy of it may be delivered to him to expedite the appropriate procedure, but delivery is not necessary to validate the gift.

(b) Production of will.- Upon request of the named donee or his agent after the death of the donor, the person in possession shall produce the will or other document of gift for examination.

Estates and Trusts §4-507: Maryland Anatomical Gift Act: Revocation of gift.

(a) Revocation of delivered document.- Any document of gift which has been delivered to the donee may be revoked by:

(1) The execution and delivery to the donee or his agent of a revocation in writing, signed by the donor;

(2) An oral statement of revocation witnessed by two persons, and communicated to the donee or his agent;

(3) A statement during a terminal illness addressed to the attending physician and communicated to the donee, or his agent; or

(4) A card or other writing signed by the donor and carried on his person or in his effects, revoking the gift.

(b) Revocation of undelivered document.- Any document of gift which has not been delivered to the donee may be revoked in the manner set out in subsection (a) of this section, or by destruction, cancellation, or mutilation of the document.

(c) Revocation of gift made by will.- Any gift made by a will may be revoked in the manner set out in subsection (a) of this section, or in the manner provided for revocation or amendment of wills.

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

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Estates and Trusts §4-508: Maryland Anatomical Gift Act: Rights of next of kin and donee; time of death; civil or criminal liability; autopsies.

(a) Acceptance or rejection of gift; custody of body of decedent; determining time of death.- The donee may accept or reject the gift. If the gift is only a part of the body, promptly following the removal of the part named, custody of the remaining parts of the body shall be transferred to the next of kin or other person or agency authorized or under obligation to dispose of the body. The time of death shall be determined by the physician in attendance upon the terminal illness of the donor or certifying his death, and the physician may not be a member of the team of physicians which transplants the part to another individual.

(b) No civil or criminal liability for unknowingly violating subtitle.- A person who, in good faith and acting in reliance upon an authorization made under the provisions of this subtitle or under the anatomical gift laws of another state or foreign country and without notice of revocation, takes possession of, performs surgical operations upon, or removes tissue, substances, or parts from the human body or refuses the gift, or a person who unknowingly fails to carry out the wishes of the donor according to the provisions of this subtitle or under the anatomical gift laws of another state or foreign country, is not subject to prosecution in any criminal proceedings or liable for damages in a civil action brought against him for the act or failure to act.

(c) Effect of laws concerning autopsies.- The provisions of this subtitle are subject to the laws prescribing powers and duties with respect to autopsies and are not in contravention of them

Estates and Trusts §4-509: Maryland Anatomical Gift Act: When organ or tissue may be provided for transplant.

(a) Requirements.- The Chief Medical Examiner, the deputy chief medical examiner, or an assistant medical examiner may provide an organ or tissue upon the request of the federally designated organ procurement organization or tissue bank under the following conditions:

(1) The medical examiner has charge of a decedent who may provide a suitable organ or tissue for transplant;

(2) A reasonable, unsuccessful search has been made by the treating physician and the hospital where the patient is located to contact the next of kin;

(3) No objection by the next of kin is known by the medical examiner; and

(4) The organ or tissue for transplant will not interfere with the subsequent course of an investigation or autopsy.

(b) Immunity from liability.-

(1) The Chief Medical Examiner, the deputy chief medical examiner, an assistant chief medical examiner, the organ procurement organization, and the tissue bank are not liable for civil action if the next of kin is located subsequently and contends that authorization of that kin was required, if the Chief Medical Examiner has obtained a written or verbal statement from the treating physician, organ procurement organization, tissue bank, or hospital where the decedent was located that a reasonable unsuccessful search was conducted for the next of kin prior to the removal of the organ or tissue for transplantation.

(2) A verbal statement under paragraph (1) of this subsection shall be documented in the decedent's medical record.

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Estates and Trusts §4-509.1: Maryland Anatomical Gift Act: When cornea may be provided for transplant.

(a) Requirements.- In any case where there is a need for corneal tissue for a transplant or research, the Chief Medical Examiner, the deputy chief medical examiner, or an assistant medical examiner shall provide the cornea upon the request of the Medical Eye Bank of Maryland, Incorporated, or the Lions of District 22-C Eye Bank and Research Foundation, Incorporated, subject to the provisions of subsection (b) of this section, and under the following conditions:

(1) The medical examiner has charge of a decedent who may provide a suitable cornea for the transplant or research;

(2) An autopsy will be required;

(3) No objection by the next of kin is known by the medical examiner;

(4) No religious objection made by the decedent before death is known by the medical examiner; and

(5) Removal of the cornea for transplant will not interfere with the subsequent course of an investigation or autopsy or alter the postmortem facial appearance.

(b) Distribution of corneal tissue.- Corneal tissue provided under subsection (a) of this section shall be distributed as follows:

(1) If the decedent died in Prince George's County, Montgomery County, Charles County, Calvert County, or St. Mary's County, the corneal tissue shall be distributed to the Lions of District 22-C Eye Bank and Research Foundation, Incorporated; or

(2) If the decedent died in any other county or in Baltimore City, the corneal tissue shall be distributed to the Medical Eye Bank of Maryland, Incorporated.

(c) Liability of medical examiner, Medical Eye Bank of Maryland, etc.- The Chief Medical Examiner, the deputy chief medical examiner, an assistant medical examiner, the Medical Eye Bank of Maryland, Incorporated, or the Lions of District 22-C Eye Bank and Research Foundation, Incorporated, are not liable for civil action if the next of kin subsequently contends that authorization of that kin was required.

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Estates and Trusts §4-510: Maryland Anatomical Gift Act: Gifts completed during lifetime of donor.

The provisions of this subtitle do not apply to gifts of parts of the body if the gifts are made during the lifetime of the donor with the intention that the part of the body is delivered to the donee during the lifetime of the donor.

Estates and Trusts §4-511: Maryland Anatomical Gift Act: Validity of authority or instrument executed prior to July 1, 1968.

Nothing in this subtitle invalidates any authority or instrument executed prior to July 1, 1968.

Estates and Trusts §4-512: Maryland Anatomical Gift Act: Short title.

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

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Drugs:

Health-General §21-223: New Drugs – In general

(a) Scope of section.- 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 Act of July 1, 1944 or under the Animal Virus, Serum, Toxin, Antitoxin Act of March 4, 1913.

(b) Prohibitions.- 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.

(c) Filing of application with Secretary.- 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.

(d) Standard for approval.- 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.

(e) Automatic approval of applications; procedure and grounds for disapproval.- 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.

(f) Order of disapproval.- 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.

(g) Revocation of disapproval; revocation of approval.-

(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.

(h) Records and reports.- 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.

(i) Rules, regulations, and orders about records and reports.-

(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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