Maryland Law
November 2004

Introduction:
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. These laws are a part of the Annotated Code of Maryland and are available to the public at the following website http://198.187.128.12/maryland/lpext.dll?f=templates&fn=fs-main.htm&2.0. 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

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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(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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(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.

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.

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.

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.

(d) Multiple specimens.-

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

(i) At least 1 positive test result is reported; and

(ii) The health officer has approved the reporting of less than all test results.

(2) The director of the medical laboratory need not report vibriosis, noncholera, 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 :

(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.

1. 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:

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.

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.

Abuse:

Family Law §5-704: Child Abuse and Neglect: Reporting of abuse or neglect

(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

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Family Law §5-705: Child Abuse and Neglect

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Family Law §5-705.1: Child Abuse and Neglect

Family Law §14-302: Adult Protective Services: Reporting abuse (vulnerable adults)

(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

(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 wh

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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(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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(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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(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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(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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(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;