1. A. This chapter establishes the requirements for:

   1. (1) Physician reporting of a:

      1. (a) Case of human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS); and
      2. (b) Birth of an infant whose mother has tested positive for HIV;
   2. (2) Institution reporting of a case of HIV or AIDS;

   3. (3) Laboratory reporting of a test result for:

      1. (a) HIV detection;
      2. (b) HIV viral load;
      3. (c) CD4+ cell count or percentage; or
      4. (d) HIV genotype sequence; and

   4. (4) Follow-up of:

      1. (a) A physician's report of HIV or AIDS;
      2. (b) A physician's report of an infant whose mother has tested positive for HIV;
      3. (c) An institution's report of HIV or AIDS; and

      4. (d) A laboratory’s report of a test result for:

         1. (i) HIV detection;
         2. (ii) HIV viral load;
         3. (iii) CD4+ cell count or percentage; or
         4. (iv) HIV genotype sequence infection or CD4+ count.

2. B. Except as noted in §C of this regulation, this chapter applies to all instances of laboratory testing of specimens from a human body for:

   1. (1) HIV detection;
   2. (2) HIV viral load;
   3. (3) CD4+ cell count or percentage; or
   4. (4) HIV genotype sequence.

3. C. This chapter does not apply if the specimen from a human body is:

   1. (1) Not tested for:

      1. (a) HIV detection;
      2. (b) HIV viral load;
      3. (c) CD4+ cell count or percentage; or
      4. (d) HIV genotype sequence;
   2. (2) Tested for HIV detection solely for the purpose of determining the suitability of the source individual as a prospective donor of blood, semen, or tissue;
   3. (3) Taken from a patient at a designated anonymous HIV test site solely for the purpose of performing an anonymous HIV test;

   4. (4) Tested for HIV detection as part of research conducted by an institution within Maryland under the following conditions:

      1. (a) All personal identifiers are removed from the specimen before testing;
      2. (b) The specimen cannot be linked to the individual from whom the specimen was taken;
      3. (c) The result cannot be linked to the individual from whom the specimen was taken; and
      4. (d) The research protocol has been approved by an institutional review board;
   5. (5) Tested for HIV detection as part of research conducted under a research protocol approved by an institutional review board of an institution located outside of Maryland;
   6. (6) Taken from a patient known to reside outside of the United States; or
   7. (7) Tested for HIV detection as part of a research project that has been approved under Regulation .02 of this chapter for an exemption.

Authority: Health-General Article, §§2-104(b), 4-101, 4-102, 18-102, 18-103, 18-201.1, 18-202.1, 18-205, 18-207, and 18-215;
State Government Article, §10-617; Annotated Code of Maryland

Effective date: February 18, 2002 (29:3 Md. R. 220)

Chapter revised effective September 8, 2008 (35:18 Md. R. 1600)

Regulation .01 amended effective May 18, 2020 (47:10 Md. R. 518

Regulation .02 amended effective May 18, 2020 (47:10 Md. R. 518)

Regulation .02B, C amended effective March 14, 2016 (43:5 Md. R. 385)

Regulation .03B amended effective March 14, 2016 (43:5 Md. R. 385); May 18, 2020 (47:10 Md. R. 518)

Regulation .06A amended effective May 18, 2020 (47:10 Md. R. 518)

Regulation .07 amended effective May 18, 2020 (47:10 Md. R. 518)

Regulation .08 amended effective May 18, 2020 (47:10 Md. R. 518)

Regulation .08C amended effective March 14, 2016 (43:5 Md. R. 385)

Regulation .09B amended effective May 18, 2020 (47:10 Md. R. 518)

Regulation .03B amended effective March 14, 2016 (43:5 Md. R. 385)