Relates to allowing disclosure of confidential HIV related information for research purposes

Section 2 provides for an effective date 120 days after enactment.

Justification

The current law disadvantages HIV-positive patients because it creates a serious barrier to HIV/AIDS research by severely limiting the people who are permitted to review medical records of HIV-positive patients and extract data for scientific research. Unlike research related to other diseases, only individuals providing health care to individuals with HIV/AIDS are allowed to review the record and extract data; however, these care providers do not have time to extract data for research purposes. Thus, in many cases, research cannot be done because it is impossible to collect the necessary data. This bill will allow patients to experience the benefits that may accrue to them as research generates new knowledge about the disease. An illustration of the research that would benefit from access to the records is a comparison of the rates of liver cancer surveillance in patients receiving care from hepatologists versus other physicians. This work would allow researchers to determine whether these patients receive the same level of care for liver disease as HIV-negative patients with liver disease. Many HIV-positive patients with liver disease receive most of their care from infectious disease specialists and primary care physicians. It would benefit HIV-positive patients to have a high impact study demonstrating whether their physicians are adhering to guidelines about liver disease management. A comparison of rates of referral for liver transplantation evaluation in HIV-positive versus HIV-negative patients could demonstrate whether these patients are being given equal access to liver transplantation, a life saving procedure, or if their providers are failing to refer them for liver transplantation evaluation in a timely manner.

Expanded access to confidential AIDS records would allow researchers to learn more about how AIDS interacts with many medical conditions and will promote increased precision in the treatment of AIDS patients, a goal consistent with the 2015 Blueprint to End the Epidemic issued by the Department of Health (DOH).

Among other actions, the 2015 Blueprint recommends that the DOH expand the use of existing AIDS data. Although AIDS information is routinely collected in New York, it is not always used to better understand the AIDS epidemic, to improve patient outcomes, or to prevent new infections This proposal directly addresses this Blueprint recommendation, as data will be more thoroughly used for research that

could help better understand AIDS and eventually improve patient outcomes.

In order to maintain confidentiality, research access would be through and Institutional Review Board (IRB) established under state or federal law. IRBs have the authority to approve human subject research subject to regulations issued by Secretary of Health and Human Services and the Food and Drug Administration (FDA). In order to approve research, an IRB must determine that specified criteria have been satisfied, including the presence of adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data.

New York law also protects human subjects in medical research projects not otherwise subject to federal law through requiring public and private institutions and agencies engaging in human subject research to create human research review committees. Current New York law does not permit disclosure of information about HIV/AIDS disease to qualified researchers approved either by an IRB or a human research review committees. Only direct providers of health care are permitted to review such medical records and extract data for scientific research.

Although HIV/AIDS related information is treated very restrictively under the public health law recent amendments to the statute reflect a trend to de-stigmatize the disease in certain provisions of the law which simplify the HIV counseling and the testing process, regularizing them so that they are more like routine testing for other diseases. This bill is consistent with that trend of treating HIV/AIDS like other diseases by permitting qualified researchers to conduct approved medical research in much the same way as is done for other diseases.

Legislative history

New Bill

Fiscal implications

None

Effective date

120 days after the date on which the bill becomes law