The House of Representatives past a new bill last week that will expedite funding for the National Institute of Health (NIH) as well as approvals for the Federal Drug Administration (FDA). Known as the 21st Century Cures Act, it focuses around healthcare in the US. But both proponents and critics of the bill are speaking out about it and its impact on the Health Insurance Portability and Accountability Act (HIPAA) of 1996.
In addition to expediting NIH funding and FDA approval, the 21st Century Cures Act will allow the use of Protected Health Information (PHI) by covered entities for research purposes. This is in stark contrast to current HIPAA laws, which require doctors, physicians and other covered entities to obtain the patient's permission before his or her data can be used for research.
So, how does the 21st Century Cures Act define “research purposes?” The bill's sponsors note that research involves a systematic investigation, testing and evaluation that's intended to contribute to general knowledge. I guess you could say that's a catch-all term to cover a broad range of research purposes.
Proponents of the 21st Century Cures Act believe it will strengthen the US healthcare industry by breaking down barriers that are currently slowing the development of new drugs, vaccines and treatment options. With covered entities now receiving the green light to use PHI for research purposes, they'll have an easier time developing breakthrough new treatments.
Of course, proponents of the bill argue that the 21st Century Cures Act is nothing more than a violation of patients' privacy. HIPAA was created with the primary purpose of protecting the privacy of healthcare patients. If covered entities are allowed to use and share this data without the patient's permission, it could end up the wrong hands.
SEC 1443 (b) states the following:
“Permitted uses and disclosures.—The Secretary shall revise or clarify the Rule so that research activities, including comparative research activities, related to the quality, safety, or effectiveness of a product or activity that is regulated by the Food and Drug Administration are included as public health activities for purposes of which a covered entity may disclose protected health information to a person described in section 164.512(b)(1)(iii) of part 164”
You can read the 21st Century Cures Act by visiting https://www.congress.gov/bill/114th-congress/house-bill/2549/text.