The US Executive Branch’s  Spring 2019 Unified Agenda of Regulatory and Deregulatory Actions is out, and HHS/FDA have identified for deregulation, among other things, the current IRB approval process in order to allow any U.S. clinical site to rely on the approval of just one IRB in order to conduct a study at that site.  All proposed rule changes were made by the agency in response to the Administration’s request for all agencies to identify “ineffective regulations” and propose deregulations to meet the Administration’s objectives to streamline and improve “cost effectiveness” (although it is not clear whether it is HHS that would see economic benefit).  

Institutional Review Board Proposals

• Title: Institutional Review Boards; Cooperative Research 
  • Abstract: This proposed rule would replace current FDA requirements for cooperative research such that any institution located in the United States (U.S.) participating in multisite cooperative research would need to rely on approval by a single Institutional Review Board (IRB) for that portion of the research that is conducted in the U.S., with some exceptions.  This proposed rule would also establish an IRB recordkeeping requirement for research that takes place at an institution in which IRB oversight is conducted by an IRB that is not operated by the institution.

• Title: Institutional Review Board Waiver or Alteration of Informed Consent for Minimal Risk Clinical Investigations
  • Abstract: This proposed regulation would permit an Institutional Review Board (IRB) to waive or alter the informed consent requirements under certain conditions for minimal risk clinical investigations. This would facilitate certain minimal risk clinical investigations to support the development of new products to diagnose or treat disease and would harmonize with the HHS Common Rule waiver provision that has been adopted and successfully employed by other agencies. This proposed regulation is intended to aid patient access to new products by facilitating investigators’ ability to conduct studies that may contribute substantially to the development of products to diagnose or treat diseases or conditions, or address unmet medical needs.

Health Insurance Portability and Accountability Act of 1996 (HIPPA) Proposals

Also proposed is the “removal of barriers” created by HIPAA compliance, which is especially interesting in light of the fact that, in 2018, the Office of Civil Rights set an agency record in HIPAA enforcement activity by levying fines totaling $28.7 million (against MD Anderson, Boston Medical Center and Brigham’s and Women’s Hospital and MGH, among others).   All proposed rule changes were made by the agency in response to the Administration’s request for all agencies to identify “ineffective regulations” and propose deregulations to meet the Administration’s objectives to streamline and improve “cost effectiveness” (although it is not clear whether it is HHS that would see economic benefit).

• Title: HIPAA Privacy; Changes to Support, and Remove Barriers to, Coordinated Care
  • Abstract: This proposed rule would publish for comment proposals to modify provisions of the HIPAA Rules which present barriers that limit or discourage coordinated care and case management (including care coordination challenges arising from the opioid crisis) among hospitals, physicians (and other providers), payors, and patients, or otherwise impose regulatory burdens that may impede the transformation to value-based health care without providing commensurate privacy or security protections for patients’ protected health information (PHI) and while maintaining patients’ ability to control the use or disclosure of their PHI and to access PHI. This proposed rule would subsume the previous 0945-AA09 entry in the Regulatory Agenda.

• Title: HIPAA Enforcement Rule: Sharing Civil Money Penalties or Monetary Settlements With Harmed Individuals and Annual Penalty Limits
  • Abstract: This proposed rule would solicit the public’s views on proposals for the distribution of civil money penalty and monetary settlements with those harmed by a Health Insurance Portability and Accountability Act (HIPAA) offense and the annual limits on civil money penalties under the HITECH Act. 

Other HHS/FDA Proposals

The Office of Management and Budget’s Office of Information and Regulatory Affairs website has a synopsis of each regulation identified for “deregulation” by HHS/FDA, but the links to the meeting minutes for each proposal are inactive and the webpages with proposals under the Fall 2018 Unified Agenda are no longer active on the FDA website; it is not possible at this time to substantively review and compare the data (some of the HHS Spring 2019 proposals are updates to 2018 proposals) via the web.  Below is a list of changes we’ll be tracking as more information is made available as part of the public comment period:

• Title: Definition of the Term “Biological Product” 
  • Abstract: The Food and Drug Administration (FDA) proposes to amend its regulation that defines biological product to conform to the statutory definition (21 U.S.C. 262) adopted in the Biologics Price Competition and Innovation Act of 2009. 
• Title: ●HHS Policy for the Protection of Human Research Subjects: Update to Subpart E (IRB Registration) 
  • Abstract: This rule would amend subpart E of 45 CFR part 46 (Institutional Review Board (IRB) Registration) to align subpart E with recent amendments to the basic HHS Policy for the Protection of Human Subjects (subpart A of 45 CFR part 46, also known as the Common Rule) and to give effect to one of the policy goals of the subpart A revision (i.e., eliminating unnecessary administrative burden on IRBs and institutions regulated under 45 CFR part 46). The general compliance date of amendments to subpart A of 45 CFR part 46 was January 21, 2019.
• Title: Part 50 Protection of Human Subjects and Part 56 Institutional Review Boards
  • Abstract: This proposed rule would harmonize, to the extent practicable and consistent with other statutory provisions, several sections certain provisions of FDA’s regulations on human subject protection and institutional review boards with the recently revised “Federal Policy for the Protection of Human Subjects” (the revised Common Rule (45 CFR 46, subpart A)). The rule also proposes minor amendments to related regulatory provisions.
• Title: Updates to 1974 Privacy Act Regulations
  • Abstract: This rulemaking will update regulations at 45 CFR part 5b, which detail how the Department implements requirements of the Privacy Act of 1974, as amended (5 U.S.C. 552a).