Department of Health and Human Services November 17, 2020 – Federal Register Recent Federal Regulation Documents

The Office of the Assistant Secretary for Health (OASH) in the Department of Health and Human Services, in partnership with other federal agencies, seeks to gain a more comprehensive understanding from health systems, community based organizations, academic institutions, non-federal government agencies, innovators, entrepreneurs, non-profit organizations, and other relevant stakeholders regarding innovative solutions to chronic disease management leveraging novel technologies (e.g., artificial intelligence (AI), biosensors, apps, remote monitoring, 5G) to optimize compliance with evidence-based standards of care in disease states that cause significant morbidity and mortality in aging populations in underserved areas (e.g., low income, Medicaid- eligible, rural). OASH will review information collected in this request for information (RFI) to better inform federal government priorities and programs. We also seek to identify opportunities to strengthen the U.S. healthcare system, as a whole, through public- private partnerships in data sharing, comprehensive analytics including AI, and other potential mechanisms. OASH welcomes public feedback related to how these questions should be addressed and/or potential solutions. The set of questions is available in the SUPPLEMENTARY INFORMATION section below.

The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ``Electromagnetic Compatibility (EMC) of Medical Devices.'' FDA has developed this guidance document to describe relevant information that should be provided in a premarket submission (i.e., premarket approval application (PMA), humanitarian device exemption (HDE), premarket notification (510(k)) submission, investigational device exemption (IDE), and De Novo request) to support a claim of electromagnetic compatibility for electrically powered medical devices and medical devices with electrical or electronic functions. This draft guidance is not intended to change current policy, but to provide specific technical information to address the recommendations originally described in the guidance entitled ``Information to Support a Claim of Electromagnetic Compatibility (EMC) of Electrically-Powered Medical Devices'' published July 11, 2016 (2016 EMC guidance). This draft guidance is not final nor is it in effect at this time.

The Administration for Community Living is announcing that the proposed collection of information listed above has been submitted to the Office of Management and Budget (OMB) for review and clearance as required under section 506(c)(2)(A) of the Paperwork Reduction Act of 1995. This 30-Day notice collects comments on the information collection requirements related to the proposed extension for the information collection requirements related to the NIDILRR Grantee Annual Performance Reporting (APR) and Final Report Forms.

The Health Information Technology Advisory Committee (HITAC) was established in accordance with the 21st Century Cures Act and the Federal Advisory Committee Act. The HITAC, among other things, identifies priorities for standards adoption and makes recommendations to the National Coordinator for Health Information Technology (National Coordinator). The HITAC will hold public meetings throughout 2021. See list of public meetings below.