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ARPA-H Passed the House of Representatives, now onto the Senate

By a bipartisan vote of 336 to 85, the House of Representatives passed an amended version of ARPA-H Act on June 22 and will now go to the Senate for their consideration. Congressional authorization of ARPA-H will allow people working in the biomedical industry, more specifically involving diseases affecting Americans, another federal funding source for research. A more comprehensive summary of the bill is to follow in the next Washington Download.

EHI Task Force Wraps Up Project

After two years of development, the EHI Task Force comprised of AMIA, AHIMA, and EHRA have finalized their report examining the relationship between specific aspects of the ONC Cures Act Final Rule and the definitions of the DRS and EHI. The report outlines key considerations that stakeholders should consider when operationalizing these concepts. The report also includes the Task Force’s review of data classes commonly maintained in health IT and the DRS against the definition of EHI, an analysis that helped frame development of the key considerations and recommendations.

Administration

OCR Clarifies Privacy Rule Following Supreme Court Ruling

The Department of Health & Human Services (HHS) Office for Civil Rights (OCR) sent out guidance June 29 to reinforce the Privacy Rule and disclosures when it comes to reproductive health care. The agency wants to be sure that there is a clear understanding that PHI related to reproductive health care is protected under HIPAA.

ONC Hosting EHI Sharing Workshop August 4

ONC is hosting a meeting for healthcare providers to discuss potential opportunities and challenges surrounding the sharing of EHI. ONC’s goal is to present tactics and lessons learned related to what, when and where EHI is handled for transmission. Register here.

NIH Calls for Comments Regarding Promoting Global Health Equity

The NIH is seeking response from biomedical workers on expertise to promote greater equity in global health research. NIH wants to know some of the current challenges and barriers to equitable research so that this could in turn engage with scientists in low and middle-income countries. RFI submissions must be sent to NIH by August 1.

FDA Requests for Nominations for Multiple Advisory Committees

FDA sent out a request for nominations on 29 different advisory committees that could present an opportunity for AMIA members to effect meaningful policy change. Some of the committees include FDA Science Board Advisory Committee Notice, Non-Prescription Drugs Advisory Committee, General Hospital and Personal Use Devices Panel, and Immunology Devices Panel.

Reminder: GAO Seeks Nominees for HITAC

The U.S. Government Accountability Office (GAO) is currently seeking nominations for the Health Information Technology Advisory Committee (HITAC). HITAC provides recommendations to the National Coordinator for Health Information Technology on policies, standards, implementation specifications, and certification criteria relating to the implementation of a health information technology infrastructure that advances the electronic access, exchange, and use of health information. Nominations are due July 22. For details, click here. If interested in receiving a recommendation from AMIA, or for more information on these opportunities, please contact Peter Mihalick, AMIA Vice President of Public Policy, pmihalick@amia.org.

Reminder: ONC Announces 2022 LEAP Funding Opportunity

ONC recently announced a funding opportunity for Leading Edge Acceleration Projects (LEAP) in Health IT. Click here for details.

Legislation & Politics

House Committee Seeking to Increase Diversity in NIH Clinical Trials

The House Energy & Commerce Committee Health Subcommittee discussed multiple pieces of legislation on June 29 that would work to increase diversity for participants in clinical trials funded by the NIH. One of the major bills, H.R. 7845 – “NIH Clinical Trial Diversity Act of 2022”, would create requirements for those seeking funding from NIH such as goals for recruitment and retention of participants, plans to achieve those goals, along with education and training for the researchers on diversity and health equity. The legislation would spend $10 million each year through 2027 to create a public awareness campaign to educate people about participating in clinical research.

American Data Privacy and Protection Act Introduced June 21

Sponsored by Rep. Pallone, H.R. 8152 – “To provide consumers with foundational data privacy rights, create strong oversight mechanisms, and establish meaningful enforcement” was introduced on June 21 with bipartisan sponsorship. The bill passed through the Subcommittee on Consumer Protection and Commerce of the House Committee on Energy and Commerce on the June 23 with markups and will move to the full committee in the coming weeks for consideration. This isn’t like PHI with HIPAA, but H.R. 8152 would set a broader standard for data privacy and potentially become the first federal privacy law.

Around the Web


AMIA’s Washington Download is your source for health informatics policy news and information from around the Beltway, covering action from the Hill, the Administration and important AMIA collaborators.