HIPAA Privacy Rule changes that have the potential to significantly impact patients, covered entities, and business associates were proposed by the Department of Health and Human Services (HHS) in a Notice of Proposed Rulemaking (NPRM) on December 10, 2020. If these changes are adopted, it would reflect the largest regulatory change to HIPAA since the Omnibus HIPAA Final Rule. The future of these proposed modifications, however, is uncertain given the coming change in Administration. Many of the proposed changes are focused on the patient right of access requirements and processes, while others impact how covered entities may share patient information and how privacy practices must be documented.
These proposed regulations build upon earlier agency action, through the 21st Century Cures Act: Interoperability, Information Blocking, and the ONC Health IT Certification Program Final Rule and the CMS Interoperability and Patient Access final rule, in an effort to reduce barriers to access to patient records.
Key changes include:
Public comments will be due 60 days after the NPRM’s official publication in the Federal Register, which has not yet occurred. HHS has made an unofficial version of the NPRM available on its site pending the official publication. HHS has requested comments on several specific issues throughout the proposed rule. After comments on the NPRM are received and considered, HHS will publish a final rule that will establish the final requirements and timelines. HHS states that it believes that covered entities and business associates will be able to comply within 240 days of the official publication of a final rule, including revising policies and practices and completing training and implementation. Organizations that believe a longer compliance period will be needed to fully implement the required changes are encouraged to submit comments to the NPRM. The comment period will be only 60 days and so interested parties are encouraged to organize comments as soon as possible.
Authored by: Marcy Wilder, Melissa Bianchi, Scott Loughlin, Melissa Levine, Madeline Gitomer, Katherine Kwong.
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