ive DSI, ONC sets forth a number of other proposals, including:Other new and revised Certification Program criteria, including some that may intersect with other requirements, such as regulation by FDA, OCR (HIPAA), and the Federal Trade Commission (Section 5 of the FTC Act and the HBNR).New and revised Certification Program standards (including adoption of USCDI v3).Information Blocking Rule changes, such as new definitions of what it means to “Offer Health IT” and be a “Health IT Developer of Certified Health IT,” and modifications to the information blocking exceptions.Next Steps and Deadline for CommentsAffected entities should assess carefully the potential implications of the proposals ONC has set forth and consider providing input on the specific questions ONC has raised. Comments on Proposed Rule HTI-1 may be submitted until 5 p.m. ET on June 20, 2023. Health Data, Technology, and Interoperability: Certification Program Updates, Algorithm Transparency, and Information Sharing, 88 Fed. Reg. 23746 (proposed Apr. 18, 2023) (to be codified at 45 C.F.R. pts. 170, 171) [hereinafter Proposed Rule HTI-1].See, e.g., 21st Century Cures Act: Interoperability, Information Blocking, and the ONC Health IT Certification Program, 85 Fed. Reg. 25642 (May 1, 2020) (45 C.F.R. pts. 170, 171). See also U.S. Dept. Health & Hum. Servs. (HHS), Off. Nat’l Coordinator for Health Info. Tech. (ONC), About The ONC Health IT Certification Program, https://www.healthit.gov/topic/certification-ehrs/about-onc-health-it-certification-program (last modified Nov. 9, 2021).See, e.g., Ctrs. For Medicare & Medicaid Servs., Promoting Interoperability Programs, https://www.cms.gov/regulations-and-guidance/legislation/ehrincentiveprograms (last modified May 2, 2023). For a list of government and non-government programs that reference certified Health IT, see ONC, Programs Referencing ONC Certified Health IT, https://www.healthit.gov/topic/certification-ehrs/programs-referencing-onc-certified-health-it (last modified Mar. 27, 2019). ONC, Nati

two discussion papers on the use of AI and ML in drug development and manufacturing in May 2023. FDA, Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD) Action Plan (Jan. 2021), https://www.fda.gov/media/145022/download; FDA, Using Artificial Intelligence and Machine Learning in the Development of Drug and Biological Products (May 2023), https://www.fda.gov/media/167973/download; FDA, Artificial Intelligence in Drug Manufacturing (May 2023), https://www.fda.gov/media/165743/download. FDA also recently announced a new Digital Health Advisory Committee to help the agency explore issues related to digital health technologies (DHTs), including AI/ML. FDA, Digital Health Advisory Committee, https://www.fda.gov/medical-devices/digital-health-center-excellence/fda-digital-health-advisory-committee (last updated Oct. 13, 2023).3 Health Data, Technology, and Interoperability: Certification Program Updates, Algorithm Transparency, and Information Sharing, 88 Fed. Reg. 23746 (proposed Apr. 18, 2023) (to be codified at 45 C.F.R. pts. 170, 171).4 FDA, FDA Releases Two Discussion Papers to Spur Conversation about Artificial Intelligence and Machine Learning in Drug Development and Manufacturing (May 10, 2023), https://www.fda.gov/news-events/fda-voices/fda-releases-two-discussion-papers-spur-conversation-about-artificial-intelligence-and-machine.5 FDA, Artificial Intelligence and Machine Learning (AI/ML)-Enabled Medical Devices, https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-and-machine-learning-aiml-enabled-medical-devices (last updated Oct. 19, 2023).6 Specifically, these privacy regimes were adopted under the Health Insurance Portability and Accountability Act of 1996 (HIPAA), the Health Information Technology for Economic and Clinical Health Act of 2009 (HITECH), and Section 5 of the Federal Trade Commission Act (FTC Act).

ude paying lower damages than would normally be required, and avoiding costs and disruption associated with a government-directed investigation or litigation. The OIG also specifically noted that disclosure via the SDP and full cooperation with the OIG’s review and resolution of such a disclosure would be considered part of timely corrective action by an information blocking actor, which is a mitigating circumstance that the OIG will consider in determining the amount of a penalty.Enforcement to Begin September 1, 2023The OIG will begin enforcement starting September 1, 2023, 60 days after the final rule was published. While HIEs/HINs and Developers have already been required to comply with ONC’s information blocking rules, they now have 60 days to comply or be subject to penalties. Significantly, though, the OIG will not impose CMPs on information blocking conduct that occurred before September 1, 2023.*Daniel Shemano is a summer associate in the firm’s Century City office. FOOTNOTES 88 Fed. Reg. 23746 (Apr. 18, 2023).