Health Law Advisor

On August 5, 2024, the Office of the National Coordinator for Health Information Technology— now known as the Assistant Secretary for Technology Policy/Office of the National Coordinator for Health IT (“ASTP/ONC”) within the U.S. Department of Health and Human Services (“HHS”)—issued a proposed rule titled “Health Data, Technology, and Interoperability: Patient Engagement, Information Sharing, and Public Health Interoperability” (the “HTI-2 Proposed Rule”), as part of its ongoing efforts to enhance health care interoperability and data sharing. The HTI-2 Proposed Rule builds on the January 2024 “Health Data, Technology, and Interoperability” final rule (the “HTI-1 Final Rule”). Comments on the HTI-2 Proposed Rule are due October 4.

Through the proposed changes, ASTP/ONC would (1) make sweeping changes to its Health Information Technology Certification Program (“HIT Certification Program”); (2) make revisions to the information blocking regulation, including implementing two new information blocking exceptions; and (3) codify and implement the statutory provisions regarding the Trusted Exchange Framework and Common Agreement (“TEFCA”) requirements.

New and Revised HIT Certification Criteria

The proposed changes in the HTI-2 Proposed Rule would significantly expand the scope of the HIT Certification Program to introduce additional functionality and new technology for developers of HIT used by health care providers and HIT that is intended to be used by payers and for public health agencies. The certification criteria introduced in HTI-2 for payers is the first time that the health IT certification program is being extended beyond the certified electronic health record (EHR) technology developers. Some notable changes include the following:

This is the 7th and final installment in the Medicare Secondary Payer Compliance series. All titles in this series can be viewed below. Subscribe to our blog to receive these future updates. Prior installments of this series can be accessed using the links provided.

• Medicare Secondary Payer Compliance: An Introduction (Part I)
• Medicare Secondary Payer Compliance: Conditional Payments (Part II)
• Medicare Secondary Payer Compliance: Group Health Plans (Part III)
• Medicare Secondary Payer Compliance: Non-Group Health Plans (NGHPs) (Part IV)
• Medicare Secondary Payer Compliance:

The following may surprise some: FDA approval or clearance is never enough. Not if manufacturers want a commercially successful product. There is no doubt that addressing FDA issues is critical. But without data to show effectiveness, payers will not reimburse a particular product or technology—and even the most promising product will languish in the market without the appropriate coverage and reimbursement.

The use of remote monitoring devices has increased significantly over the last few years. I think it is fair to say that many manufacturers of these devices worry ...