On February 28, 2025, Secretary Kennedy revoked the “Richardson Waiver,” and in doing so, stated that: “The policy waiving the statutory exemption for rules relating to public property, loans, grants, benefits, or contracts is contrary to the clear text of the APA and imposes on the Department obligations beyond the maximum procedural requirements specified in … Continue reading Secretary Kennedy’s Revocation of the Richardson Waiver
On December 27, 2024, the Department of Health and Human Services proposed a new HIPAA Security Rule (“the Proposed Rule”). The Proposed Rule is significant in scope, retains the current Security Rule’s requirements for “reasonable” safeguards while making many specific practices required visa-vi HIPAA’s implementation specifications, requires the implementation of several industry standard practices (e.g. … Continue reading The Proposed HIPAA Security Rule: The Good, the Bad, and What You Can Do
This post goes over two recent executive orders and what it means for health IT developers, as well as the impact of recent DOGE force reductions at HHS. First, the administration’s February 18, 2025, Ensuring Accountability for All Agencies Executive Order has the potential have serious impacts on the health IT community. In short, it … Continue reading New Executive Orders On Regulations and DOGE Force Reductions
Two weeks ago, the ONC/ASTP sent a memo to members of the HITAC Committee stating that meetings were suspended until further notice. You can read more about it at Fierce Healthcare at https://www.fiercehealthcare.com/health-tech/trump-administration-indefinitely-suspends-meetings-hhs-health-it-advisory-committee. This post looks at where the HITAC Committee came from, what it is supposed to do, and the HITAC Committee’s chances of … Continue reading HITAC Down: What’s Next?
The next Health Data, Technology, and Interoperability (“HTI) rule looks like it is coming in March. The Office of Management and Budget’s Office of Information and Regulation Affairs’ Unified Agenda, which is published at https://www.reginfo.gov/public/, has an indication on it that a fourth “HTI” rule will be published under the title “Health Data, Technology, and … Continue reading HTI-4 and What’s Next for HHS ASTP/ONC.
The Federal Trade Commission recently finalized its “Click-To-Cancel” or“Negative Option” rule. Commission Chair Lina M. Khan stated that “[t]oo often businesses make people jump through endless hoops just to cancel a subscription. The FTC’s rule will end these tricks and traps . . . [n]obody should be stuck paying for a service they no longer … Continue reading The Negative Option Rule: Does It Apply to EMRs and healthcare software?
Information blocking is any practice that could interfere with the access, exchange, or use of electronic health information (“EHI”) if done by a covered actor, which includes healthcare providers. This blog has discussed how 2016’s 21st Century Cures Act implemented a prohibition against information blocking, and HHS’s plans for its implementation. However, to-date healthcare providers … Continue reading Information Blocking Penalties for Doctors and Hospitals
Modernizing Medicine settled the allegations by the DOJ that it violated the Anti-kickback Statute in exchange for $45 million on November 1. US Attorney Nikolas Kerest, representing the District of Vermont, summarized the case in a press release, stating: “It is imperative that medical providers be able to trust the health record systems with which … Continue reading Modernizing Medicine Part 2: Kickbacks, EHR Donations, and Pathology Orders
The Department of Justice announced that it would intervene in a False Claims Act case brought by a relator on behalf of the United States against a certified electronic health record vendor, Modernizing Medicine. https://vermontbiz.com/news/2022/march/25/doj-joins-whistleblower-case-against-modernizing-medicine-and-co-founder In summary, the relator has alleged that Modernizing Medicine faked its product’s certification - which did not meet the certification … Continue reading Modernizing Medicine Part 1: Product Management Matters
While the 21st Century Cures Act’s prohibition against information blocking has been effective for well over a year for health IT developers and information exchanges, healthcare providers have not been held to civil monetary penalties, yet. That will change this Spring. The 21st Century Cures Act (“Cures”) requires healthcare providers to share electronic protected health … Continue reading Technologies for Cures
eHealth Law Blog 