Regulation

Michael Needham, principal at Efficio, says the Trump administration's tariffs create uncertainty and indecision for business.  

Independent accreditation is essential to ensure that health technology and health organizations are compliant with HIPAA, NIST and other standards, says Kathryn Ayers Wickenhauser, DirectTrust's chief strategy officer.

Also, fellow Korean medical AI companies have obtained regulatory approvals across global markets. 

While the change of administration means federal regulations and funding remain in flux, PointClickCare's Brian Drozdowicz believes healthcare vendors and organizations are making strides in improving interoperability.

Jonathan French, HIMSS' senior director of public policy, lays out the key points of HIMSS' response to the White House's request for information from the public on developing an AI action plan.

Michael Ramey, managing principal of Strategic & Transaction Solutions at PYA says due to changes in the FTC's new premerger notification rules, he's advising clients to be prepared to disclose more information and undergo greater scrutiny.

If some cuts to NIH and other research programs extend deeply and are rolled out in a disorganized way, they have the potential to compromise biomedical innovation in the United States, says Vik Bajaj, cofounder and CEO of Foresite Labs.

Two new memos update federal AI policy, which the White House says will accelerate innovation, strengthen public trust and prioritize U.S.-developed AI tools.

Ben Wolf, partner in Alston & Bird's Health Care Group, told MobiHealthNews how FDA staffing cuts could slow device approvals and what companies can do to stay ahead.

The judge ruled that the FDA overstepped its authority by regulating LDTs as medical devices, overturning the rule and remanding it to the HHS Secretary for review.