Compliance & Legal

Abstract image of AI brain and technology
By Mike Miliard 11:19 am December 17, 2024
HHS' Office of the Assistant Secretary for Technology Policy, along with the Office of the Chief Artificial Intelligence Officer, has compiled a list of healthcare use cases as required by executive orders of both the Biden and Trump administrations.
Man in black tshirt codes on a laptop
By Andrea Fox 04:31 pm December 16, 2024
The EHR Association is urging the agency to address members' concerns and finalize additional decision support intervention measurements proposed in the draft rule, and clarify uncertainties that could compromise the quality of submissions.
Suspect in fatal shooting of UnitedHealthcare CEO Brian Thompson
By Susan Morse 11:21 am December 10, 2024
In manifesto, Mangione reportedly viewed killing as a "symbolic takedown" of healthcare industry.
UnitedHealthcare CEO Brian Thompson
By Susan Morse 02:30 pm December 04, 2024
The gunman reportedly targeted Thompson, waiting for him as he arrived at an investors' conference in Midtown Manhattan.
FDA signage
By Andrea Fox 11:30 am December 04, 2024
The agency said it will review developers' modified Predetermined Change Control Plans for artificial intelligence and machine learning submissions that have already been approved without triggering the need for new marketing submissions.
The U.S. Capitol, Washington, D.C.
By Mike Miliard 11:04 am November 27, 2024
The Health Care Cybersecurity and Resiliency Act of 2024 would provide grants to help healthcare organizations strengthen prevention and response - and push for better coordination between HHS and CISA.
HHS building
By Andrea Fox 10:46 am November 27, 2024
The Office of Civil Rights could have initiated follow-up after discovering security flaws, but "rarely initiated these reviews when it identified serious compliance issues," according to the HHS inspector general's audit program review.
A doctor with glasses sits at a desk and speaks during a telehealth visit.
By Andrea Fox 10:34 am November 18, 2024
The third extension of pandemic-era telehealth flexibilities through the end of next year will give the agencies time to promulgate final regulations and providers time to comply, the agencies said.
Sign outside FDA office
By Andrea Fox 10:20 am November 15, 2024
In a letter to the FDA, members of Congress cite confusion over providers' deployment of clinical decision support software that is exempt from medical device regulations and call for clarity from its Center for Devices and Radiological Health.
Former Georgia Rep. Doug Collins
By Mike Miliard 10:01 am November 15, 2024
The former GOP congressman from Georgia has served as a U.S. Navy chaplain and is a colonel in the Air Force Reserve. He would inherit a major EHR modernization initiative, currently paused but slated to restart in 2025, among other IT imperatives.