Policy & Regulations

This channel includes news coverage of healthcare policy and regulations set by Congress, the states, Centers for Disease Control and Prevention (CDC), the Department of Health and Human Services (HHS), U.S. Food and Drug Administration (FDA), and medical associations and societies. 

Brit study: Money-motivated parties weighed in heavily on FDA’s medical AI regulation

Of 125 public comments submitted to the FDA on how best to regulate AI software as a medical device, nearly two-thirds came from parties with financial ties to industry, according to a study running in BMJ Open.

Professional associations encircle CMS over 2021 Medicare fee schedule

Close to 50 medical organizations representing 1.4 million physicians and other clinicians are pressing CMS to amend the physician fee schedule (PFS) the agency has proposed for Medicare in 2021.

Playing the percentages on face masks: 5 points to ponder

Around the world during the COVID-19 pandemic, words have occasionally led to blows over people in public not wearing face masks. Then too, fisticuffs have erupted over people in public wearing face masks.

Initiative aims to leverage technology in mitigating healthcare disparities

AI is a key part of the plan as two groups with little in common come together over health disparities that have only been worsened by the COVID-19 pandemic.

New international coalition pushes patient advocacy agenda

More than 100 patient groups across 38 countries have banded together to form an international patient advocacy coalition to be known as the World Patients Alliance.

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Liability for following AI treatment recommendations not so clear-cut, but emerging patterns suggest safe pathways

‘We find that two factors reduce lay judgment of liability: following standard care and following the recommendation of AI tools.’

Primera Blue Cross hit with $6.85M penalty, corrective action plan for HIPAA violations

The resolution represents the second largest payment to resolve a HIPAA investigation in OCR history. It also includes a robust corrective action plan that calls for, among other things, two years of monitoring.

US residents may soon be buying drugs from Canada—legally

The Trump Administration’s main aim is widening consumer access to lower prices.

Around the web

Compensation for heart specialists continues to climb. What does this say about cardiology as a whole? Could private equity's rising influence bring about change? We spoke to MedAxiom CEO Jerry Blackwell, MD, MBA, a veteran cardiologist himself, to learn more.

The American College of Cardiology has shared its perspective on new CMS payment policies, highlighting revenue concerns while providing key details for cardiologists and other cardiology professionals. 

As debate simmers over how best to regulate AI, experts continue to offer guidance on where to start, how to proceed and what to emphasize. A new resource models its recommendations on what its authors call the “SETO Loop.”