America should be a global leader in healthcare. Instead, we rank last among our peers, and outmoded regulations are holding us back. 

The post How Regulatory Ambiguity is Impeding Healthcare Innovation appeared first on MedCity News.

Three upcoming Supreme Court decisions have the potential to radically change FDA regulation of medications.
The cases, which involve “Chevron deference” and the abortion pill mifepristone, were discussed on a panel during the BIO conference in San Diego.

The post Why a SCOTUS Ruling on Fishing Rules Could Change How FDA Regulates Drugs appeared first on MedCity News.

Where we’ve been, where we’re going, and how healthcare organizations can protect themselves from privacy risks caused by the Meta pixel and other third-party trackers

The post The Rising Stakes of Healthcare Data Privacy in 2024: The Need for Practical Guidance appeared first on MedCity News.

The life sciences industry is more quickly adapting to new methods, standards and requirements. The focus is now on how to drive greater data governance and quality through a unified framework.  The challenge comes in instituting a framework that will meet regulatory and labeling requirements.

The post The future of regulatory labeling compliance depends on technology adoption appeared first on MedCity News.

An action plan shared by the FDA earlier this year showed how the regulator is thinking about future regulations for AI and machine learning in healthcare. But the agency still has several big questions to address as it prepares to roll out new guidance.

The post FDA faces big questions as it takes a closer look at AI regulations appeared first on MedCity News.

In the final days of the Trump Administration, the Department of Health and Human Services sought to deregulate 83 different types of medical devices, citing a lack of reported adverse events. But the Food and Drug Administration put an end to the sudden reversal, saying the proposed exemptions were “flawed.” 

The post HHS reverses previous administration’s push to deregulate more than 80 medical devices appeared first on MedCity News.

The federal price transparency rule for hospitals went into effect Jan. 1, but a new analysis shows that a majority of providers studied were “unambiguously noncompliant.”

The post Analysis: Most hospitals not complying with price transparency rule   appeared first on MedCity News.

The agency published its first action plan last week for how it plans to regulate machine learning-based software as a medical device. To start, the FDA said it will issue guidance on how changes to algorithms should be regulated as they “learn.”

The post In the final days of Trump administration, agencies clashed over how to regulate medical AI appeared first on MedCity News.

AI tools increasingly occupy a regulatory gray area in healthcare. For clinicians to assess whether they are trustworthy, they need transparency on how they work, said panelists at CES.

The post At CES, experts say transparency key to ensuring AI tools work as intended appeared first on MedCity News.

The Center of Excellence is the FDA’s latest effort to take a closer look at digital health policies and its regulatory approach.

The post  FDA creates Digital Health Center of Excellence appeared first on MedCity News.

A final rule published by the Centers for Medicare and Medicaid Services on Friday would allows Medicare Advantage plans to cover more specialties through telehealth.

The post CMS expands telehealth options for Medicare Advantage plans appeared first on MedCity News.

There is a rumor out there that Amazon is about to launch a HIPAA-compliant Echo device, which is expected to drive greater adoption of voice in healthcare. But what does it mean for a smart speaker to become HIPAA compliant and what can voice do today?

The post Is Amazon going to announce a HIPAA-compliant Echo device soon? appeared first on MedCity News.

European Medicines Agency faces greater loss of staff than anticipated, forcing it to scale back or suspend some activities.

The post European drug regulator to cut activities ahead of move to Amsterdam appeared first on MedCity News.