This week at HLTH, FDA Commissioner Robert Califf discussed the current state of healthcare AI. He talked about some of the qualms he has, such as his worry that AI is worsening health inequities and his concern that providers aren’t capable of validating AI tools’ effectiveness.
Many great ideas fail because of a fundamental misunderstanding or underestimation of the unique barriers entrenched within healthcare. Here are some key considerations that innovators from non-healthcare backgrounds need to be prepared for.
The progress in artificial intelligence (AI) is reshaping patient care, across various dimensions, from facilitating faster discharge to curating treatment plans and suggesting lifestyle changes.
In healthcare, a faulty algorithm can be a matter of life and death.
America should be a global leader in healthcare. Instead, we rank last among our peers, and outmoded regulations are holding us back.
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.
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 future looks bright for the integrated specialty pharmacy model – for health systems, providers, and most importantly, for patients.
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.
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.
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 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."
Hear executives from Quantum Health, Surescripts, EY, Clinical Architecture and Personify Health share their views on digital transformation in healthcare.
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.”
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 Center of Excellence is the FDA's latest effort to take a closer look at digital health policies and its regulatory approach.
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.
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?