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.
Munck Wilson Mandala Partner Greg Howison shared his perspective on some of the legal ramifications around AI, IP, connected devices and the data they generate, in response to emailed questions.
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."
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.
At the Abarca Forward conference earlier this year, George Van Antwerp, managing director at Deloitte, discussed how social determinants of health and a personalized member experience can improve medication adherence and health outcomes.
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?
European Medicines Agency faces greater loss of staff than anticipated, forcing it to scale back or suspend some activities.
We will highlight Build My Health's revenue practice management tools, which could help physician practices add up to $250,000 to their practices.