software as a medical device

Top 5 regulatory trends impacting Software as a Medical Device (SaMD)

As the biopharma space gets more competitive and the days of blockbuster drugs seem further in the rearview, biopharma companies are investing in digital to find new and innovative ways to differentiate themselves. These next-generation tools create more personalized experiences for patients, more information to guide clinical decision making and plenty of data for biopharma companies to use to continually improve therapies and to make a case for reimbursement.

By Mark Tarby

Clinical decision support guidance tops FDA’s agenda for 2022

The FDA plans to publish a final guidance around clinical-decision support tools in the next year. It would be a much-anticipated update, after the FDA shared a draft guidance around the issue in 2019.

By Elise Reuter

With the Rise of AI, What IP Disputes in Healthcare Are Likely to Emerge?

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.

Artificial Intelligence, Legal

MedCity Pivot Podcast: The stakes are high for getting AI right in healthcare, says Duke Forge director

It's important for clinicians to consider AI recommendations with a critical eye, the same as they would for any other test, said Dr. Erich Huang, Director of Duke Forge. In our latest podcast episode, he spells out the stakes for implementing algorithms in healthcare, which can potentially affect thousands of patients.

By Elise Reuter

MedCity Influencers, Policy

The road ahead for FDA’s Pre-Cert program

FDA has taken important steps to develop the Pre-Cert program collaboratively with the software industry through a pilot but it has revealed areas where the program needs refinement.

By Aaron Josephson

Artificial Intelligence, Startups

What’s needed to effectively bring AI to healthcare?

A new report from the Duke University Margolis Center for Health seeks to shed light on the current state of AI technology in healthcare and how to effectively drive adoption of AI-based clinical support tools.

By Kevin Truong

Events, Artificial Intelligence

Challenges and opportunities in FDA’s new digital health regulations

A range of companies at the Digital Health showcase in San Francisco discussed how they view the changing regulatory environment within the category of software as a medical device.

By Kevin Truong

Policy

Amidst plans to expand FDA digital health pre-certification pilot program, concerns about its future

Bakul Patel — digital health director at CDRH — acknowledged that the group is still figuring out how the pre-certification program should look.

By Stephanie Baum