regulation

A provider conducts a telemedicine visit through a laptop
By Dave Muoio 03:14 pm October 28, 2020
This month saw the annual release of Epstein Becker Green's Telemental Health Laws Survey, a state-by-state review of behavioral telehealth legislation, regulation and policies. Available in full as a free Android and iOS app, this year's breakdown includes regulation information for Puerto Rico, alongside the 50 states and Washington, D.C. WHY IT MATTERS Outside of compiling state-specific...
By Dave Muoio 03:09 pm October 12, 2020
As healthcare becomes more digitized and clinical treatments shift away from one-size-fits-all therapies, the industry will need to become more critical about how it's employing and curating health data. For vendors and providers, it's about understanding what tools are at their disposal and how they can be implemented to maintain and improve the standard of care. But for regulators like the FDA...
By MobiHealthNews 11:42 am October 9, 2020
With its recent launch of the Digital Health Center for Excellence, the FDA has shown a new spotlight on its ongoing work of changing how the regulation of digital health and digital therapeutics works, to better match the realities of modern technology. But is the organization taking the right steps for the right reasons? Or is it heading into dangerous territory for developers and their end...
By Dave Muoio 02:38 pm April 16, 2020
The FDA released new guidance on digital health devices for treating psychiatric disorders that waives several regulatory requirements – such as need to submit a 510(k) premarket notification – for the duration of the COVID-19 emergency. "Device availability may increase patient access to digital therapeutics while individuals are following 'stay at home' orders or practicing social distancing,...
By Dave Muoio 01:55 pm March 27, 2020
Yesterday, Pear Therapeutics announced the regulatory clearance of Somryst, its prescription digital therapeutic for chronic insomnia. And while the product is noteworthy for these patients and Pear's broader business, it also stands as a major milestone for the digital health industry – the first product to be evaluated throught the FDA's Digital Health Software Precertification Program. Now...
By Dave Muoio 04:32 pm March 23, 2020
Last week saw a number of diagnostic testing startups, telehealth providers and others announce new services that would deliver at-home COVID-19 testing-kits to consumers. But the majority of these of offerings have since been rescinded or hang in doubt thanks to new warnings and regulatory clarifications issued this weekend by the FDA. On Friday evening, the agency released an alert to consumers...
By Naomi Fried 01:47 pm January 28, 2020
Update: HIMSS20 has been canceled due to the coronavirus. Read more here. About the author: Naomi Fried, PhD, is the CEO of Health Innovation Strategies, which provides digital health strategy and innovation-program design and optimization consulting to healthcare stakeholders including pharma, payers and providers. Her previous positions include the first chief innovation officer at Boston...
By Laura Lovett 10:37 am December 4, 2019
Setting its sights on the European market, yesterday California startup VivaLNK announced that it landed a Class IIa medical device CE Mark for its multi-vital medical wearable sensor and software development kit.  Researchers and clinicians can use the technology to continuously stream a patient’s ECG rhythm, respiratory rate, heart rate, RR interval and three axis acceleration.  The product...
By Dave Muoio 04:07 pm November 19, 2019
Device regulation is a hurdle for any medical tech company, but doubly so for startups hoping to strike it big with their very first digital health product. With limited resources and experience, pushing a device through the FDA’s door and onto the market is a multi-year gauntlet of validation, documentation and, unfortunately, frustration. To help young companies take a bit of the guesswork out...
By Dave Muoio 02:50 pm September 26, 2019
This morning the FDA released two guidance documents relating to the regulation of various digital health software devices. The first is a draft guidance outlining categories of clinical decision support (CDS) products that would or would not require direct regulatory oversight from the agency. This is an update to a CDS draft guidance released in 2017, with the noteworthy addition of a risk-...