February 25, 2021
The digital health ecosystem has swelled to encompass a broad range of products over the years.
On one end of the spectrum is software-as-medical-devices (SaMD) and prescription digital therapeutics, product categories for which a comprehensive regulatory strategy and engagement with the FDA are mandatory. On the other are wellness apps and other low-risk digital tools that likely spend more time...
December 17, 2020
Following months of regulatory investigation, the European Commission has officially signed off on Google's $2.1 billion purchase of health-wearable-maker Fitbit. Still, the go-ahead is contingent on a handful of commitments from the tech company that focus on its competitive practices across advertising, digital health APIs and smart device interoperability.
"We can approve the proposed...
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...
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...
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...
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,...
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.
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...
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...
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.