By HealthXL Team
In our Friday newsletter we recap the biggest news story of the week to make sure you don’t miss out on the latest trends, developments, and acquisitions in digital health. In case you missed it (ICYMI), this round-up will catch you up on the top stories from the past month.
To get the latest news in your inbox each week, sign up here to become a HealthXL Community member.
#1 Story: FDA Releases Final Results of its Digital Health Software Pilot.
The story: The FDA’s Centre for Devices and Radiological Health issued the final results of its Software Precertification Pilot Program, launched in 2017. The pilot program explored a new approach to regulating digital health software technologies based on regulating companies’ internal processes, cultural and organizational standards, instead of the individual apps or devices.
What you need to know:
Findings from the pilot, which were considered positive, demonstrate the potential for the FDA’s framework to address the challenges around regulating rapidly evolving software technologies in the modern medical device landscape, such as clinical decision support software (CDSS) and Software as a Medical Device (SaMD).
However, the report also highlighted the requirement for legislative change, as it is unfeasible to implement the FDA’s proposed software precertification program under the current statutory and regulatory legislation.
Industry implications:
The new guidance provides clarity on the FDA’s use of enforcement discretion for Software as a Medical Device (SaMD), mobile medical apps and categories of clinical decision support software. These regulatory support tools provide developers of these software with a framework for assessing whether or not their technology is subject to FDA regulation as a medical device.
The Digital Health Policy Navigator, launched to assist the companies in understanding these guidelines is a welcome addition. However, the FDA acknowledged that a statutory authority would be required in order to progress regulatory oversight beyond the pilot.
In other news...
#2 Story Snapshot: Sharp Decline in Q3 Digital Health Funding
The story: Q3 2022 digital health funding in the U.S. fell to the lowest level for 11 quarters. Funding dropped to just under half (48%) of funds allocated in Q2 of this year. Compared to the huge backing we saw last year, 2022 is lagging severely behind with only $12.6B raised so far compared to $21.3B this time last year.
Get the full story here.
#3 Story Snapshot: Walmart Aiming to Tackle Health Equity in Clinical Research
The story: Walmart announced the launch of the Walmart Healthcare Research Institute to address clinical trial diversity, aiming to improve community access to trials for traditionally underrepresented populations. The initiative will initially focus on recruiting older adults, rural residents, women, and minorities for studies on treatments for chronic conditions and other illnesses, which may lead to safer, more equitable healthcare.
Get the full story here.