In a major announcement this week, the FDA has said it will lower some of the regulatory hurdles that big technology companies such as Apple, Samsung and Alphabet will face developing software tailored towards medical use. This step signals optimism for the 9 firms which have been chosen to fast track their pilot software through the usually cumbersome process.
Big and massive technology companies such as Apple, Samsung moving into the healthcare space
The 9 firms which have been chosen are:
- Johnson & Johnson
- Pear Therapeutics
- Verily (owned by Alphabet)
This program which the 9 companies are on is known as the “Precertification Pilot“. What this means for the chosen companies is that these companies can be precertified if they meet certain quality standards. This will be decided after FDA reviews factors such as their software designs, validation and maintenance. Through this program, the FDA hopes to decide on some of the key performance indicators for precertification such that precertified firms can submit less information before being able to market a new health tool which might fall under part of a formal program. Something in consideration would also include a product has to be submitted for review in some cases.
My interpretation for the program and just making things really simple
Given that there is a lot of information, I believe the act is attempting to simplify the process which medical software can be distributed in the free market through working with some of the leading pharmaceutical and technological companies in the world. Apparently, over 100 applications from various companies were received and this notion is part of FDA’s Digital Health Innovation Action Plan, launching the pre-cert pilot program on 27 of July.
What this means for the community?
There are many responsibilities for the companies involved in the program, including access to tools and data which might potentially be shared, and compliance with site visits by FDA staff. Yet, this could potentially increase the rate of healthcare innovation as the industry has traditionally been heavily regulated.
FDA is aiming to drive potential software which can benefit health in the long run and we see this as an encouraging sign. Just wondering if the data received from the program will be shared so consumers and patients will know the outcomes from the program. Another point of consideration is what will these software do to benefit health and which specific diseases will be under scrutiny?
We are looking forward to more updates and will cover them accordingly. What are your thoughts?