The Food and Drug Administration has recently announced a program that actively encourages the development of medical digital technology, including wireless wearables and applications that can monitor blood pressure and heart rate, track intake of calories, and measure physical activity.
The program is designed to give pre-clearance to developers working on digital health products, as the approval process for apps sometimes includes burdensome regulations, which can increase costs and limit innovation: the FDA hopes to reduce development costs and give entrepreneurs increased opportunities to develop products.
Research experts suggest that increases in medical technology could not only increase access to care in rural, underserved communities, but also significantly drive down costs.
The pilot program includes pieces of legislation sponsored by Tennessee Congresswoman Marsha Blackburn. “Think about the home health visits for our Medicare enrollees, the home health nurse that checks in on them periodically can now do that by Skype,” said Blackburn. “It is a huge win in getting to a more efficient, more cost effective delivery of healthcare services.”
A recent FDA blog post outlines several efforts underway in order to foster medical innovation, stating that the FDA is currently undertaking a broad initiative “to advance policies that promote the development of safe and effective medical technologies that can help consumers improve their health.”