A bipartisan group of representatives has introduced a new bill, Sensible Oversight for Technology which Advances Regulatory Efficiency (SOFTWARE) Act to provide regulatory clarity regarding mobile medical applications, clinical decision support, electronic health records, and other health care related software.
According to the announcement,by building on the guidance recently released by the FDA and codifying their risk based regulatory approach this important legislation provides the regulatory certainty that technology companies need in order to continue to drive innovation and ensure patient safety.
With the consumer consumption of medical apps expected to grow to 500 million by 2015, the FDA lacks the infrastructure to oversee these apps without stifling innovation. Currently, the FDA could use its definition of a medical device to emphasize broad regulatory authority over a wide range of software. The SOFTWARE Act tailors their authority to the realities of the 21st century by focusing their authority onto the products that pose a potential risk to human health.
The Sensible Oversight for Technology which Advances Regulatory Efficiency (SOFTWARE) Act seeks to amend Section 201 of the Federal Food, Drug, and Cosmetic Act to regulate medical software and to provide guidance to the FDA about mobile medical app regulations.
According to Rep. Diana DeGette: “As technological advances change the face of medicine in the 21st century, the FDA is hamstrung with outdated tools that limit oversight and could ultimately stifle innovation. This bill will help create a regulatory framework that ensures emerging technologies are effective and secure, while protecting patient safety. The SOFTWARE Act is also a great example of bipartisan cooperation paving the way for a stronger, healthier future for our country.”
For more information:
Read the full text of SOFTWARE ACT (PDF)
