Today, the Federal Trade Commission (FTC) released a tool for health app makers in coordination with Department of Health and Human Services’ Office of National Coordinator for Health Information Technology (ONC), Office for Civil Rights (OCR), and the Food and Drug Administration (FDA). In response, Morgan Reed, executive director of ACT | The App Association, released the following statement:
ACT | The App Association’s Connected Health Initiative has been pushing for better regulatory guidance for connected health companies for some time. This effort is a good first step, and we applaud efforts to move interface design into a more recent decade.
But, the tool doesn’t address many of the key questions that companies are asking. While companies need to know where they fit in the regulatory ecosystem, the most pressing issue is understanding how to meet those requirements.
There is still work to be done around defining how to provide cloud storage, how to determine what “on behalf of” means, and how to craft a Business Associate Agreement for third party data usage. Overall, questions remain around many elements of HIPAA, but we take a “glass half full” perspective on today’s announcement.