The U.S. Food and Drug Administration has started the process of extending its oversight over digital health products and services as part of its statutory authority regulating medical devices.
As a result, the likely outcome is that those who manufacture or sell products deemed to be medical devices according to the FDA definition will be required to demonstrate their safety and efficacy, like medical devices now. What's more, some are predicting that EMRs and other digital data products will fall under the FDA's purview. The impact on digital health, telemedicine, analytics and other tools could be substantial and will require a digital health clinical trial ecosystem to execute trials.
The barriers to constructing such CRADLEs -- Collaborative Research and Development Learning Ecosystems -- are substantial. They include:
- Building collaborative organizations and policies to conduct the trials involving industry, academia and community health care delivery systems.
- Removing the firewalls and barriers around access to patient data.
- Developing a mechanism to fund the trials.
- Developing a digital health CRO infrastructure around the world, similar to what exists for drugs and devices today.
- Minimizing FDA regulations that would stifle innovation, yet, at the same time, protect the public health, the core mission of the FDA.
- Create a mechanism for publishing both the positive and negative results of the trials, possibly on a site like clinicaltrials.gov.
- Creating a trained workforce to conduct the trials.
International CRADLEs would provide a collaborative environment to conduct digital health clinical trials as a step toward getting FDA clearance and informing the public about the safety and efficacy of digital health products and services. Now is the time for stakeholders to convene to create the future of digital health and how they will be regulated, manufactured and sold.