How will new legislation affect digital health products?

 In Medical Product Design

Indications suggest digital health technology has an important part to play in the future of healthcare. A recent study from business consultants Frost & Sullivan predicted that revenues from mobile health products would grow from $5.1 billion in 2015 to $18.9 billion in 2020. Two pieces of legislation that recently passed through the U.S. Congress could have significant implications for that future development.

"These laws represent shifts for how medicine is researched and practiced."

One of those laws is the Expanding Capacity for Health Outcomes Act, approved by the House of Representatives on Tuesday, December 6. The other is the 21st Century Cures Act, which passed the Senate the following day after years of complex negotiations, and addresses funding and regulation related to a wide variety of healthcare issues. These initiatives represent multiple shifts in the way medicine is researched and practiced in the U.S. and, in turn, those changes could make a major difference for the use of innovative medical products.

Bridging gaps for healthcare information

ECHO is meant to expand access to high-quality healthcare services for underserved populations through technology and programming. The law is based on the model of a "hub and spoke" telehealth program from the University of New Mexico Health Sciences Center, which was originally created to manage cases of Hepatitis C. The National Law Review explained the act calls for exploring the possibilities of using distance education and collaborative learning methods to connect specialists with doctors in rural or otherwise underserved areas.

Under the law, the Secretary of the Department of Health and Human Services will be tasked with investigating how this technology can address issues such as shortages in specialty care and improving public health programs. The HHS will also consider the possible uses for handling concerns like mental health, substance abuse, chronic disease or pain, prenatal health, pediatric care and palliative care. The resulting report will lay out best practices for using technology to offer better care to more people, and overcome any barriers to adoption.

Since ECHO only prioritizes further research within the next two years, the act does not immediately make any changes in how technology is utilized for healthcare. However, the passage suggests that digital health products will increasingly be a part of making treatment widely accessible.

Paving the way for new developments
The Cures act has wide-ranging implications for healthcare in the U.S., laying out new standards for the federal approval of both drugs and devices. The New York Times reported that the law will speed up how quickly new treatments and equipment for debilitating or life-threatening diseases or conditions get through the testing process and out to patients. In addition, the bill includes an allocation of $4.8 billion for the National Institutes of Health over a 10-year period to fund a variety of research.

According to MobiHealthNews, some of that funding could directly benefit the development and application of digital technology to treat those health issues. Among the projects is the Precision Medicine Initiative, which sets out to improve healthcare for individuals by addressing variables like their environment, lifestyle and genetics. The BRAIN Initiative is intended to speed up research into neurological function and disorders by accelerating technological innovations. Another initiative to benefit from the bill is the Cancer Moonshot, which is primed to make more effective new therapies available to patients on an accelerated timetable.

It remains to be seen just how the changes in U.S. law will impact medical device development and the clinical use of these digital health products. Nonetheless, the potential for these devices to be used in a wide range of applications is continuing to expand. The alterations in policy look poised to encourage a greater supply of devices on the market being used in more healthcare situations.


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