What the 21st Century Cures Act means for digital health & innovation
After three years in the making, President Obama signed the 21st Century Cures Act into law in mid-December.
The pharmaceutical industry and some patient advocacy groups herald the legislation for reducing the layers of bureaucracy through which drugs must pass in order to be approved. It enables drugs to get to market faster.
The legislation also provides billions of dollars to the National Institutes of Health (NIH) to conduct research, and to state governments to combat the opioid epidemic.
It’s quite obvious what this means for big pharma. But what does the 21st Century Cures Act mean for digital health?
Millions in new business for healthcare IT
While drug companies are often considered to be the big winners in the new legislation, healthcare IT will also come out on top. New incentives (and penalties for failing to comply with new standards) mean millions in new investments to improve data interoperability and research. This includes both implementations of new IT systems and upgrades to existing ones.
A flood of digital health apps
The 21st Century Cures Act provides $1 billion to help end America’s opioid dependency and substance abuse epidemic. Most substance-abuse treatments start inside a medical facility and continue into the real world as patients progress through the recovery process. This makes digital recovery support apps not only ideal but also highly effective. The new attention and funding in this space will provide a much-needed bolt of innovation to the entire substance abuse and mental health ecosystem with a focus on digital.
Precision medicine is here to stay
Precision medicine is the approach of taking genetics, behavior and environment into consideration when choosing disease prevention and treatment options. With thousands of behavior change support apps and a handful of consumer genetic testing services, which are now becoming mainstream, digital health has led the healthcare sector in precision medicine. This legislation ensures that large research efforts and nascent pilot implementation programs will continue.
Increased efficacy research studies
Despite billions in venture capital, digital health has yet to prove its efficacy, leading the American Medical Association’s vice president, James L. Madara, to label the sector as “digital snake oil.” With increased and sustained NIH funding approved under the 21st Century Cures Act academics and researchers will likely take note of the broad interest and propose studies that include digital health components, helping to close the evidence gap.
FDA can consider real world evidence
One of the key provisions in the legislation allows the FDA to consider real-world evidence when approving treatments, drugs and medical devices — effectively bypassing Phase III trials. This is essential when a randomized controlled trial (RCT) is logistically, ethically and operationally impossible, like in an Ebola infection outbreak, or with rare and orphan diseases.
But the key word here is “consider.” Each FDA office will continue to review applications on a case-by-case basis. The medical community considers the RCT the gold standard. Unless there are ethical or operational issues that make an RCT impossible, it’s still the research technique that FDA regulators, physicians and payers view as the most credible.
The digital health industry started 2016 on unsteady footing, with negative press coming out of the JPMorgan Chase Health Conference, FTC fines against Luminosity, and the Theranos scandal. The 21st Century Cures Act ensures that 2017 and beyond will be much more promising for digital health. More funding, more rewards for innovation, less regulation and attention to real health needs will continue to make digital health the must-invest space.
Originally published at www.bizjournals.com.
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