After more than three years, President Barack Obama finally signed the 21st Century Cures Act into law earlier this month. What does the 21st Century Cures Act mean for digital health? It means better health data interoperability for those who support it and penalties for those who block it.
While drug companies have been credited as the big winners in the new legislation, in reality it might be healthcare IT. New incentives and penalties mean millions in new business for enhancements and new systems to improve data interoperability and implement new systems that improve research.
The 21st Century Cures Act provides $1 billion to help end America’s opioid dependency epidemic. Substance abuse treatment has a strong behavioral and maintenance component that happens outside a medical facility. These are treatment components that digital health is particularly suited to. It’s likely that the attention on opioid addiction will lead to digital health solutions spilling over into other areas of substance use such as alcoholism.
Precision medicine is here to stay and digital health will continue to lead.
Precision medicine is the approach of taking genetics, behavior, and environment into consideration when choosing disease prevention and treatment options. Digital health has lead the healthcare world in this area with thousands of behavior change support apps and a handful of consumer genetic testing services. This legislation ensures that large research efforts and nascent pilot implementation programs will continue.
Increased funding to medical schools and academic institutions will increase efficacy research on digital health solutions.
Despite billions in venture capital, digital health has yet to prove its efficacy, leading American Medical Association CEO Dr. James Madara to label ineffective electronic health records, direct-to-consumer digital health products, and many apps “digital snake oil.” With increased and sustained NIH funding approved under the the 21st Century Cures Act, academics and researchers will likely take note of the broad interest, and propose studies that include digital health components to help close the evidence gap.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
The FDA can now consider real world evidence for regulated digital health solutions. But they still will likely require a randomized control trial, or RCT.
One of the key provisions in the legislation allows the FDA to consider real world evidence when approving drugs and medical devices, effectively bypassing Phase III trials. This is essential when an RCT is logistical, ethically and operationally impossible, such as in the case of an Ebola Virus outbreak, or with rare and orphan diseases.
But, relatively few digital health solutions require FDA clearance; the few that do probably are not used in the extreme circumstances where the FDA will consider real world evidence as the only suitable data collection opportunity. The broader medical community still considers the RCT the gold standard, and will likely continue to require it.
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