The Digital Healthcare Revolution Has Begun
Recent changes made by the FDA have made it easier for digital health products to be cleared and approved
Before COVID-19 hit, digital therapeutics (DTx) companies have always faced huge regulatory barriers and long approval times. Even leading pharmaceutical and insurance companies were slow to adopt them. But in recent months, these obstacles have begun to diminish.
Korea’s Seagene and Kogene Biotech test kits, which would’ve taken 2–3 years to approve, were approved by the FDA in under 3 weeks. Livongo received approval after a week, allowing its at-home glucose monitors to be used in hospitals. FDA also recently loosened regulations for the use of software tools for mental health, allowing Pear Therapeutics to release Pear-004 without approval, a DTx for schizophrenia.
Digital healthcare startups have taken on the important roles of caring for patients impacted by the virus and maintaining a functioning healthcare system as it shifts towards remote care. The rise of DTx, a subcategory of digital health, is primed to accelerate as they replace or augment treatments that traditionally have been provided in-person.
Millions of people are beginning to take their healthcare online. SolvHealth has seen a 3,400% increase in video consultations and a 2,575% increase in telemedicine doctors. Capsule has seen a 500% increase in new remote patients. TwentyEight Health, which delivers prescription by mail, also seen a bump.
A New Regulatory Landscape
Last year, the FDA made four main regulatory changes that could accelerate and provide a streamlined path to approval for digital health products: The Digital Health Software Precertification (Pre-Cert) Program, Multiple Function Device Products, Prescription Drug Companion Apps, and OTC Drug Digital Labeling.
In the case for PiCO GO, we want to draw the attention to the pre-cert program. This will “pre-certify” eligible companies (e.g. us) who satisfy certain FDA excellence criteria and then have their products reviewed in a streamlined way, paired with real-world health analytics, product performance analytics, and user experience components. Companies can then market their devices without additional FDA review. In addition to reducing the time and cost of market entry, this model could eventually become how many digital health products come to market.
The companion app will allow digital tools, which supplement prescription drugs (e.g. asthma medication), to be regulated as labelling instead of going through a separate process. Finally, OTC will allow drugs to be approved based on evidence that patients can use digital labelling to select a drug for treatment (allowing PiCO GO to be sponsored for patients who use certain asthma medication — all done digitally).
On a wider note, US Vice President Mike Pence recently announced that healthcare providers will be allowed to practice across state lines, unlocking a greater supply of providers for digital health companies. The changes, combined with higher reimbursement rates for telemedicine set by Centers for Medicare & Medicaid (CMS), could help solve the problem of insufficient clinical professionals on these platforms, further boosting the digital healthcare industry. Lastly, the Drug Enforcement Agency recently provided new guidelines on the Ryan Haight Act, permitting providers to prescribe controlled substances remotely without a prior in-person exam.
In addition to these 4 regulatory changes and recent announcements by other federal agencies, FDA also has long had emergency authorizations to fast track products that fill urgent needs in the health market, e.g. Fast Track, Accelerated Approval, and Priority Review.
Why This Matters?
The Digital Health Innovation Plan outlines the FDA’s seriousness and efforts to modernize their policies and approach to ensuring all Americans have timely access to high-quality, safe, and effective digital health products. They have even increased the number of digital health staff, recognizing that many stakeholders are involved in it, including patients, health care practitioners, researchers, traditional medical device firms, and firms new to the digital healthcare landscape.
The principal beneficiary of this revolution will be the patients that use digital therapeutics. Although it has taken a tragedy like COVID-19 to spur these changes, the effects of COVID-19 will last forever. After the pandemic subsides, it will lead to more options, lower prices, and greater access to innovative treatments.
Soon, your doctor may prescribe you an app instead of a pill.
To inquire more about Brilliant & Company, please do not hesitate to drop us a line:
- CEO / Ryan Yun / ryan.yun@brilcom.com
- Global Marketing Manager / Steve Tan / steve.tan@brilcom.com
