There are many “rules” that are being bent in this time of crisis. One of them not getting much attention is a recent announcement by the U.S. Food and Drug Administration (FDA) that it will temporarily approve a range of digital health devices intended to aid treatment for mental health disorders (see FDA Guidelines Temporarily Expand Access To Low-Risk mHealth & Telemental Health Devices).
The new rule waives the need for tech developers to submit a 510(k) premarket notification, corrections and removals requirements, registration requirements, and unique device identification requirements. The crisis waiver applies to two categories of digital devices during the duration of the crisis:
- Computerized behavioral therapy and other digital health therapeutic devices for psychiatric disorders
- Low-risk general wellness and digital health products for mental health or psychiatric conditions
According to the FDA, this would make digital therapeutic apps and “low-risk” telemedicine tools for mental health more available. But this does not apply to any technology that either replaces psychiatric care or treats urgent psychiatric conditions (see Enforcement Policy For Digital Health Devices For Treating Psychiatric Disorders During The Coronavirus Disease 2019 (COVID-19) Public Health Emergency: Guidance For Industry & FDA Staff).
In addition to technology focused on mental health, the FDA has also announced new policies that permit an expanded use of connected, non-invasive remote vital sign monitors (see Enforcement Policy For Non-Invasive Remote Monitoring Devices Used To Support Patient Monitoring During The Coronavirus Disease 2019 (COVID-19) Public Health Emergency), as well as expanded use of remote ophthalmic assessment and monitoring devices (see Enforcement Policy For Remote Ophthalmic Assessment And Monitoring Devices During The Coronavirus Disease 2019 (COVID-19) Public Health Emergency).
These types of digital technologies will change behavioral health service delivery in a way that telehealth will not. Telehealth involves the one-on-one interaction with a clinical professional using a tech platform. Many of the digital therapeutic devices that would be temporarily approved under this FDA crisis waiver actually are a substitute for some clinical professional time (even though the FDA and the technology developers would say not). Using branching decision support logic and artificial intelligence, they provide a “therapeutic interaction” that, for some consumers, will preempt the need for a one-on-one relationship with a clinical professional. And because the price point of the digital therapeutic technology is fixed regardless of the number of users, the effect will be to lower the average cost per consumer for behavioral health therapy.
So, the big question for strategy in specialty provider organizations is whether these waivers—and these technologies—will become “permanent.” Seema Verma was quoted as saying that the “genie is out of the bottle” on telehealth (see ‘The Genie’s Out Of The Bottle On This One’: Seema Verma Hints At The Future Of Telehealth For CMS Beneficiaries) and likely to stay. I would say that the same is likely true for these new apps and treatment technologies. The smart technology developers will be using this time to complete a demonstration project that proves their technology’s real-world, at scale efficacy—which will be both speed adoption and FDA approval.
The questions for strategy are, first, how can specialty provider organizations take advantage of these newly-approved technologies during the crisis and afterward? And second, assuming these new technologies are widely adopted and get post-crisis approval, how will this affect strategy? OPEN MINDS Senior Associate Sharon Hicks noted that approval and widespread use of these devices will affect the market in ways that we can’t yet understand, even though we have seen consumers accept these as an alternative for outpatient therapy. She cautioned however, noting:
“Of greater uncertainty is how the distribution and use of these types of devices is going to affect the traditional behavioral health provider market. It may parallel the type of change that was seen around primary care practices when the urgent care centers became commonplace. Prior to that new competition, it was acceptable that people had to wait weeks to see their doctors, that offices were not available on weekends or in the evening, and that waiting times in the offices could be extensive. Now, because people voted with their wallets that paying for urgent care was worth avoiding the hassles of the doctor’s offices, many practice groups have dramatically improved the service-related components of their operations.”
OPEN MINDS Senior Associate Paul Duck noted that the strategic impact of this move may be fairly straightforward, explaining: “Those organizations that are innovating in times of crisis are positioning for a whole new era of health care. While many of these advancements were taking place methodically, the COVID-19 pandemic has accelerated the need and acceptance, and forced regulatory hurdles previously in place. This is a time for organizations to innovate and partner like never before.”
Mr. Duck had one other comment that I think serves as a great guidepost for executives: “The legacy mindset about what works and does not work, based on old understanding with no room for understanding how technology supports therapy—or could support therapy—won’t work. Those organizational leaders and managers are likely to find themselves lost and wondering why ‘all the hype.’”
My take is that the widespread availability of digital behavioral health therapies will “remove” a whole group of consumers who have mild behavioral health conditions that can be resolved with “packaging” the essence of evidence-based practices. And the innovative leaders of behavioral health organizations will embrace them as a competitive edge in a market increasingly focused on value. For more on adopting tech, check out these resources from The OPEN MINDS Industry Library:
- Going From Tech Tolerant To Tech Savvy: How Managerial Staff Can Directly Impact The Adoption Of Technology
- 4 Tech Competencies For Sustaining Financial Success
- Tech Step #4: Engaging Consumers Using Technology
- Health Tech That Will Change Our Lives
- Building Your Own Tech-Enabled Consumer Base
- We Don’t Have An EHR & We Won’t Do Email
- In All That Tech Spending, Don’t Forget The ROI
- For Telehealth, The ROI Is Where You Plan For It
- The Future Of Treatment Tech Is Blended
- The Health & Human Service Executive’s Blueprint For Tech Strategy Development
For more on balancing the need to innovate with the need for revenue, register for our upcoming web briefings in our Executive Blueprint For Crisis Management series:
- July 2: Executive Portfolio Management In Time Of A Market Shift – What Programs To Keep & Which To Close?
- August 6: Getting Paid – More – For What You Do – Tactical Approaches Of Increasing Fees & Rates From Payers & Moving To New Reimbursement Models With Payers
- August 13: Planning For Revenue Expansion By Expanding Your Service Area – From Market Analysis To Launch
If you have questions about your organization’s OPEN MINDS Circle membership/subscription level and whether you can participate in these sessions at no cost, just call our toll-free number 855-559-6827 or email us at email@example.com.