The digital health gold rush is on. Teledoc’s $18.5 billion acquisition of Livongo reflects the valuation and consumer demand for virtual care. The capital, talent, utilization — and, let’s face it, speculation — driving the boom are creating a historic opportunity to reimagine how health care works and who it works for.
We may one day look back on this moment and say, “That’s when the digital health transformation became real.” Or maybe it went bust as investors and the public turned their backs on the hype and unfulfilled promises.
Digital health companies are making broad promises about immediacy, universal access, affordability, early detection and intervention, treating the untreated, overcoming the social determinants that have been barriers to good health. Making good on those promises, and completing a transformation into an industry that people not only trust but turn to, is serious business. Establishing industry-wide standards for research, clinical validation, and accessibility will be vital to guiding the mission.
Where to start? Not necessarily where you might think. We need to aim for a higher bar than the one traditional clinical medicine is meeting. As Atul Gawande wrote in The New Yorker, “Millions of people are receiving drugs that aren’t helping them, operations that aren’t going to make them better, and scans and tests that do nothing beneficial for them, and often cause harm.”
Evidence-based medicine aims to address the problems he raises by requiring a higher standard for clinical evaluation and outcomes than traditionally has been used in the medical field. For the digital health industry to fulfill its promise, it must meet the standards of evidence-based medicine or it will tilt toward the same problems of providing care that is ineffective or even harmful.
The digital health boom is racing ahead with only limited regulatory oversight as the FDA and others struggle to catch up to field whose innovations are outrunning the authorities. That’s to be expected. FDA regulation has historically been evolutionary, adapting to innovations and therapeutic advances rather than anticipating them. As the FDA increasingly adapts and extends its reach, it will establish a floor for the industry.
But regulatory authorities will never set the clinical and scientific standards needed to ensure a high quality of care. The onus is on the industry to do that — and then meet them. Even if it is possible to sidestep standards now, that won’t be the case as the industry matures, and health care providers and payers will be watching how it moves forward. I see three objectives as critical components for leading digital health forward with evidence-based standards.
Prioritize high-quality and transparent research. The standards of evidence-based medicine require not only a sufficient foundation of research backing any specific intervention, they also require a high level of quality as well as transparency, which is integral to assessing the quality of evidence. While there has been attention on the gaping lack of evidence in digital health, less discussed are the problems of evidence quality.
To elevate the industry to the standards of evidence-based medicine, digital health interventions must be evaluated in multiple randomized controlled trials that replicate clinically meaningful outcomes within appropriate populations. Standard measures to ensure scientific integrity and safeguard against bias must be followed, such as publishing trial protocols in advance of commencing a study and publishing the results in peer-reviewed journals — regardless of the outcome. Shielding research from scrutiny will undermine the credibility vital to the success of digital health. The methods and outcomes of research must be shown publicly as a matter of standard industry practice. Our reputations — and people’s health — depend on quality and transparency in our research.
Make research inclusive. Unlike doctors, researchers choose their patients. The potential for digital health to reach all populations can be realized only if research includes people whose profiles bring different challenges to outcomes — people over age 65, people of color, people with comorbidities. If the digital health industry is serious about using innovation to expand the impact of health care, that ambition must start in the development and testing stage — and be made public.
Meeting the standards of evidence-based medicine means measuring it against the most challenging real-world needs. This goes well beyond the conservative inclusion criteria that may be sufficient to gain regulatory clearance. It’s incumbent on the industry to recognize and meet a higher standard that is essential for patients, payers and providers.
Make access our mission. The concept of billions of people using mobile technology for virtual treatment — at their disposal 24 hours a day — is a game changer. But by focusing on the technology, we run the risk of being thought of as a “digital toy” industry, or — more defeating — as catering to privilege. Better, cheaper, faster is of no value unless it makes a difference in people’s lives. Staying true to a mission of putting patients at the center of what we do — our research, our design, our outreach — is key. As an industry, we must work to ensure that the populations who have been underserved by the current medical system have equal access to the digital health tools that can help.
The digital health industry has been given a gift: the resources to solve the problems of health care in a new way. It’s a huge opportunity and a huge responsibility. Now, in these early days, is the time to get it right. The risks — literally, life and death — are too high to accept what other technology categories have considered reasonable standards for backing product claims. Companies will surely be called out quickly if they rely on a lesser standard.
I call on the digital health community to seize this moment: Commit to rigor and transparency in your research. Commit to increasing equitable access to care. Commit to establishing evidence-based medicine as the foundation of digital health.
Not doing so will fail the people who have invested so much in the success of digital health and those the industry exists to serve. Patients shouldn’t stand for anything less, and neither should we.
Jenna Carl is the vice president of clinical development and medical affairs of Big Health, a digital therapeutics company focused on mental health.
