When Google in November 2018 hired David Feinberg to head up its healthcare efforts, it was just the latest sign of the tech giant’s ambitions in the sector. Feinberg was previously president and CEO of Geisinger, among the US’ largest and most forward-looking health service providers. Feinberg was already talking about using technology to transform healthcare delivery and costs before he left Geisinger. At Google, he’ll be well-placed to accelerate some of those ideas into reality.
Pharma has been slow to recognise the tech-threat. Some executives felt that the highly-regulated nature of the pharma industry would mean most technology firms would play outside the fence, sticking with fitness apps, wrist-worn heart rate monitors and online appointment-booking. Tech firms might make healthcare more convenient for consumers to access, the thinking went, but they wouldn’t fundamentally change its nature.
That thinking was off. Technology giants including Google, Apple and Amazon are not just hiring top-end healthcare innovators and regulatory experts (Amazon’s new hires include surgeon, author, and healthcare innovator Atul Gawande, who will lead the company’s joint venture with Berkshire Hathaway and JP Morgan Chase). They’re also cosying up to providers and payers – pharma’s key customers – with customer-facing apps and other data-driven tools to help better match patients to care, encourage preventative care, and measure outcomes. And they’re vying for position – via the smartphone – as the doorkeepers who determine how and where individuals’ access their healthcare. (Both Apple and Google’s parent Alphabet are trying to help consumers gain access to their medical information, currently scattered piecemeal across multiple systems.)
Beyond generating and controlling unprecedented volumes of consumer data, technology groups are coming to FDA with medical-device grade diagnostics and ‘digital therapeutics’ – an entirely new treatment modality that may, in future, impact care pathways in some therapy areas.
The regulators are playing ball. The FDA in September 2018 cleared an electrocardiogram measuring device within the Apple Watch. This, together with an app to detect irregular heart rhythms, may help millions of people to diagnose health issues much earlier, before they become dangerous – and expensive. A couple of months later, the Agency approved Pear Therapeutics’ app-based cognitive behavioural therapy, reSET-O, for opioid use disorder – the first FDA-authorized prescription digital therapeutic, according to the company (partnered with Novartis’ Sandoz). Scott Gottlieb, FDA commissioner, appears committed to ensuring regulations do not inappropriately hold back the momentum towards a “universal digital future in healthcare” and the “re-imagining of healthcare delivery.” He talked in September 2018 about a “modern, flexible, risk-based approach to regulation in this area […] to reduce the time and cost of market entry […] while ensuring patient safeguards are in place” (FDA, 2018).
With regulations no longer an insurmountable hurdle for sector-outsiders, and with technology already transforming most other aspects of our lives, pharma must start considering where and how digital therapeutics will fit within their portfolios.
Digital approaches will not replace conventional therapies. Yet they may complement them, for example as precursors to pharmacological treatment, especially in areas like cognitive disorders or other chronic conditions where drugs on their own are insufficient – or intolerable. Digital therapeutics provide a consumer-friendly angle that conventional pharmaceuticals lack. And, last but not least, their built-in data capture offers insights into customer behavior and needs, informing R&D and providing the foundation for outcomes-based deals.
FDA (2018) Statement from FDA Commissioner Scott Gottlieb on agency efforts to work with tech industry to spur innovation in digital health. September 12, 2018. Available at: https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm620246.htm [Accessed January 8, 2019]