Why there is no beta in health care

By Anonymous

Why there is no beta in health care

In less than a week, the digital health market received both an unprecedented endorsement and a biting criticism. Earlier this month, England’s National Health Service (NHS) made an announcement to provide millions of patients in the U.K. with free tech for conditions like heart disease and diabetes. And here in the U.S., just days before, the CEO of the American Medical Association (AMA) described the digital health industry as peddling apps and devices that "impede care, confuse patients and waste our time."

The disparity between these perspectives shows an industry at a crossroads. Facing equal parts potential and skepticism, there is a huge opportunity for the entire industry to rise to the occasion and truly deliver on the promise of digital health innovations.

With this new model, the NHS becomes a global leader shaping health care innovation. By covering the costs for promising direct-to-consumer technologies and putting them in the hands of patients and doctors, it is delivering a system that can dramatically improve patient care while reducing costs.

The right path forward for the digital health industry begins with a significant shift in the Silicon Valley mindset: "Move fast and break things" just won’t work.

The impact of this plan on the U.S. and other markets will be tremendous, as it provides a model for any national health system and risk-bearing private provider to screen large populations for life-threatening diseases and catch and treat them much earlier.

Take heart health, for example: Heart disease is the leading cause of death in the U.S., with arrhythmias (abnormal heart rhythms) alone killing 500,000 in the U.S. annually and 100,000 in the U.K. The Arrhythmia Alliance, however, estimates that 80 percent of these deaths could be avoided through better diagnosis.

Large and prestigious U.S. health care organizations are already adopting digital health technologies. In fact, health care providers all over the world are validating digital health solutions and demonstrating this ability to improve outcomes and reduce costs. Professor Ben Freedman from the University of Sydney (AU) deployed AliveCor’s Kardia Mobile heart monitor in a large-scale patient screening and was able to detect previously undiagnosed atrial fibrillation — the most common arrhythmia — in 1.5 percent of people over 65. This made it possible for caregivers to proactively initiate stroke-prevention therapy for those patients.

While there are many examples of how new technologies are helping manage life-threatening diseases, the AMA remains cautious for a reason. The explosion of health care technologies in recent years include some that have not been properly tested or evaluated, and the high-profile cases have cast a shadow over the entire digital health industry.

These products and services demonstrate the dark side of the intersection of technology hype and health care. Whether the companies made unfulfilled promises, lacked transparency about the technology’s limitations or simply didn’t follow regulatory requirements, some of these products have the potential to diminish rather than improve care, breaking the most important principle of medicine: First, do no harm. Direct-to-consumer blood tests, for example, when applied to a large population, carry an alarmingly high false-positive rate.

The right path forward for the digital health industry begins with a significant shift in the Silicon Valley mindset: "Move fast and break things" just won’t work. When a product directly relates to human health, following regulatory requirements needs to be a core part of the strategy from day one.

It’s time that we stop viewing regulatory bodies as obstacles and start viewing them as valuable partners.

What has been seen as a burden needs to be seen as a benefit. It’s time that we stop viewing regulatory bodies as obstacles and start viewing them as valuable partners. This is a mindset that should be adopted across a company’s entire team — from board to CEO to VC to developer.

Health care is not a market that can be hacked. However, the same regulations that may seem slow and frustrating are part of what makes the opportunity so big — both for the impact technology can have in improving lives, but also for creating a truly valuable company.

We are lucky to operate in a country that values quality of care enough to have agencies in place to keep standards high. When companies operate in partnership with these agencies, the dynamic will also keep the standard of innovative health technologies high and boost the value of every digital health company. AliveCor’s path to market is a case in point — an overnight success that took years. We started by putting the patient and the caregiver at the center, working with cardiologists, leading hospitals and clinics, participating in more than 60 research papers and clinical studies, investing in a relationship with the FDA, and working for more than three years with the NHS.

It’s a process that requires rigorous testing, clinical trials, an investment in regulatory clearance and an understanding that there is no beta in health care. If our industry can get this right, we have an opportunity to truly deliver on the promise of medical technology. The keys to it all are innovation, humility, patience and commitment. Does that sound like Silicon Valley? I believe it can.

Vic Gundotra is the CEO of AliveCor, the leader in FDA-cleared ECG technology for mobile devices. Prior to joining AliveCor, he spent nearly eight years at Google, where he served as an SVP from 2011 until April 2014, heading up mobile engineering and focusing on on the company’s social initiatives and mobile application development. Before Google, Gundotra was with Microsoft for 15 years, and was recognized on MIT’s annual list of innovators under 35 for his work there. Reach him @GundotraVic.