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Speed up your digital health strategy today – your healthcare regulators already are!

Nardev Ramanathan, Ph.D., Analyst
April 29, 2019

Healthcare regulators have, in the past few years, been reviewing and revising their guidelines on how to better enable health technology developers to pursue innovation, without having regulation and bureaucracy hamper progress. And here’s why - unsustainable healthcare costs in recent times have reached a level where chronic diseases are costing the planet trillions of dollars a year to manage. And don’t just take our word for it – these two anecdotes below should serve as stark reminders of this fact:

  • Finland’s entire government quit just weeks before its elections, explicitly stating that it is doing so due to an inability to deliver on healthcare reform plans it promised. This news is even more shocking coming from a developed economy renowned for a strong tradition of innovation that gave us the likes of Nokia and Angry Birds.
  • From a chronic disease care view, diabetes care alone costs the planet $1.3 trillion dollars a year to manage, which is slightly more than 1% of the world’s GDP today. This is just one disease!

Traditional models of care are clearly not enough. Digital health and precision medicine are two ways forward. We have briefly touched on precision medicine and genomics in a blog post last year and will cover more on this topic in future blog posts. In this post we will speak about the changes in the regulatory environment, particularly around digital health, and why you should start acting now. We will highlight a few healthcare regulators here from some of the largest economies in the world and how they have been revising their guidelines to enable new and innovative digital health solutions to reach the consumer and enable improved health outcomes.

U.S. FDA – The U.S. FDA have long been criticized for being slow and difficult to deal with when it comes to approval of new medical treatments, and more so with the advent of digital health and precision medicine. However, the appointment of Scott Gottlieb as the U.S. FDA Commissioner in 2017 turned the U.S. FDA to one of the most progressive regulators in the last couple of years, inspiring many other regulators in other parts of the world to rethink their approach to supporting innovation in digital health.

One of the first major guidelines proposed was to approve selected digital health developers rather than a specific product itself. The rationale behind this was simple. Approving each individual application is not sustainable from both the applicant (continuous individual applications submitted and the time to hear back on a decision) and the regulator (resources and manpower to review the applications. More so with digital tools that are constantly being reiterated, optimized and upgraded – by the time the product is approved, it may very well be obsolete and not relevant for the market anymore. So the U.S. FDA came up with the pre-cert program which approves the developer rather than product, so long as the digital health developers show commitment to monitoring the real-world performance of their products once they reach the market. The current list includes big name developers like Apple, Fitbit and Samsung, but the FDA is constantly reviewing this list, perhaps your organization could be next on the list.


U.K.’s MHRA – The Medicines and Healthcare products Regulatory Agency (MHRA) is an executive agency of the Department of Health and Social care in the United Kingdom that carries out the analogous role of the U.S. FDA in the U.K. Despite all the press around Brexit, the U.K.’s healthcare system have been quick to adopt digital health and genomic medicine into clinical practice. The MHRA has stood alongside U.K. National Healthcare System (NHS) and supported its initiatives in recognizing the potential of digital health to bring down unsustainable healthcare costs. It has developed guidelines way back in 2016 for digital health apps, making it one of the first in the world to do so, even before the U.S. FDA.  In addition, the U.K. NHS Digital and MHRA have joint funding programs to support new and innovative initiatives, especially around gathering datasets and developing the tools to analyse them to support better care. Could your organization be the next partner for the U.K in healthcare?

India’s CDSCO – The Central Drugs Standard Control Organization is the national regulatory body analogous to the U.S. FDA in India. The CDSCO is another major organization known to be notoriously bureaucratic, but in just the last few months, a couple of major announcements suggest that the healthcare regulator from the world’s largest democracy is now taking a progressive stance as well.  CDSCO has long been supportive of the digital transformation of clinical trials and pharma manufacturing process to help speed up these processed to bring new treatments faster to the populace. With digital health, it is expected that the CDSCO will engage more stakeholders such as Abbott, who’ve just announced its digital services in India, the first country it is doing so at a national scale. The CDSCO has in fact changes its scope so much, the Health Ministry is now taking nominations for a name change for the organization. Suggestions anyone?

We’ve shared three regulators from major economies in the world, but there are others as well that are rapidly adopting new guidelines, as unsustainable healthcare costs plague all corners of the earth. So, it’s time to rethink your approach to digital health. Did you have a plan before, but decided to just shelve it because regulatory hurdles were just too prohibitive? Time to revive those plans again, the world’s healthcare system is your oyster!