
The 19th century was about the Industrial Revolution. The 20th century, the Digital Revolution. As we march closer to the third decade of the 21st century, it is becoming clearer that this century’s revolution will be the Data Revolution. After all, companies are monetizing it, countries are weaponizing it and people are producing it.
In the medical space, this has fostered conflicting aims. The promise afforded by collecting and analyzing digital health data for insights into population health and personalized medicine is tempered by haziness on who owns and leverages that data.
But even as government actors struggle with the question of how to regulate data, technological progress marches on. Given the dizzying array of technological products claiming medical benefits hitting the marketplace, regulatory agencies have had to contemplate, and take, drastic steps to keep up. For instance, in the past two years the FDA has taken the following steps:
- In July 2016, the FDA clarified what constituted a “low-risk” device such as fitness trackers or mobile apps tracking dietary activity.
- In June 2017, new FDA Commissioner Scott Gottlieb outlined his vision for a more streamlined process for digital technologies which moves from a “case-by-case” approach to one that allows developers apply consistent safety standards to innovation.
- Just a month later, the FDA announced the pilot for a digital health pre-certification program for individual companies which allows those firms that demonstrate a “culture of quality and organizational excellence” and the need for minimal regulation to introduce products to be marketed as new digital health tools with less information communicated to the FDA, sometimes with no “premarket submission at all”.
- By September 2017, nine companies, including tech heavyweights Apple, Samsung and Alphabet-backed Verily, had been selected for the pre-cert process.
- On February 13, 2018, the FDA further specified that low-risk products would be evaluated by looking at the firm’s practices rather than the product itself and announced its intent to create a new Center of Excellence on Digital Health which would be tasked with establishing a new regulatory paradigm, evaluating and recognizing third-party certifiers and hosting a new cybersecurity unit to complement new advances.
With this flurry of activity, the FDA is clearly moving toward a principles-oriented and firm-based approach to regulating digital technologies. This means moving away from certifying medtech products to the producers.










