Software as a medical device (SaMD) is defined by the International Medical Device Regulators Forum as “software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device.” SaMD is developed at a much faster pace than traditional medical devices, and may require frequent updates, as opposed to hardware devices that typically are updated every few years. While SaMD and medical devices are clearly different and evolve at completely different paces, the same regulatory approval process currently applies to both types of technology. Using the same process for both is akin to forcing a square peg into a round hole – it is not going to work because one size does not fit all, especially in healthcare.
This is a watershed moment in healthcare. New technologies are constantly in development to help treat and prevent previously incurable conditions, and improve current processes. From leadless pacemakers to mobile applications that advance telehealth access, digital innovation is at an all-time high. The problem is that our current speed of regulatory approval for these innovations simply cannot keep up.
While many groundbreaking technologies are being created, their full promise is not being realized because they are not being approved quickly enough to be implemented and adopted by health systems. The FDA regulatory process has long been a matter of contention. However, now that the rate of innovation is increasing, things need to change accordingly. By working together to streamline this regulatory process, technology will arrive to the market faster and propel the healthcare industry forward.
For over a year, the US has spent much of its time wondering who would be the next Commander-in-Chief, and what the implications would be with a Hillary Clinton or a Donald Trump presidency. Now that we have our answer – that Donald Trump will be leading the nation for at least the next four years – people across all industries are wondering how a new administration will impact their business.
What exactly will this new administration mean for healthcare IT? The space is relatively bipartisan. People on both sides of the aisle realize that technology can enable better patient care in a cost-effective way and has the ability to be far-reaching, providing better care options to those in rural areas. But there’s no doubt that the most recent election will drive some changes in 2017.
This week, I had the privilege to present at the Energy and Commerce Subcommittee on Commerce, Manufacturing and Trade Hearing that took place in Washington, DC. As part of the “Disrupter Series: Health Care Apps” hearing, leaders in the healthcare industry discussed how mobile applications are disrupting the ways in which doctors and patients engage in the health care system and impact the affordability, accessibility, and delivery of care.