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.
At this year’s annual HIMSS conference, a common topic of discussion was around how to continue to bring the technological and medical aspects of healthcare together to evolve, grow and support one another.
Each semester, I share with my Health IT students the many reasons that it is such an exciting time to be in healthcare. As we transition from a volume-based to a value-based incentive model, healthcare is going to look significantly different by 2020. This transformation is no longer a wish, it is no longer an option; it is our collective future. People who were previously one-foot-in and one-foot-out will be fully planted in the value-based healthcare model.
Non-stress tests (NSTs) are the current standard of care for monitoring high-risk pregnancies. Intended to reduce the risk of stillbirths, these tests are for those who have one or more risk factors, whether they be maternal, fetal or obstetric complications.
Currently, these tests can be very time-consuming for patients. NSTs involve attaching the mother to fetal and contraction monitors to watch the fetal heart rate tracing and uterine activity. However, many rural and remote areas don’t have ready access to NSTs. Consequently, mothers sometimes travel up to several hours each way to get to our facility for their NST appointments once or twice a week. Once they arrive, there’s the usual wait time, the 30-60 minute testing process, plus an additional wait time for the test to be interpreted by a staff member and a clinician. These appointments, on top of any additional prenatal visits the mothers have scheduled, can therefore add up to a considerable amount of time, even for patients who live nearby.
When it comes to mHealth, most industrialised nations such as the U.S. and Europe have a head start. Money for healthcare technology investments is available, the infrastructure is in place, and most of the population is already engaged in the healthcare system.
As a country of about 52 million people, South Africa shares many characteristics with its larger brethren. There is a mix of public and private healthcare providers and health insurance plans, physician shortages in key areas, and South Africa is beset by many of the same chronic diseases that industrialised countries face (cardiovascular and obesity-related diseases, diabetes, etc.).
The key to successful health care technology is making sure it improves both the patient experience and the quality of care. While technology is sometimes seen as a barrier to human connection and interaction, the right tools can transform the health care experience for the patient. At Dignity Health, our focus for 2015 is centered on making population health a reality by looking toward the ambulatory side of care. The mobility strategy we put in place in 2014 is enabling us to empower our providers and care teams with telehealth solutions so they can have alternate ways to connect with and care for their patients.
There are more mobile devices than there are people on the planet. Many of us look at our phones more than 70 times a day. We bring them with us everywhere we go – to the movies, to our children’s soccer games and to work.
Many of us even have work environments that allow us to ‘bring your own device.’ If that is not an option, our work devices (thankfully!) are looking more and more like our personal devices. And in healthcare, we are now successfully addressing challenges to building mobile healthcare solutions that support our natural use and knowledge of these devices in our life flow.