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.
Over the past couple of years, there have been around 200 merger and acquisition (M&A) deals in the healthcare IT space, driven by high enterprise value and the sheer size of the industry. 49 deals came together in the first quarter of this year alone. These numbers make health IT the highest performing industry in terms of M&A activity in the consumer and retail space, and the second highest in the infrastructure/industrial space.
Between 2018 and 2019, we will see an insatiable need for increased health IT interoperability, with providers putting increased pressure on health IT vendors to deliver. This pressure – combined with the shift brought on by new regulations like MACRA around performance, measurement and outcomes – will drive one of the biggest M&A pushes we’ve seen in the health IT industry.
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.
The role of a nurse is a complex one. Not only is this individual responsible for the physical bedside care of multiple patients, but may also be called upon to offer emotional support for patients and their families. While this is an absolute honor and a privilege, it can also be emotionally draining and lead to burnout syndrome or compassion fatigue. In order to ensure that patients receive the highest quality care, we must make sure that nurses have support for their own emotional well-being.
Care delivery best practices are constantly changing to optimize efficiency and safety, and look considerably different compared to just a decade ago. The digital healthcare transformation has ushered in promising opportunities to use technology to improve nurse and clinician workflows, monitor patients remotely, and provide secure paths for communication between care team members.
As we head into HIMSS 2017, the movement toward precision medicine is at the top of the agenda. The idea of using data to customize care for patients is not new; however, with the passage of the 21st Century Cures Act late in 2016, what was once a far-off dream now seems closer to reality.
But are we really that close? Unfortunately, the answer is no, unless we address the key barriers to success: interoperability and cybersecurity.
Across the country, health care organizations are re-envisioning how to deliver care. Major health systems like Lahey Health are seeking out new solutions that allow us to transition from episodic care to wellness – minimizing the impact of disease and managing the health of populations more effectively. At the same time, patients continue to demand more from their care providers. We now must bring care to patients at the time and location of their choosing, and this is the beginning of the consumerization of healthcare. These shifts require technology that can provide more comprehensive and context-aware views of patients’ data, support for collaborative care across the continuum, and allow health systems to scale their delivery of care in new ways. Consequently, CIOs face constant challenges to seek out the most effective technologies that will ensure an organization’s vision can come to fruition.