This past year, 2017, has been a challenging year for many industries, and healthcare is certainly no exception. Not only are there major challenges connected to an increasingly aging population and outdated healthcare infrastructure, but the industry is also adapting to the policies associated with a new presidential administration. While technology will continue to be a key part of the future of healthcare, one of the biggest changes will be a shift in mindset from mobile technology to mobile patients.
The number of quality initiatives is rapidly rising in the healthcare industry as stakeholders shift their focus toward the value of patient care. In addition, with the recent implementation of the Medicare Access and CHIP Reauthorization Act (MACRA), the rules surrounding healthcare reimbursement are being rewritten, incentivizing healthcare providers to prioritize the quality of patient visits over the quantity.
Historically, it has been difficult to achieve consensus on defining quality; therefore, it was not consistently measured. MACRA provides tools to assess quality of care, and lays the foundation for a future in which payers and providers must collaborate in new ways driven by patient data.
Most physicians have long enjoyed the benefits of Bring Your Own Device (BYOD) policies. As health systems focused on ensuring doctors had access to state-of-the-art health IT to monitor their patients when they couldn’t be at the bedside, the quality of tools and pace of adoption for nursing solutions did not keep up. In some situations, nurses received bulky phones that could only be used within the walls of the hospital, while physicians needed to download specific apps on their own devices to receive calls from the nurses’ devices. Technical difficulties were frequent. In other situations, health systems tried rolling out solutions to nurses that had been used successfully by physicians. Unfortunately, those solutions were not always conducive to nurses’ workflow.
As we celebrate National Health IT Week, it is incredible to realize how health technology tools are transforming every facet of patient care. From telehealth, to 3D printers to artificial intelligence, the explosion of personalized health devices redefines the dynamics of patient treatment and interactions.
However, we still fall short in comparison to other industries, particularly in terms of consistent patient information access, and the lack of incentive for industry collaboration to achieve smooth, interoperable data transfers. This week, we strike a balance between applauding our progress, yet refusing to rest on our laurels.
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.