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.
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 
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.
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 
Mobile Health Matters 