Digital health regulatory and policy considerations

Abstract The objectives of this chapter are to familiarize the reader with the role of government policy, regulatory, and legislation particular to digital healthcare and medical products. Healthcare is highly regulated and serves as one of the largest industrial sectors of the global economy. It accounts for approximately $10 Trillion dollars spent annually and includes a complex interrelated web of businesses, vendors, insurers, providers, organizations, and most importantly, patients. Healthcare regulations originate from decades old frameworks, often ill-suited for the rapid advancement of technological innovation and growth. Digital health has become a disruptive force currently changing significant aspects of the business of healthcare. The pace of innovation has to be balanced with minimizing risk for patients. This chapter briefly introduces the reader to how the US system of government is organized, how laws are created, how rules are derived from law, and how governmental agencies implement those laws, draft regulations, and set policy. It specifically highlights several agencies within the US Department of Health and Human Services that affect the development, reimbursement, and ultimately the adoption of digital health. It closes by describing the international regulation of digital health.