The U.S. Food and Drug Administration (FDA) recently released “A Working Model v.1.0” for its Software Precertification Program, which is aimed at organizations that design, test and monitor software products used for medical purposes (“Software as Medical Device” or “SaMD” products). The goal of the Software Precertification Program is to encourage innovation in digital health technologies by streamlining regulatory approaches while ensuring patient safety and device effectiveness.
The U.S. Food and Drug Administration (FDA) is increasing its capability to harness the power of big data – or more specifically of the “real world evidence” (RWE) – to assess the safety of medical products that are approved for the U.S. market. To that end, FDA is expanding its Sentinel System so that by the end of 2023 it would represent “a transformative, multi-purpose national data and scientific resource center for evidence generation that a wide array of stakeholders use to inform all aspects of healthcare decision making,” according to the recently released Sentinel System Five-Year Strategy.
The National Health Service (NHS) oversees health services in England, and under that government’s direction sets strategic objectives for the health care system as a whole. The other constituent countries of the United Kingdom (UK) – Scotland, Wales and Northern Ireland – similarly have their own public-health agency each. Any UK resident may obtain health services through any of these independent organizations – either for free or at a much lower price than through a private provider.
Last year, NHS celebrated its 70th anniversary. The milestone prompted a national conversation about the role and future of that organization. In part in response to that debate, the agency prepared and recently released “The NHS Long Term Plan,” outlining its vision for servicing public health in the next decade. A previous strategic document, “NHS Five Year Forward View” (2014), created a foundation for the current planning by setting in motion some of the initiatives that are now being projected to be spread to the entire system.
Health care is one of the most complex and socially impactful areas of digitalization. Ensuring cybersecurity of health care operations, therefore, is of paramount importance – because potential vulnerabilities may lead not only to financial or technical exposures, but to lapses in life-or-death situations for patients.
To assist practitioners with education and guidelines, and in pursuance of Cybersecurity Act of 2015 (Public Law 114-113), Section 405(d), the Department of Health and Human Services created a “405(d) Task Group” in May 2017, involving, more than 150 health care and cybersecurity experts. The result of their collaborative work became a voluntary guideline entitled “Health Industry Cybersecurity Practices: Managing Threats and Protecting Patients,” which was released at the end of 2018.
Expanded use of Electronic Health Records (EHRs) is an integral component of the ongoing modernization of the U.S. health care system through digitalization. Among the anticipated advantages of using EHRs are improvements in patient care (e.g., through faster access to relevant information and consequently improved care coordination), increased patient engagement, as well as reduction of medical errors and cost savings. On the other hand, implementing EHRs in a sustainable and legally compliant way requires upfront investment in hardware, software, training, workflow restructuring, as well as management of risks unique to electronic records, such as vulnerability to malicious interference. When EHRs are combined with mobile platforms, the cybersecurity risks multiply. Addressing this latest challenge can be daunting, both for medical practices and EHR product providers.
Health care technology, particularly digital medicine, promises great new capabilities that will improve outcomes and reduce overall costs and time constraints. Digital medicine encompasses a broad-range of technologies, from technologies used to record, retain, and manipulate health data (i.e., Electronic Health Records aka., EHRs) and thereby make it more useable and amenable to analysis; to actual tools in clinical care (i.e., medical imaging, wearable sensors) that can measure physiological parameters or patient activity and facilitate clinical care and decision-making.