During the Covid-19 pandemic, digital health technologies transformed the way that many of us received health care, supercharging the uptake of digital tools such as telehealth platforms, mobile symptom trackers, and remote monitoring. However, the whole-scale adoption and impact of digital health technology in national health systems around the world has still not yet fully materialized. A critical reason is that they often lack the necessary scientific evidence to back the range of benefits--from improved health outcomes for patients to better cost-benefit outcomes for payers such as insurance companies and health care providers--that its manufacturers claim they can deliver. A recent study by healthtech seed fund Rock Health and Johns Hopkins University demonstrated the extent of the problem. The researchers reviewed the associated clinical trials, regulatory claims filings, and listed outcomes by 224 healthcare companies.

Prior to the coronavirus pandemic, the use of digital technology in healthcare was on a steady rise; however, the pandemic has spurred rapid development of digital health technology as well as rapid adoption and utilization of that technology in the industry. Digital health holds the promise of increased accessibility to high-quality, patient-centered care that can also increase patient engagement and reduce costs. However, the full realization of this promise may be threatened by policy and regulation that is failing to keep pace with and encourage this evolution. There is no universally accepted definition of digital health. In fact, researchers studying the definition recently came across no fewer than 95 published definitions for the concept of digital health.1 There were, however, some clear patterns: there is an emphasis on how data is used to improve care; there is a focus on the provision of healthcare, rather than the use of technology; and the definitions tend to highlight the well-being of people and populations over the caring of patients with diseases. As used in this article, digital health encompasses the use of digital tools and technologies to improve and manage an individual's or a population's health and wellness.

The healthcare sector must become more proficient in deploying automation and enablement technologies as the industry faces an increasingly demanding user base and moves toward a value-based care strategy, according to analyst firm EY's latest health report. WHY IT MATTERS The report highlights the connections healthcare players need to move the industry forward in the face of digitization, and explores how redefining value in healthcare is leading to new ways of delivering care. For consumers and physicians, healthcare systems lag in introducing digital health technologies, and the report notes the major challenge for health systems around the world is how to unlock the power of digital health technologies as an enabler of real system change. In addition to a "digital backbone" that will eventually transform the patient's end-to-end consumer experience, digital tools will also start to move the location of more care into the user's home. The report also pointed out upcoming 5G network capabilities will help power the Internet of Things (IoT) devices and connectivity requirements needed to provide at-home care services and more sophisticated mobile and telehealth technologies.

From wearables for health monitoring and self-care apps to machine learning analysis of medical images, the potential of digital technologies to revolutionise healthcare is a leading aspect of modern healthcare. The rapid growth of digital devices, software and machine learning technologies means that the medical device sector is changing. Effective, responsive regulation of digital health technologies requires sound understanding of their technical basis and underlying concepts – but even with this knowledge, identifying where they fit within this complex and evolving regulatory environment is no easy task. A major new report from the PHG Foundation, Algorithms as medical devices, describes how medical device regulation applies to digital health, including machine learning. Based on extensive research and expert stakeholder discussion, this new report is an important resource for manufacturers, software developers, regulators and policy makers working in digital health, and offers policy recommendations for improving the regulation of digital medical devices.

Digital technologies are constantly evolving and finding new applications in healthcare, even while the industry is struggling with adoption and'digital transformation'. Each year new applications emerge, but the underlying technologies driving them remain the same. For 2019, we asked companies around the world one basic question: "Please indicate the key technology which you believe will have the most profound impact on the healthcare industry during 2019?" Of course, these respondents are distributed across widely different sectors – pharmaceuticals and biotechnology, medical devices, medical imaging equipment, in-vitro diagnostics, remote patient monitoring, healthcare IT and digital health solution providers – but excluding care delivery settings such as hospitals and other facilities. This means that these technologies are being viewed through a different lens, depending on which sector the respondent belongs to.

In this News Insight from HIT Consultant, Dale Van Demark discusses how we may be on the brink of a revolution in healthcare driven by AI. For more insights on how healthcare providers can enhance the patient experience through technology today, download our in-depth guide. An Accenture report was released at HIMSS18 with a bold prediction: the healthcare artificial intelligence (AI) market may hit $6.6 billion in the next three years. In 2014, that number was just $600 million, meaning the AI healthcare market could see an eleven fold increase in value in less than a decade. The survey showed that as of 2018, one in five U.S. consumers have already used healthcare services "powered by artificial intelligence," and many are open to AI clinical services, like home-based diagnostics (cited by 66 percent of respondents) and virtual health assistants (61 percent).

In the last few years, there has been a growing presence of artificial intelligence technologies or AI in healthcare. Though AI will not displace human relationships in the delivery of care, it will provide for an unchartered transformation of the healthcare industry. As highlighted in Trend 5: The Uncharted from the Accenture 2017 Digital Health Tech Vision, such a potentially massive change will demand a dramatically different governance structure from what we see today. The recent announcement of the Software Pre-Certification Pilot Program by the Food and Drug Administration (FDA) is one step in that direction. The FDA's stated purpose of the program is to balance the reduced time and cost of market entry for digital health against patient safety and quality of care.

Finally, FDA has embarked on an ambitous project to re-design its oversight of digital health technologies to focus more on the developer. This continues an effort by FDA to improve and accelerate its review process associated with digital health technologies, which included guidance on mobile medical apps. While FDA has been subject to criticism in these efforts by industry groups, the effectiveness of these efforts to balance a desire for a quicker and more certain clearance process and protecting the public remains to be seen.

The 21st Century Cures Act amended the term "device" to exclude clinical decision support software, which can deploy AI and ML technologies. While the requirements associated with the exclusion are rigorous, the legislation represents strong legislative support for the development of AI and ML healthcare technology. FDA has also cleared some AI-based medical devices, and there is no reason to believe this will not continue through 2018. Finally, FDA has embarked on an ambitous project to re-design its oversight of digital health technologies to focus more on the developer. This continues an effort by FDA to improve and accelerate its review process associated with digital health technologies, which included guidance on mobile medical apps.

The future of cardiovascular care will be transformed by advances in artificial intelligence, digital health technology and mobile devices as a means to prevent and treat heart disease, according to several articles published June 4, 2018 in a Journal of the American College of Cardiology Focus Seminar on the Future Technology of Cardiovascular Care. As the type and breadth of data available to cardiologists and the cardiovascular care team continues to grow more sophisticated, physicians are increasingly being asked to provide more rapid and personalized interpretations of data to their patients. One solution to providing this level of personalized medicine efficiently is artificial intelligence, also known as machine learning. In the review article Artificial Intelligence in Cardiology,[1] researchers analyze select applications of artificial intelligence in cardiology and identify how the specialty could incorporate more artificial intelligence in the future to enhance the capabilities and experiences of clinicians and patients. "(Artificial intelligence) has clear potential to enhance every stage of patient care -- from research and discovery, to diagnosis, to selection of therapy," said Joel Dudley, Ph.D., senior author of the review and director of the Next Generation Healthcare Institute at Mount Sinai. "A key next step to incorporating artificial intelligence into cardiology is to align available data and technologies with clinical and business use.