What is Digital Health?

“Digital health” is a term which has been in broad use across the health sector for decades, evolving from earlier terminology such as e-health and health IT. Although the sector has its roots in the health software industry, today’s digital health sector spans much more than e-health, health IT or the implementation of electronic medical records and connected healthcare infrastructure.

The US Food and Drug Administration (FDA), which has taken a leading position in encouraging the adoption of digital health technologies, defines digital health as follows:

The broad scope of digital health includes categories such as mobile health (mHealth), health information technology (IT), wearable devices, telehealth and telemedicine, and personalized medicine.

These technologies can empower consumers to make better-informed decisions about their own health and provide new options for facilitating prevention, early diagnosis of lifethreatening diseases, and management of chronic conditions outside of traditional care settings.

From mobile medical apps and software that support the clinical decisions doctors make every day to artificial intelligence and machine learning, digital technology has been driving a revolution in health care. Digital health tools have the vast potential to improve our ability to accurately diagnose and treat disease and to enhance the delivery of health care for the individual. Digital tools are giving providers a more holistic view of patient health through access to data and giving patients more control over their health. Digital health offers real opportunities to improve medical outcomes and enhance efficiency.2

Working from the FDA’s definition, it is clear that the digital health sector, when viewed holistically, comprises proven, evidence-based healthcare systems and interventions that are driven by digital technologies – technologybased products and services that treat, diagnose, cure, mitigate, and/or prevent disease.

A recent report published by HealthXL, the intelligence platform and community for digital health, and Node Health expanded upon the sector definition to provide further clarity over certain types of products within the broader digital health remit, providing a view as to how different types of digital health technologies require different levels of evidence and attract different levels of regulatory oversight:3

Software (and hardware) that delivers therapeutic intervention which:

Digital Therapeutics

• Prevents disease

• Treats disease

• Manages disease

• Mitigates disease

• Improves health function l Digital health includes technologies, platforms and systems that engage consumers for lifestyle, wellness and health-related purposes, capture and store health data, or support operations. They do not typically require clinical evidence or regulatory oversight. l Digital medicine includes evidencebased software and/or hardware products that measure and/or intervene in human health. They all require clinical evidence and are likely to require regulatory approval. l Digital therapeutics deliver evidencebased therapeutic interventions to prevent, manage or treat a medical condition. They all require clinical evidence and real-world outcomes data and must be cleared by regulatory bodies to support their claims of safety, efficacy and intended use.

This approach is useful as it clearly illustrates how certain technologies attract greater development risk, have higher evidence requirements and attract different levels of regulatory oversight. The following graphic –adapted from HealthXL to reflect what we have observed in the market –illustrates the different levels of risk and impact within the digital health sector.

Commercial Evidence

+ Clinical Evidence

+ Real World Evidence

Digital Medicine

• E-assessments

• Digital companion

• Enterprise support

• Remote patient monitoring

• Decision support software

• Digital diagnostics & biomarkers

Digital Health

• Health IT

• Clinical care admin & management tools

• Telehealth

• Decision support software

• Electronic medical records

Commercial Evidence + Clinical Evidence

VALUE PATIENT IMPACT

Commercial Evidence