Like an anxious, expectant father, pundits and reporters just can't wait for the birth of "real" digital health, with all the hype and promise of a new life for sick care. Their commentary and reporting, however, reflects some fundamental misunderstandings about digital health:
1. "Digital health" is a term that has many definitions. Mine is the use of information, communications, and other interface technologies to diagnose, prevent, treat, and manage disease in individuals and populations.
2. Digital health products and services fall into two broad categories as defined by the FDA: medical devices or non-medical devices. In large part, the intended use defines the category. A medical device is an instrument, apparatus, implant, in vitro reagent, or similar or related article that is used to diagnose, prevent, or treat disease or other conditions, and does not achieve its purposes through chemical action within or on the body. Whereas medicinal products (also called pharmaceuticals) achieve their principal action by pharmacological, metabolic, or immunological means, medical devices act by other means like physical, mechanical, or thermal means.
3. Digital health describes a range of technologies with an array of intended uses.
- Remote sensing and wearables
- Data analytics and intelligence, predictive modeling
- Health and wellness behavior modification tools
- Bioinformatics tools (-omics)
- Medical social media
- Digitized health record platforms
- Patient-physician patient portals
- DIY diagnostics, compliance and treatments
- Decision support systems
4. Not all digital health products and services diffuse at the same rate. Each has a semi-autonomous ecosystem with varying business models and drive or interfere with adoption and penetration.
5. Rules enable ecosystems. The rules are constantly evolving, e.g. in telemedicine, cybersecurity, social media, and EMRs that subsequently drive new products and services. One rule does not necessarily apply to all digital health applications or uses.
6. Ecosystems enable business models. A business model describes how a business entity creates, develops, deploys and harvests value. It is an ongoing process that differs from one digital sub-sector to another. Models are not the same for every digital health application and they change daily.
7. Business models drive innovation. Innovation describes doing something new or something old in a new way that results in a significant user defined multiple of value when compared to a competitive offering. Some value multiples are minimal. Others are significant. Many digital health solutions have delivered minimal value. Others are solutions looking for problems.
8. Digital health describes a range of facilitating technologies. There is no one digital health technology. Similar to describing energy based medical devices, they can use different forms of energy and interventions to achieve their intended effect. EMRs are different than social media. Lasers are different from ultrasound devices.
9. Sick care ain't Uber. In many ways, Internet and media technologies are the tail wagging the sick care dog. They were not originally intended for sick care applications. Because of the attractiveness and opportunities in sick care, however, non-sick care entrepreneurs with consumer products and media backgrounds decided to stick their noses under the sick care tent. But, sick care is different from many reasons. The results in many instances have been disappointing.
10. Most digital health products are snake oil. Digital health products and services need to be not just technically and commercially validated, but clinically validated as well. Few are. Consequently, like a drug or device that has not been demonstrated to be safe and effective, they are potentially dangerous.
As digital health evolves, so will clarity about the domain. Reporters and commentators have an obligation to their readers to get them the "real" story about when digital health will get "real" and how it will impact their health.
Arlen Meyers, MD, MBA is the President and CEO of the Society of Physician Entrepreneurs at www.sopenet.org