The document summarizes several papers on digital medicine published in 2019. It discusses the potential but also limitations of digital health companies to impact disease burden and costs. A large Apple Heart Study was able to identify a small number of irregular pulses using a smartwatch. While digital portals can promote health equity, more work is needed on health literacy and social determinants of health. Real-world data will be important for evaluating digital tools as technologies evolve rapidly. Validation, regulation and ethics must be considered to realize mobile health benefits while avoiding harms.

1. The State of the Evidence
in Digital Medicine 2019
Digital Medicine Conference 2019

2. Top-Funded Digital Health Companies And Their
Impact On High-Burden, High-Cost Conditions
Health Affairs, January 2019
• identified the twenty top-funded private US-based
digital health companies to analyze their products
and services, related peer-reviewed evidence, and
the potential for impact on patients with high-
burden conditions
• digital health companies have not yet demonstrated
substantial impact on disease burden or cost in the
US health care system.
• Limitations – chose top funded, some of which have
been acquired and not those focused on evidence.

3. Large-Scale Assessment of a Smartwatch to
Identify Atrial Fibrillation
Apple Heart Study – NEJM – Nov. 2019
• recruited 419,297 participants over 8 months
• 2161 participants (0.52%) received notifications of
irregular pulse
• pragmatic study design provides a foundation for
large-scale pragmatic studies in which outcomes or
adherence can be reliably assessed with user-
owned devices

4. Leveraging Advances in Technology to Promote Health
Equity – Medical Care – June 2019
• Minorities and persons of less privileged
socioeconomic status are just as likely to utilize
portals
• Population health is a path to health equity, eg,
hypertension in minority communities
• Need more awareness of health literacy issues and
other Social Determinants of Health

5. The reproducibility crisis in the age of digital medicine
npj Digital Medicine – January 2019
• Part of a broader crisis in reproducibility in medical
research
• Reproducing a study can be prohibitively costly
• Peer review is not enough
• As more data and computing power become
cheaply available to the field of digital medicine,
reanalysis will be less costly
• AllofUs NIH program and eMERGE bridge data gaps

6. Frontiers in Medicine: Mobile Devices and Health
NEJM – September 2019
• Discusses how passive and active sensing as ways of
collecting patient reported outcomes
• Emphasizes the importance of digital biomarkers,
digital therapeutics and diagnostics
• Through the use of FHIR, data can be integrated into
clinical care
• Validation, regulation and ethics need to be considered
• Mechanisms of mobile health benefits and harms are
detailed.

7. Health Regulation for the Digital Age — Correcting the
Mismatch – NEJM , November 2019
• Notes the need to update HIPAA to deal with
technology like voice
• Digital tech has simultaneously undermined some
core presumptions of health care regulation.
• regulatory policy could be tailored to the needs
of digital medicine. Interagency communication on
FDA regulation and CMS privacy rules are an example
• Should not prohibit best practices to ensure benefit

8. Evaluating Digital Health Tools—Prospective,
Experimental, and Real World – JAMA Internal Med
February 2019
• use of experimental studies of DHSTs has been
increasing and that at least 70% were enrolling or
completed by the end of 2017
• evaluations remain a challenge because DHSTs rapidly
evolve
• most of our understanding of safety or effectiveness is
likely to be made based on real-world evidence and
performance data
• In some situations, real world data prompt a
prospective clinical trial

9. Digital Medicine: A Primer on Measurement
Digital Biomarkers, May 2019
Examples of Digital Measures in Clinical Care
• Recovery, performance, and treatment selection
• Real-time safety monitoring
• Treatment adherence
In Clinical Research
• novel endpoint
• medication adherence
• Safety events
• Screening, enrollment

10. Navigating the Digital Health Ecosystem to Bridge the
Gap from Innovation to Transformation: A
NODE.Health Perspective on Digital Evidence
Why Is Evidence So Much More Important in Healthcare
than in Other Industries?
• People’s Lives Are at Stake
• Healthcare Is a Slowly Changing Industry
• Clinical Evidence Alone Is Not Sufficient
• Many Physicians Are Trained with an Academic Rather
than Pragmatic Mindset
• Digital Solutions Are Overcoming “Snake Oil” Labeling
• Need to understand the digital health ecosystem