VALIDATION OF DIGITAL HEALTH SOLUTIONS

According to an article published on May 13, 2019 in the journal npj Digital Medicine, despite the growth in the number and capabilities of digital health solutions, the confidence of patients, clinicians, payers, and representatives from industry and the regulatory sphere in medicine remains quite low. A need exists for objective, transparent, and standards-based evaluation of digital health products that can bring greater clarity to the digital health marketplace. Investment in the digital health sector is enormous, with nearly $6 billion in funding in 2017, compared to $4.4 billion in the previous year. For mobile health applications alone, there exist more than 3,000,000 of them, with another 200 added daily.

Currently, no reliable mechanism exists to identify validated digital health solutions. Payers also cannot easily identify quality in this crowded field. Regulatory guidance and oversight are limited, with enforcement restricted to companies that make claims out of proportion to the evidence or where application failures might lead to risks to patient safety. For example, a recent evaluation of 280 diabetes mobile applications found only five associated with clinically meaningful improvement and none were of high methodological quality. A more standardized, objective, rigorous, and transparent process for validation is warranted. Specifically, the validation domains would be: technical validation (e.g., how accurately does the solution measure what it claims?), clinical validation (e.g., does the solution have any support for improving condition-specific outcomes?), and system validation (e.g., does the solution integrate into patients’ lives, provider workflows, and healthcare systems?).

More Articles from TRENDS May 2019

LANGUAGE TRANSMISSION AND TRANSLATION

Examples are provided of how terminological inexactitudes and differences in language can influence understanding and quality of patient care. Read More

PRESIDENT’S CORNER—ASAHP MEMBER FOCUS

Ken Johnson from Weber State University is featured in this issue of TRENDS. Read More

BIPARTISAN HEALTH LEGISLATION

Describes a bipartisan bill in Congress to reauthorize workforce programs under Title VII of the Public Health Service Act and action in the House of Representatives to fund the Departments of Labor, Health and Human Services, Education, and Related Agencies (Labor-HHS). Read More

 

HEALTH REFORM DEVELOPMENTS

Discusses health challenges in rural areas, Medicare for All legislation, and predictive analytics to address social determinants of health. Read More

 

DEVELOPMENTS IN HIGHER EDUCATION

Describes an attempt to correct a mistake in the Tax Cuts and Jobs Act of 2017; re-introduction of the Student Loan Borrower Bill of Rights Act of 2019; a Trump administration proposal to reduce the Pell Grant surplus; and laws passed by states involving student loan companies. Read More

QUICK STAT (SHORT, TIMELY, AND TOPICAL)

  • Pregnancy-Related Deaths, United States, 2011-2015 

  • Severe Joint Pain And Physical Inactivity Among Adults With Arthritis-United States

  • Wireless Sensor System To Monitor Babies In The Neonatal Intensive Care Unit (NICU)

  • Electric Field-Based Dressing Disrupts Bacterial Biofilm Infection To Restore Healing Read More

 

AVAILABLE RESOURCES ACCESSIBLE ELECTRONICALLY

  • Advancing Patient-Centered Care For Individuals With Multiple Chronic Conditions

  • Effects Of Early Care And Education On Children’s Health

  • Addressing Social Determinants Of Health Through Housing Improvements Read More

 

RANDOMIZED CLINICAL TRIALS AND THE WEIGHT OF A SOUL

Although progress has been made in research to measure the effectiveness of clinical interventions, similar lapses found in a study from the early 20th century can be observed in studies conducted today. Read More