Take this App and Call me in the Morning

Smartphone & pills (M) image - istock id177747640.jpg

Hospitals often ask how they can increase patient engagement to improve outcomes. Adding care managers is the favored approach, and certainly provides benefit. But at what cost? And how can a health system scale these finite clinical resources?

One answer is technology, specifically digital therapeutics. Broadly defined, digital therapeutics is software (e.g., an app) or a device that can improve a person’s health, using clinically-validated disease management and treatment.

What will it take for doctors to prescribe apps? Three things:

  1. Regulatory approval. The FDA has already cleared at least one DTx solution (WellDoc, Inc.) and is piloting a Software Precertification (PreCert) Program to develop a firm-based (vs. a product-based) regulatory approach for digital health solutions, ultimately speeding time-to-market and reducing regulatory approval time.
  2. Reimbursement. WellDoc’s solution also has a billing code to ensure physicians and health systems will be reimbursed for prescribing it, according to Anand K. Iyer, WellDoc’s Chief Strategy Officer.
  3. Evidence of efficacy. Clinical outcomes data must be published in peer-reviewed medical journals before digital therapeutics become standard practice.

Here are some of my favorite digital therapeutic solutions from the PCH Alliance Life Sciences and MedTech Roundtable at the 2017 Connected Health Conference:

  • Akili Interactive Labs provides digital treatment for neurological disorders, including autism, depression, Alzheimer’s disease and traumatic brain injury. Akili’s Project: EVO™ ADHD is currently being evaluated in the STARS-ADHD study for potential FDA approval for ADHD.

  • Mio Global is developing next-generation wrist-based monitoring which uses 24x7 heart rate signatures and adaptive filtering technology to identify anomalies and predict cardiac conditions -- heart rhythm disorder, high blood pressure and atrial fibrillation.

  • Omada Health offers obesity-related digital therapies that reduce the risk of type 2 diabetes, heart disease and stroke. A September 2017 study published in BMJ Open Diabetes Research & Care validated three-year clinical outcomes for its digital diabetes prevention program: Omada participants maintained meaningful reductions in body weight and A1c for three years.

  • One Caring Team prescribes Virtual Reality to reconnect older adults to life. The Aloha VR™ solution reduces seniors' pain, anxiety, depression and dementia. CEO and founder Dr. Sonya Kim says that she and her team have captured 2,000 videos of seniors using virtual reality to alleviate their symptoms.

  • WellDoc's prescription-based diabetes patient coaching program, BlueStar™, uses patented clinical and behavioral algorithms, is certified by the FDA, and even has a billing code to ensure physicians and health systems are reimbursed for prescribing it.

  • Wellpepper, Inc. prototyped a voice-powered scale for diabetic foot ulcers to win the 2017 Alexa Diabetes Challenge.

I have no doubt that as clinical efficacy for digital therapeutics is demonstrated, physicians will prescribe apps and other digital therapies just as they prescribe drugs today.