With mHealth apps and wearables slowly gaining favor in healthcare provider circles, it's important to remember that these solutions not only have to appeal to doctors and their patients, but pass legal muster as well.
Writing in Inside Counsel Magazine, Krysti Wolff, a special counsel with the Washington, D.C. office of Kelley Drye, offers six guidelines for developers and healthcare providers looking to market a new app or device:
[See also: 6 tips for vetting mobile apps]
1. Know the landscape. "Regulators are just as interested in the wearable and mHealth app market as consumers," she writes. And there are several agencies involved with different aspects of the industry, including the Federal Trade Commission, the Food and Drug Administration, the Consumer Product Safety Commission and the Federal Communications Commission. Knowing who oversees what could mean the difference between a product going to market on time and one being held up and possibly subject to legal action.
2. Prove what you claim. "Statements about what the product can do must be supported through evidence," Wolff says. "The level and degree of evidence will vary depending on the claim but testimonial evidence in never sufficient as claim substantiation." That's an important point to consider in a landscape where health and wellness uses are slowly venturing into clinical territory, and any product that pledges to affect clinical outcomes is sure to come under the microscope.
3. Intended use matters. How a developer describes an app or device – for example, saying a wearable tracks one's heart rate, as opposed to detecting an irregular heart rate – could mean the difference between an FDA classification as a medical device and one that wouldn't need so much scrutiny. Wolff emphasizes that developers need to be very careful in explaining what a product can do well before it's put on the market, so that it can be properly classified.
4. Design privacy and security into the product. This is crucial when dealing with sensitive health data. A wearable device might last only a short while, Wolff notes, but the data is collects survives much longer. "Incorporate privacy and security into the product design to give consumers choice as to information collection, use and deletion," she says, "and protect that information with robust security measures." In addition, she says, prepare for a hack or data breach and map out what should be done in the event that happens.
5. Pay attention to HIPAA. Too many people make the wrong assumptions about the HIPAA, Wolff says, thinking it applies to all health information. While "the vast majority" of apps and wearables don't fall under the HIPAA microscope because they don't share protected health information with a provider, she says developers should take the time to analyze the platform being used (Google, Apple or Android), the information being gathered and how it would be shared.
6. Make the legal team a part of the planning process. "Few things erode trust faster than a publicly disclosed legal misstep that could have been prevented," Wolff warns. "The old adage applies both to health wearables and to obtaining solid legal counsel: An ounce of prevention is worth a pound of cure."