"There is good news for the consumers of these mobile healthtech startups. The FDA recently announced a partnership with the FTC to begin regulating mobile healthcare applications. The program was created to open a channel of communication with developers about the specifics behind mobile healthtech apps. Developers answer high-level questions about how the app works, then receive information about laws and regulations of standards that the app will need to meet.
For instance, how much personal information does the app collect? Depending on the answer, the app could need to be The Health Insurance Portability and Accountability Act (HIPAA) was enacted by the U.S. Congress in 1996. Title II of HIPAA, known as the Administrative Simplification (AS) provisions, requires the establishment of national standards for electronic h... More and/or COPPA compliant. The FTC’s program can show developers how to make sure the application they are building meets those standards — giving consumers access to apps that help monitor and benefit their health in a safe and secure manner.
This regulation is critical to consumer health. Consumers don’t necessarily research or understand the science behind the latest up-and-coming healthtech fads. It’s up to the companies themselves and the regulating bodies to do that due diligence on their behalf. Transformative digital health companies have the potential to improve our health and enrich our lives, but not if they are built on false data. When people without medical degrees rely on data from companies that may not have FDA approval, there’s a risk that they could make dangerous decisions about their own health."
Read the full article at: techcrunch.com
Be sure and read the fantastic article by Mylea Charvat in TechCrunch, The growing pains of mobile health.
Mobile health technologies are pervasive and will only continue to grow in number. Healthcare with all its problems is seen as a bright, shiny opportunity for entrepreneurs and developers to swoop in and "disrupt." This will likely accelerate with the introduction of open APIs and the applicability of FHIR to mobile technologies.
However, and this article so perfectly states, healthcare is regulated for some very good reasons that the Silicon Valley mentality has a hard time grasping. The saying "move fast and break things" may work well for other industries, but in healthcare it can be life or death, literally.
It is good to see that the FDA and the FTC have teamed up not to regulate, which would likely stifle innovation, but to educate those eager to introduce solutions that just may keep us or our loved ones healthier.