There has never been a better time to explore digital health in North America. Legislative, societal, and financial changes are all taking place in favor of mHealth advancement and innovation. There has never been less red tape, more enthusiastic consumers, and more available funding for entrepreneurs and leaders in the healthcare space interested in disrupting healthcare.
Let’s start off with legislative: how is it changing, and what’s so different about it?
Legislative: FDA Guidance of Mobile Health Apps
The FDA recently issued final guidance on mobile medical apps. The definition of a mobile medical app now covers two types:
- Accessory to a regulated medical device
- Transforms a mobile platform into a medical related device
What this means is a device that interprets health information (e.g., stores x-rays used to make a diagnosis) or replaces a traditional device (e.g., acts as an electrocardiography machine to detect abnormal heart rhythms) would be regulated by the FDA. Dr. Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, has stated that mobile apps will be regulated according to function and risk: if a device with a similar function used in a hospital is regulated, a similar mobile app will likely be regulated as well.
While this still means regulation for vital health apps, this change also means the bulk of mHealth and mobile fitness startups no longer have to navigate the red tape of FDA regulations. For example, wearable technology such as the Jawbone Up will not be regulated by the FDA. As such, mobile fitness options will be able to evolve faster than before.
Societal: Patient Information and Acceptance of Mobile Apps
Increasingly, the medical profession is moving away from storing patient’s medical information in beige folders locked away in doctors’ offices. As people are finding more sources of fitness and health measurements outside of the doctor, they also naturally become responsible for keeping these types of health information themselves. Patients are embracing this change: according to this PMLive study, an overwhelming 90% of respondents would take the offer of a mobile app to help track their illness, whereas only 66% would accept a medicine prescription from their doctor.
Healthcare providers face increasing costs; at the rate baby boomers’ healthcare costs are increasing, the system could go bankrupt if providers don’t reduce their budget or shift responsibilities to other stakeholders. Doctors and health practitioners are releasing information to patients in order to free up administrative resources. Patients are responsible for their own information; the benefit is that they can take it to the various doctors they’d like an opinion from, instead of waiting for information to get transferred between offices and different health care providers.
Financial: Increasing Investments in Health Care
Rock Health shared some remarkable discoveries about investments in mobile health: for example, digital health funding was up 12% in the first half of 2013, totalling $849m in this period.
According to Forbes, General Electric has set aside a whopping $2Bn for health care solutions in the next five years. Investment funds such as The Social+Capital Partnership have hundreds of millions of dollars for startups and entrepreneurs. They are also narrowing their focus to fund health and fitness apps. These two changes make significant amounts of funding available for potential entrepreneurs.
With these transitions taking place, organizations – even individuals – with great ideas for digitizing health have never been in a better position to take advantage of the opportunities and funding available. Over the next few years, I expect to see mHealth really take off, bringing patients more choice on a global scale.
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