FDA Adjusts to Tech Boom With Mobile Health Apps

HIPAA vs HITECH
HIPAA vs HITECH: What You Need to Know
June 11, 2018
hernia mesh
PA judge denies appeal on pelvic mesh medical liability award
June 26, 2018
Show all
Mobile Health Apps

Consumers eat up mobile health apps as FDA adjusts to technology.

Admit it. You can’t live without your phone.

You use it for everything. You have your calendar, your online checkbook, your Rolodex in your contact list, your music on your playlists. We use our phones to navigate the streets, to shop, to get the latest news – even to find love.

And to lose weight. Or measure our blood sugar.

Today, we are increasingly using our smartphones – and social networks, internet Mobile Health Appsapps and wireless medical devices — to monitor our health and wellbeing and to connect us to more information about our bodies and minds.

As the world continues to get more digitized, this trend will only grow, especially as millennials become the dominant health care consumers, both for themselves and for their families. Having grown up with the immediate gratification of technology, they are increasingly frustrated with the static nature of traditional healthcare options.

Healthcare providers know consumers are hungry for not just mobile health apps (known as mHealth) but also for wearable devices, telehealth and telemedicine. From shoes and bracelets that count our steps to a smart patch that tracks our kid’s fever, we like feeling like we’re in control of our own healthcare — with or without a doctor’s help.

Think about Fitbit, quite possibly the most recognized fitness smartwatch in the U.S. In March, the San Francisco-based company unveiled its second tracker, Versa. By June 8, they had shipped more than one million of them to retail stores.

There are already more than 318,000 health apps – fitness apps, nutrition apps, medical apps and mental health apps – around the world, nearly twice as many as there were in 2015. The IQVIA Institute for Human Data Science states that there are 200 apps being added each day and that healthcare providers who do not keep up with the mobile and technology needs of their patients run the risk of losing them as customers.

So, the digital health phenomenon is exploding and, as the healthcare industry gets more mobile, opportunities for health and wellness apps are boundless. According to a study last year, there are three fields in particular that have the best market potential for digital health solutions: Diabetes, obesity and depression. 

The Food and Drug Administration is trying to catch up with technology, but by the time test results are in and guidelines and regulations are put in place, some of these latest wellness devices and apps are obsolete. That’s why the FDA has begun a trial of a new Digital Health Software Precertification Program, a modern and streamlined approach that moves software functions and apps through the pipeline more quickly. It’s like a fast track for pre-qualified companies that already have a satisfactory record.

This allows the agency’s digital health staff to focus its oversight Mobile Health Appson mHealth apps and functions that “present a higher risk to patients” and not on lower-risk apps. Some medical industry observers have complained that this simply creates more confusion, especially for consumers who don’t know what is safe or accurate and what is, well, not so much.

And that may lead to some medical malpractice or class action lawsuits.

Take the 23andMe debacle. The at-home genetic testing service was recalled in 2015 after the FDA, which originally decided it didn’t need direct oversight, later raised questions about the accuracy of some results. The company has since removed some screenings and is back on the market, but not before a class action settlement from thousands of customers who felt defrauded.

Last year, three mHealth app developers settled with the New York State Attorney General’s Office, which had investigated misleading claims. Two of the apps (Cardiio and Runtastic) claimed to measure the heart rate but offered no proof, and a third, called My Baby’s Beat, promised to turn a smartphone into a fetal heart monitor. The companies paid just $30,000 in penalties, but the legal move shows that states will step up when the feds fail to protect consumers.

Here, at Smart Legal Solutions, we are not just prepared for the next wave of litigation stemming from mHealth devices, we are already well versed in the technology and include health app data when we collect medical records for our clients. Most other firms are not even aware that this data exists, but the team at Smart Legal Solutions knows how to find it.

So, remember us – and surging technology – next time you need medical records.

 

Leave a Reply

Your email address will not be published. Required fields are marked *