Mobile medicine apps are the future, as we move increasingly into digital, virtual communication; yet FDA medical device and other legal issues remain.
Recently it was reported that everything in medicine in going mobile:
Cardiologist Eric J. Topol, MD, was on a cross-country flight when an attendant made an announcement asking if there was a doctor on board.
Dr. Topol, chief academic officer for Scripps Health, responded and was brought to a man who was in obvious trouble. Only a year or two ago, Dr. Topol would have had to make an educated guess and hope he could take care of the patient until the plane landed.
This time, though, he pulled out his iPhone, and with an app that produces an electrocardiogram, he determined that the patient was having a heart attack. The plane made an emergency landing while paramedics waited on the ground to take the patient directly to surgery to open the blocked arteries causing the attack.
Though the story is an extreme example, it illustrates why mobile technology was such a big focus of the 2012 annual meeting of the Healthcare Information and Management Systems Society, where Dr. Topol shared the story. With each passing day, mobile technology is giving physicians more opportunities to practice medicine from anywhere, at any time....
Mobile technology is bringing the patient’s bedside to the physician’s smartphone or tablet computer.....
Just a few years ago, physicians with patients in hospitals either had to be at the patient’s bedside to get a complete view of what was going on or rely on a floor nurse’s interpretation of what the patient’s monitoring devices showed.
Mobile technology has made it possible to bring the patient’s bedside to the physician’s smartphone or tablet.
Applications can send a physician real-time updates on a patient’s condition regardless of where the physician is. A doctor can monitor the wave-forms of cardiac monitors, contraction and fetal monitors, ventilators, and a host of other bedside monitors. A dashboard displays a patient’s vitals and lab values, and all the information from the patient’s electronic health record can be accessed from a device small enough to fit in a pants pocket.
If you are fan of Ray Kurzweil, who wrote The Age of Spiritual Machines and The Singularity Is Near, you'll recognize this scenario: from Web to mobile to implants in our bodies - tiny nano robots that monitor our health and give us instantaneous boosts and repair. The emphasis on mobile medical technology is a way-station to that reality.
FDA and other legal and regulatory issues, however loom.
Recently, for example, the FDA announced that when cellphones are used as medical devices, they are subject to legal rules and regulation governing medical devices. Smart phone? Smart FDA.
Telemedicine and legal rules governing corporate practice of medicine and unlicensed medical practice also may apply. For example, see:
- Corporate practice of medicine doctrine varies by state and by prohibition
- Telemedicine, Telepsychology, Telepsychiatry and Telehealth Legal Issues
- Telemedicine legal exceptions require careful scrutinty
- Telemedicine laws vary by state
- Telemedicine Legal Issues
- Online Health Services and Products (FDA and FTC Legal)
Intellectual property concerns, including copyright, trademark, and patent, also will be important.
If you are developing a mobile medical application (app) or a device for e-health, be sure to consult with an attorney familiar with Food and Drug Administration laws governing medical devices, Federal Trade Commission rules governing advertising, state medical licensing and telemedicine rules, and other areas of law and regulation.