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Do you use medical or health monitors at home, or apps on a smartphone? Do you know if they are regulated by the government?

mHealth is making easier to be proactive about your own health, and to take a significant role in monitoring it. Along with the benefits of this hands-on approach, however, this trend carries risks from the limited knowledge that patients have about such devices relative to medical professionals.

In the United States, medical devices are regulated by the Food and Drug Administration (FDA). The FDA’s definition of a medical device is wordy and convoluted: “an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other” thing that meets any of three criteria:

• Intended to diagnose, cure, treat, prevent, etc. diseases or other conditions

• “Intended to affect the structure or any function of the body” but not through metabolism or chemical action (which would classify it as a drug, regulated separately)

• The FDA says so

This covers all the obvious, serious medical equipment like X-ray machines, surgical apparatus, contact lenses, and hypodermic needles. On the less significant items, the distinction can seem more arbitrary. If a doctor examines you for strep throat, the tongue depressor she uses, a small variation on what is likely the oldest tool used by humans, is a regulated medical device. A pedometer on your smartphone? Not regulated.

Mobile medical apps themselves can be regulated; the FDA released guidelines in 2011 for such apps. An app qualifies as a medical device if it serves as an accessory to a device that is already regulated or if it transforms the mobile device into a medical device by causing it to meet the original criteria.

Of particular interest for mobile devices are physiological monitors and the sensors that they use, like pedometers, glucometers, and heart rate monitors. The question of regulation such was addressed in a meeting between Apple and the FDA, notes on which were recently released through a Freedom of Information Act request.

In the FDA’s notes, they stress that the intended purpose of the device is critical. If it relates to a particular disease or condition, nearly anything can be a medical device; if not, regulation is unlikely. If a blood glucometer, which measures blood sugar, is intended to be used by diabetics to monitor their condition, it is regulated. However, the FDA pointed to glucometers as an example of sensors that could be unregulated if designed and marketed for a non-medical purpose like nutrition.

This guidance opens the door for a host of non-regulated quasi-medical sensors. Much of mHealth technology is explicitly designed for general health and wellness, though some companies are tackling legitimate medical treatment.

Essentially this means that users should assume a personal health sensor or app is unregulated unless the manufacturer states otherwise. Caution when using unregulated health products is wise; regulation ensures accuracy and privacy, and unregulated products may offer neither.

Emergency care is a big problem in the American healthcare system, and one that mHealth and telehealth have the potential to ameliorate.

While a hospital emergency room certainly is the ideal destination for many patients in legitimate emergencies, it is also used by many who do not fit that description. Emergency departments are overcrowded, using precious resources and driving up long wait times for all but the most critical patients; partially as a result, the financial cost of a visit is exorbitant.

The astronomical (and rising) costs of emergency rooms in the US have been well documented in recent years, if not productively addressed (for an in-depth look at emergency room billing and hospital costs generally, check out this New York Times article). The article discusses a bill for $3355.96 for a few stitches, which is not as unusual as one might expect. ER prices, and hospital prices generally, are set much higher than most payers actually pay; Medicare, Medicaid, and insurance companies have negotiated lower rates, a small percentage of patients are treated though they will be unable to pay anything, and hospitals will often reduce the bill for private payers if asked. However, the sticker price is demanded of some patients.

The CEO of California Pacific Medical Center, the greatest revenue-generating non-profit hospital in the state, defends the prices as necessary to support the high costs of running a fully-prepared ER. He gave the NYT the example that the hospital’s ER needs to have a neurosurgeon on call at all times for potential stroke patients.

This could offer a more reasonable, albeit hardly more satisfying, explanation of thousand-dollar stitches: patients aren’t paying for the service they need, they’re paying for the service the hospital is ready to provide, with high fixed costs that must be covered regardless of what they do for the patient. As a Bloomberg article explains it, non-critical emergency room patients are displacing those who really need to be there, and the hospital is recouping its opportunity cost for not treating those potential expensive patients. “It’s not as though the actual value of a single stitch is $500. Rather, that price reflects the opportunity cost to the hospital of treating you rather than someone with graver (and more expensive) medical needs… [which] could very well be thousands of dollars, even for just an hour of medical attention.”

Bloomberg cites research findings that somewhere between 13.7% and 27.1% of visits to the ER are unnecessary (could have been treated elsewhere). Walk-in clinics and urgent-care centers exist for just this purpose. But frequently, the patient (or parent) lacks the resources to know if they (or their child) need the emergency room, another type of urgent care, a visit to a regular doctor sometime in the coming days, or just a bowl of ice cream.

This massive hole in the system can be filled quite effectively with telehealth. Many insurance companies actually offer a nurse hotline for their customers (or anyone who has the number) for just this kind of thing, but it can be difficult for the nurse to diagnose an unknown patient over the phone with no visuals, and even more difficult for a concerned patient to trust the unknown voice on the other end of the line when health is at stake.

Instead, modern mHealth could allow patients to contact someone in their own doctor’s office through a video-call, explain the scenario, and get an opinion on the best treatment option and where to get it. This way, the resources of the emergency room can be saved for those who really need them, while patients with lesser concerns can receive effective, safe and timely care at a reasonable price.

When Apple HealthKit was announced, we noted the high hopes experts in the industry expressed for the platform to begin the process of moving towards a universal electronic health record (EHR).

That notion was supported by Apple’s partnership with Epic Systems, the single largest EHR software vendor in the US. Epic recently made a move to further the universal EHR goal by linking their MyChart app to Apple Health. MyChart provides patients access to their medical records, including lab results and immunization records. It also allows patients to manage bills appointments.

And now, patients will be able to feed data directly into their own medical records, accessible by their doctors, through Apple Health. Health trackers recording data such steps taken or medical monitors checking blood pressure and other health stats can now sync with MyChart in this way. For patients to be able to set up the app to input their data automatically, the provider using Epic must enable the Track My Health feature, according to iMedicalApps.

As more apps and devices are tied into HealthKit, the breadth of information available through Health will grow. Eventually, it will likely cover all types of commonly used health-related data.

It is also likely, in the future, to allow users to receive and input their own data from third-party medical facilities. For example, some hospitals currently give patients a CD or DVD containing their magnetic resonance imaging (MRI) data. The patient is then expected to bring that disc to their doctor. With the ability to accept third-party data already built in for Health, it would be a small step for MyChart to add a feature to take in this type of data through the patient’s mobile device as well.  

Though Epic is just one of the many EHR vendors, it is the largest by a significant margin. As of March, 20% those attesting to EHR Meaningful Use were on Epic software (Allscripts, the runner-up, had only 10.7% market share). But their share of the population is even more impressive; as of September of 2013, Epic announced that their software was being used for health records for 51% of Americans.

That means that 51% of Americans could potentially soon be able to contribute to their own medical records through a mobile device.