Apple has the uncanny ability to make things look cool and accessible. The company announced that the iPhone 6 and Apple Watch will help set the future of mobile healthcare. Mobile health technologies—also known as mHealth—have been touted as an avenue to make people take better care of their health and manage chronic disease. But the market is over-saturated, under-regulated and littered with reliability issues. In addition, data security fears bring about a slew of legal concerns.
In 2013, there were more than 43,000 health-related applications in the iTunes App Store. More than 16,000 related to patient health and treatment. Since the FDA has only awarded premarket 510(k) clearance to roughly 100 apps or devices, it is clear that some are really missing the mark.
Let’s say you’re at risk for heart failure, and your doctor recommends an app on the Apple Watch that uses the device’s heart rate monitor to analyze your heart for irregularities and arrhythmias. The app is supposed to send regular updates to your doctor and warn of any problems; however, something goes wrong and you have a heart attack because you weren’t notified about an arrhythmia showing for the last three weeks.
What should you do? Sue the software company that made the app? Sue the doctor for medical malpractice for recommending the app? You’re likely going to have a rough time doing so. The key to establishing negligence and medical malpractice against a doctor is proving that they fell below a standard of care that any reasonable doctor would have done in similar circumstances—a concept far more complicated than it seems.
“The problem with these apps is they’re so new and novel; it’s probably going to be hard establishing a standard of care, or what a reasonable doctor would, and would not do when using these products,” says Nathan Cortez, a professor and associate dean for research at SMU Dedman School of Law, who recently published a paper about the necessities of clearer mHealth regulations.
Eventually, he says we’re going to see lawsuits concerning this. Until then, it’s up to hospitals and professional medical societies to establish standards of how doctors should use and recommend mHealth products—a conversation that should take place sooner rather than later.
Let’s say in our arrhythmia example the app or device itself is deemed the guilty party, not your doctor, then state law gives you three ways to seek legal ramifications.
The most common tort case will likely be about a “design defect” that caused your injury, Cortez says. Another option is a “breach of warranty claim”, where the developer warranted that the product would work a specific way but failed to keep its promises and that led to your injury. Lastly, he says there is a “failure to warn” claim, in which the developer didn’t warn you that the app may not work, or maybe you weren’t told about an updated version and got injured using an older version of the app.
There are two big roadblocks when trying to sue a developer or manufacturer using any of the above three claims: FDA regulations and developer/manufacturer liability agreements.
When it comes to mHealth, the FDA’s guidelines are a bit vague and leave a lot open to interpretation, says Glenn Cohen, a Harvard Law School professor, and the faculty director at Petrie-Flom Center for Health Law Policy, Biotechnology & Bioethics.
Unlike traditional medical devices, the FDA does not usually use a full-blown premarket approval procedure for mHealth. Instead, the agency uses a non-binding, lesser process called 510(k) clearance, which doesn’t necessarily say that a product is safe and effective, but that a product is substantially equivalent to a device that is already on the market, Cohen says.
In general, the FDA relies on developers to act in good faith for regulatory approval, instead of requiring the higher standards used for medical devices. While this tactic is time and cost effective, the potential for dangerous devices to slip through to consumers is still there.
A defense in court is tricky because of these ambiguous requirements. However, just because some aspects of the device are given FDA clearance doesn’t mean the devices are lawsuit proof. Anything included in the device or app that the FDA doesn’t speak to or require is still vulnerable to a state-level lawsuit.
In the end, your lawsuit may come down whether a jury feels the device fell below established standards.
However, your case may not even have enough reason to get to court due to “limited liability exclusions”.
Liability-limiting terms of service agreements that tech industry developers and manufacturers are so fond of will likely take on a whole new role when mHealth goes mainstream. Cohen and Cortez say that companies like Apple will likely make users sign some form of agreement which either places all liability on the consumer, or forces some type of mandatory arbitration to try and stay out of court.
However, this method of self-protection may not work everywhere since some states, such as Apple’s home state of California, won’t recognize medical waivers of liability and prohibit contracts that exempt one party from responsibility for negligence, because they’re contrary of good public interest.
These legalese concerns are important because tech industry isn’t accustomed to stringent regulations, and consequently developers may unintentionally put innovation ahead of safety. Considering these products are directly influencing our physical livelihood, some form of legal protection is necessary to ensure consumer protection and product confidence.
For now, it’s wise for people to actually read through whatever ridiculously complicated liability agreements companies might include in their mHealth products. Otherwise, you might be signing up for a little bit more ‘use at your own risk’ than you bargained for.
Sources:
510(k) Clearances. FDA.
http://www.fda.gov/medicaldevices/productsandmedicalprocedures/deviceapp...
Apple Health: Issues and opportunities for users and app developers. NueMD. http://www.nuemd.com/blog/apple-health-issues-opportunities-users-app-de...
Can Apple build a cool and convenient iWatch? The New York Times. http://www.nytimes.com/2014/09/08/technology/can-apple-build-a-cool-and-...
Could the Apple Watch save lives? Fox News. http://www.foxnews.com/tech/2014/09/17/could-apple-watch-save-lives/
Cortez, J. Nathan G et al.DFDA Regulation of Mobile Health Technologies. N Engl J Med 2014; 371:372-379July 24, 2014DOI: 10.1056/NEJMhle1403384. http://www.nejm.org/doi/full/10.1056/NEJMhle1403384
Developer Guidelines. Apple. https://developer.apple.com/app-store/review/guidelines/#healthkit
Device Regulations and Guidelines. FDA. http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/...
FDA needs to regulate digital snake oil. Slate Magazine.
http://www.slate.com/blogs/future_tense/2013/09/24/mhealth_fda_needs_to_...
IMS Health Identifies Opportunities for Mobile Healthcare Apps to Drive Patient Engagement, Enhance Delivery of Care. IMS. http://www.imshealth.com/portal/site/imshealth/menuitem.c76283e8bf81e98f...
Medical Devices. FDA. http://www.fda.gov/MedicalDevices/default.htm
Risk assessment and product liability. Product Liability Prevention. http://www.productliabilityprevention.com/images/2-RiskAssessmentandProd...