Health mobile apps raise concerns about safety, privacy, health costs
Source: Flickr, ilamont.com
If predictions that the U.S. mobile health (mHealth) market will continue to grow exponentially in the next few years hold true, consumers will more often be able to fill in for their doctors in certain scenarios, according to a recent report by Transparency Market Research.
The more popular health apps generally are ones that consumers can use to track weight, diet and exercise, such as Map MyRun or Calorie Counter. In more recent years, however, app developers have become increasingly interested in creating tools that people can use to track blood pressure, sleep patterns, chronic pain and serious medical conditions.
No question that the ability of patients to track and store key medical information on their smartphones can bring more convenience and health benefits to their lives. However, the medical app market, though gaining popularity, is still relatively new, and consumers and patients, along with health care professionals, app manufacturers and policy makers, have raised questions about how safe and accurate these apps are, what health risks they may pose and if and how they will be regulated.
Patients can expect more safety and innovation
A lack of standardized regulations or oversight has thus far made it difficult to determine whether mobile medical apps function accurately, which can raise issues about patient safety.
Of particular concern is the safety and accuracy of “mobile medical apps,” which the U.S. Food and Drug Administration (FDA) defined in its preliminary 2011 draft guidance as apps that are either used as an accessory to, or transform a mobile platform into, a regulated medical device – essentially, any app that serves the same purpose as a traditional medical device.
Examples of mobile medical apps include those that serve as blood glucose meters, blood pressure monitors or X-Ray machines. Some existing mobile medical apps also allow doctors to turn smartphones into a stethoscope, ECG heart monitor, blood pressure cuff and a glucose meter.
These mobile medical apps are considered high-risk, as they can greatly affect a medical patient’s care and treatment when the apps don’t work as intended.
App manufacturers are going to need to have specific guidelines by which they can abide and be held accountable for the safety of their medical devices, according to federal government agencies. The FDA has set its deadline for publishing its final guidance on mobile medical application (app) regulation for the end of the 2013 fiscal year (September 30), according to FDA’s Christy Foreman, who serves as the Director of the Office of Device Evaluation at the Center for Devices and Radiological Health.
One of the FDA’s biggest challenges is figuring out how to balance patient safety with technological innovation, according to Bakul Patel, who is an FDA policy advisor and the primary author of the FDA’s 2011 draft guidance. The FDA says it hopes that setting clear definitions and regulations could have a domino effect in allowing app manufacturers to demonstrate more innovations that are beneficial to patients. In turn, patients may benefit from increased safety.
Without regulations, mobile app companies find it hard to plan
Mobile medical app manufacturers and developers, along with medical device companies and telecom and carrier giants such as AT&T and Verizon, want the FDA to publish its guidelines on medical apps as soon as reasonably possible. The longer the FDA delays, the harder it is for apps developers and manufacturers to plan.
Until they have regulations to guide them, developers don’t know whether to pursue certification of their products as medical devices, sidestep the process and jump into product development or just wait to see what the FDA has to say.
Consumers should remain wary of privacy issues
With the prospect of increased government regulation of medical apps, some consumers say they’re worried about its implications for health information exchanges and data breaches. The more personal medical records that are stored on mobile devices, the more consequential it becomes if the device is lost or stolen.
Although the FDA says it plans on regulating the manufacturing process, it said it has no plans to restrict what app developers can do with users’ data. It is possible that unauthorized individuals might gain access to another’s personal health data stored in an app if a medical app user loses or has its device stolen. App developers might also be authorized to share user data with third parties.
“Privacy policies seem to be written primarily to protect the company developing an app, not the users,” researchers said. “The only way for a user to know how great a privacy risk an app may be posing is by doing a technical evaluation – something beyond the ability of almost all users.”
It is a common misconception that Health Insurance Portability and Accountability Act (HIPAA), guarantees privacy for individual medical information. On the contrary, HIPAA provides some limited privacy protections but only applies to health care providers, health plans and health care clearinghouses that transmit payment information electronically. But there is no universal privacy rule, even for sensitive medical information.
App developers do have some incentives to protect patient privacy, which includes legal liability and potentially wasted resources. Developers who ignore privacy and security may risk incurring legal liability in the event of exposure of users’ personal information. Additionally, it is difficult for developers to remove data from a database once it has been collected. If a consumer’s app allows third parties to collect personal data, and that information becomes public, it will cost the developers more time and money to remedy the situation than it would have to make the app secure at the outset. App developers can also be motivated to protect patient privacy in order to avoid bad reviews, which can directly affect sales.
Mobile medical app users might benefit from increased accuracy and health safety as the mHealth market continues to grow and regulations become more defined, but safety regarding data breaches must be something each individual takes into consideration when using mobile medical apps.
Consumers might see change in taxes under new health care laws
Increased regulation of mobile platforms and mobile medical apps could result in their being taxed under Obamacare, according to leaders on the House Energy and Commerce Committee.
In a letter to the FDA earlier this year, the committee expressed the following concerns regarding taxes under the Patient Protection and Affordable Care Act (PPACA):
“The PPACA as amended imposes an excise tax on medical devices that was intended to generate revenue to pay for the law. If FDA determines that certain smartphone, tablet or mobile medical apps are devices for the purposes of the Federal Food, Drug and Cosmetic Act (FDCA), it raises the possibility that they would also be subject to new taxes under the PPACA.”
The Obama Administration has gone on record with a pledge not to subject consumers’ medical devices, including smartphones and tablets, to the medical device tax. However, it is possible that certain mobile medical applications –such as those regulated by the FDA-- could be taxed under Obamacare.
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