Introducing new approaches and technologies is often difficult. mHealth challenges include:
Building trust – Even though mHealth apps can improve the healthcare system and the patient experience, there’s a lack of patient trust. Patients are mostly worried about the security of their medical information and the quality of healthcare services. These concerns result in a lack of trust. So filling the trust gap is crucial for the adoption of mHealth apps.
Privacy and security – While digital transformation brings lots of benefits to various industries, it also makes them vulnerable to cyberattacks. To avoid breaches of medical and personal data, healthcare solutions need to focus more on tools and technologies that provide data security.
Compliance with healthcare legislation – Different countries have regulations that protect personal health information. A mHealth app, just like any app handling sensitive data, must comply with laws of the countries where your app users live. In the US, for example, mHealth apps must comply with the Health Insurance Portability and Accountability Act (HIPAA). This act regulates how personal health information is collected, stored, and shared. That means that mHealth apps targeting the American market must be developed based on HIPAA rules.
Lack of regulation – Before a drug is allowed to go to market, the Food and Drug Administration (FDA) has to approve its safety. Without their approval, the drug cannot legally be sold. The FDA explained that they are “responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices.”
According to research2guidance, as of 2017, there were approximately 325,000 mHealth apps available. Though users have hailed many of these benefits, the FDA has so far only approved a fraction of them. mHealth apps are perhaps not at the top of the FDA’s priority list; they are considered by experts to be “low-risk,” meaning that the use of them is noninvasive and unlikely to cause considerable physical harm. For this reason, the FDA does not believe that they require regulation in the same way that drugs and other therapies do.
Although this means that app development companies can roll them out to the paying public faster, it does also mean that there is little testing in patient communities to catch any issues the app may have, which could cause harm to the user further down the line. Interestingly, there have been hints that instead of the FDA working to approve apps themselves, entire app development companies could gain their approval.
Despite the fact that, as discussed above, the majority of mHealth apps have neither been tested in the patient community nor approved by regulatory bodies such as the FDA, many patients do rely on them in their everyday lives. Many users of mHealth apps are choosing to use them instead of seeking professional help. This is problematic for several reasons, the most important being the fact that the vast majority of these apps are not regulated.
In fact, in 2015, researchers at Harvard Medical School in Boston, MA, conducted a study into symptom-checking websites and apps. The researchers discovered that, of the top 23 symptom checkers, “correct diagnoses were listed first in only 34 percent of standardized patient evaluations.” The analysis also revealed that the correct diagnoses were listed by the symptom-checking tools within the “top 20 possible diagnoses” in less than 60 percent of the evaluations. This has dangerous implications — especially the fact that receiving an incorrect diagnosis or not getting one at all could hinder proper treatment and possibly endanger life xiii.