We use health and medical apps every day to track monitor our health, track fitness or even help diagnose health problems.
A new study estimates that one and a half billion smartphone users have a health app installed. But the medical app we’re using might be doing us more harm than good. Recent research by the IMS Institute for Healthcare Informatics found that fewer than 25 percent of medical apps offered patients legitimate medical information. Experts are concerned that many health and medical apps could give patients incorrect or insufficient information, risk the privacy of their health data, or even sell it. In some cases, apps that advertise diagnostic features have been revealed as fraudulent.
Lack of health app regulation
Even when they’re not deliberately malicious, many health apps don’t have any quality checks or regulation. For example, a recent study into hypertension apps found that many make medical claims without clinical validation or FDA approval. The research by the Journal of the American Society of Hypertension found that fourteen percent of the top 107 hypertension apps in the Google Android store made medical device claims. The apps’ features included using smartphone’s camera to measure blood pressure. The app claimed that this is an accurate measurement.
In fact, there is no evidence that measuring blood pressure with a camera is effective. Patients relying on one of these apps to manage hypertension could be getting incorrect information, and becoming sick as a consequence.
The authors conclude that much more research is needed before we can rely on apps to monitor our health reliably: “High quality, adequately powered randomized controlled trials are needed to evaluate the effectiveness of mobile-health interventions on clinical outcomes in hypertension.”
So what legal recourse does a patient have if something goes wrong after relying on a medical app?
A representative from the medical law firm Patient Claim Line recently stated that ‘health app developers are unlikely to face medical negligence suits for a misdiagnosis, since there’s no doctor-patient relationship between the app developer, the provider and the patient. That’s one of the reasons patients should always communicate with the doctor if they are using a health app, and check the accuracy of the information it provides’. But she supported the use of health apps, adding that their point ‘is to make the patient much better informed and to ask the doctor much better questions, so together they can do a much better job avoiding medical errors’.
Although app developers are unlikely to face a medical negligence suit, developers could face their own types of liability. In addition to potential liability for violating the FDA’s medical device regulations, private apps are likely to be subject to product liability claims, for example through a design defect, a breach of warranty or failure to warn.
Medical health apps help us by monitoring and analyzing our health data, but in the process they collect a huge amount of personal data. That wonderful mine of information can be a danger zone if it’s not properly secured and protected. Privacy and security of patient information are becoming major concerns.
Executive Director of The App Association Morgan Reed advises consumers to stay on the alert: “if you’ve been given a free application and you can’t figure out how it is being paid for, then the chances are high that it is being paid for by using your information for advertising.’
Even if the app isn’t selling your data, merely having insecure storage or data transfer could put your privacy at risk.
Addressing the risks
Rising awareness of the problem is leading to solutions. Several app accreditation programmes have been launched to address concerns about the quality and safety of health apps. One example is the UK’s National Health System (NHS) Health Apps Library; a curated list of apps for patient and public use. Under this programme, registered apps undergo an appraisal process that examines clinical safety and compliance with data protection law.
The app industry, government and the public realize it is important for mobile health apps to be reviewed, approved and properly regulated by governments and their health authorities.
As mobile technology becomes more embedded into our healthcare, there are opportunities for action to further address these privacy and safety concerns, minimize the risk of future privacy breaches and to prevent misdiagnosis errors and security flaws.