Mobile apps offer many potential benefits to doctors and patients:
- Mobile apps can help patients self-monitor their conditions and can alert them and their physicians to problems before they become serious medical issues.
- Some of these apps are regulated by the FDA. For example, patients can monitor their heart rhythms with an FDA-approved device that wraps around their iPhone.
- Mobile apps can be a tool for patient education:
- A better-informed patient is more likely to understand risks and, if there is an adverse event, may be less likely to file a lawsuit.
- Mobile apps help patients remember important information about their healthcare. Patient pamphlets and other educational materials are often lost or forgotten. Patients forget 80 percent of the information they are told and inaccurately remember an additional 10 percent, leaving patients with just 10 percent of the information remembered correctly.
- Mobile apps can engage patients in their healthcare:
- Many patients today are interested in becoming as involved in their care as possible.
- One patient engagement platform that connects patients and physicians, Healthloop, markets its product as a way to have very satisfied patients who will publicly share their experience. This platform monitors compliance and adherence to the treatment plan; checks in with patients, thus eliminating phone calls; collects outcome data; educates and reinforces education; and identifies at-risk patients quickly to reduce readmissions.
But not all of the apps currently on the market are approved or regulated by the FDA, and the use of mobile apps does not come without liability risks. The Doctors Company has not yet seen malpractice suits that involve mobile apps because the use of these apps to monitor patients is fairly new. Malpractice lawsuits may not be filed for several years after the adverse event, so with the increased use of mobile apps for healthcare, we expect there will be lawsuits involving mobile apps in the future.
Physicians could face allegations of failing to educate the patient/family about the risks and limitations of the app or failing to act appropriately if the app goes offline or malfunctions. Product liability, negligence, contract law, and even malpractice tort law could be applied to possible causes of action in lawsuits brought because of an injury connected to use of a mobile app. Injuries could occur if:
- The physician receives information from a mobile app and does not act on this information. Physicians have a legal duty to review real-time data direct from the patient and respond. Mobile apps raise patient’s expectations of how a physician will act—the patient/family expect that the patient is monitored 24/7 and the physician will respond “within a moment’s notice.” When an adverse event occurs, if a patient believes the physician failed to act on information from a mobile device, the patient might sue. If physicians don’t respond to information from an app, this will be recorded in the metadata, which can be used in court.
- The readings received from a mobile device are wrong and treatment is prescribed based on the wrong data. There are a lot of untested apps on the market that may be unreliable or even dangerous. Apps are also vulnerable to being hacked, resulting not only in potential loss of personal health information (PHI) but also in potential malfunctioning of the app.
- Patients rely on technology alone, leading to decreased phone contact with the physician when symptoms arise or there are changes in the condition that require immediate action.
These apps can be useful tools to support a comprehensive care plan, but physicians need to be knowledgeable about these apps so they can educate their patients about the apps’ limitations and potential risks.
Consider limiting your patients to one mobile app that you agree to monitor. This will make it easier to control the incoming data and help make the best use of the app. Other important considerations include:
- Consider whether the two-way communication between you and your patient is secure and, therefore, HIPAA/HITECH compliant. Ask the vendor for assurance that the app is HIPAA-compliant and that data is encrypted for security.
- Know the app:
- Vendor information, such as updates, downtime, and critical value alerts.
- How will it interface with your EHR?
- Is the device regulated by the FDA as a medical device?
- Will you get alerts by e-mail or a phone call from the vendor when the app isn’t working?
- Beware of the possibility of lack of security when using public Wi-Fi with the app.
- Clearly communicate and educate the patient/family about the purpose of the app and how and when the data is transmitted to the clinician.
- Avoid assuring the patient that the app will “take care of everything.” Educate the patient/family about the limitations of app, with specific examples of instructions for the patient to follow. For example, can the algorithm be changed for specific patient needs?
- Identify a contact person within your organization to troubleshoot and be available to address technical problems.
- Have the patient/family sign a consent form that describes the risks, benefits, and purpose of the app.
- Do not do this alone! Avoid utilizing medical apps without support from your organization.