InfoLAW: Mobile Healthcare Apps

Potential Uses and Benefits of Mobile Healthcare Apps

Mobile healthcare applications (or apps), sometimes referred to as mobile health or mHealth, are a growing domain of healthcare provision that is enabled by the widespread use of mobile devices. Many companies, organizations, and educational institutions have designed apps that offer diagnostic tools, databases, sources of clinical evidence, and best practice guidelines designed for use on a variety of mobile devices in healthcare settings.

Presently, medical mobile apps are subject to Health Canada regulations if they meet the legal definition of a medical device, which is any technology intended for the diagnosis, cure, mitigation, treatment, or prevention of disease.¹ The burden of navigating the regulatory landscape around mobile apps falls on the app developers themselves, but there remain legal considerations that nurses as end users may want to consider while using mobile healthcare apps in the provision of care.

Risks of Mobile Health-care Apps

Reliability

Mobile healthcare apps, such as those created by reputable organizations that simply offer links to databases or best practice guidelines, would be expected to carry minimal risk if the information is current. However, others can pose the same risks of failure as medical devices, including faulty design, poor manufacturing quality and user error.

App software may be written by a developer without health-care training. There is also no requirement for an app to be reviewed by a healthcare provider or any healthcare organization.² One study found that there is often a lack of consistency in healthcare app development as well, since some apps are developed by startups with limited resources, while others are developed by pharmaceutical or medical device companies.³ Additionally, apps are often developed and adopted for use more quickly than they can be assessed by regulators or patched by developers.⁴ Further, apps available to you may be developed outside of Canada, which may impact their reliability, regulatory adherence, or security in Canadian healthcare settings.

Improper Use of Apps

Mobile healthcare apps should not be used as a substitute for clinical judgment. As with any other tool, the health care professional remains responsible for any clinical decisions. While apps may be used to support or assist with clinical decisions, the nurse will ultimately be expected to use their professional knowledge, skills and judgement. Also, nurses may consider whether the use of the mobile device is distracting them from providing appropriate and professional clinical care.

Even reliable apps can pose significant risks to patients if they are incorrectly or improperly used. Nurses may want to consider whether they are using health apps that have been reviewed and approved by their employers. In addition, nurses might reflect upon whether they have sufficient training to use the app accurately and appropriately.

Breach of Privacy

A significant concern related to the use of mobile health care apps is the potential for a privacy breach. Some apps can function as an electronic health record system, and with increased mobility comes an increased risk that a patient’s personal health information (PHI) could be inadvertently disclosed. It is important to know where data and patient information may be stored by the app, how the data is captured (if the app is used for monitoring), who has access to the data, and who owns the data in order to avoid inappropriate disclosure of personal health information.⁵ It would be prudent for nurses to review the privacy settings on both their mobile devices and the app and be aware that default settings may allow sharing of information with others. Nurses using apps that store PHI on the mobile device itself will need to consider which steps will need to be taken to protect and secure the information.⁶

Current Best Practices for Mobile Health-care Apps

When using mobile healthcare apps, nurses may wish to:

• Use mobile health-care apps that are reviewed, approved, and supported by your employer.
• Consider the source and any other information available about the app’s reliability before downloading it.
• Consider whether you have sufficient training and knowledge to use the app accurately and appropriately in your clinical area.
• Frequently update any apps used to ensure all data is current.
• Avoid relying on the app to complete a task you could not otherwise complete on your own.
• Evaluate apps recommended to patients to ensure they are reliable and appropriate.
• Take appropriate steps to maintain the privacy of patient PHI collected while using the app.
• Review and set appropriate privacy settings on the app and your mobile device.
• Know what permissions you are giving the app and do not install it if you do not feel comfortable giving the app the access it is requesting.
• Review the app’s privacy policy to determine whether third parties have access to information obtained and, if so, whether you can opt out.

The legal and professional issues surrounding the use of mobile health-care apps are rapidly changing as developers continue to innovate and healthcare needs continue to change, and as regulators continue to address concerns with mobile health care apps.

If you have any concerns about mobile app usage, CNPS beneficiaries can contact CNPS at 1-800-267-3390 to speak with a member of CNPS legal counsel. All calls are confidential.

1. Health Canada, “Guidance Document: Software as a Medical Device (SaMD): Definition and Classification”, (5 October 2021), online: <https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information/guidance-documents/software-medical-device-guidance-document.html>.

2. Lewis, Thomas Lorchan & Jeremy C Wyatt, “mHealth and Mobile Medical Apps: A Framework to Assess Risk and Promote Safer Use” (2014) 16:9 J Med Internet Res e210.

3. Van Velthoven, Michelle Helena et al, “Digital health app development standards: a systematic review protocol” (2018) 8:8 BMJ Open e022969.

4. Moses, Jeban Chandir et al, “Application of Smartphone Technologies in Disease Monitoring: A Systematic Review” (2021) 9:7 Healthcare 889.

5. De Jong, Andrea, Lorie Donelle & Michael Kerr, “Nurses’ Use of Personal Smartphone Technology in the Workplace: Scoping Review” (2020) 8:11 JMIR Mhealth Uhealth e18774.

6. For more information on mobile device privacy, please see CNPS’s “InfoLAW: Mobile Devices in the Workplace”

November 2013. Revised October 2024

THIS PUBLICATION IS FOR INFORMATION PURPOSES ONLY. NOTHING IN THIS PUBLICATION SHOULD BE CONSTRUED AS LEGAL ADVICE FROM ANY LAWYER, CONTRIBUTOR OR THE CNPS. READERS SHOULD CONSULT LEGAL COUNSEL FOR SPECIFIC ADVICE.