How do we regulate health apps?


APA Innovation Advisor Barry Nguyen attended the National Mobile Health Applications Collaborative Workshop Program in February to find out more about health apps.

The workshop, organised by the Australian Digital Health Agency, brought together experts and key groups at the Brisbane Convention and Exhibition Centre. The purpose of the workshop is to address the challenges of health apps and discuss how to ensure they are evaluated to benefit patients. Key groups included the Therapeutic Goods Administration, the Australian Commission on Safety and Quality in Health Care, Consumer Health Forum, CSIRO and Queensland Health.

The key questions that were considered for the workshop were:

  • do we need a national mHealth framework to manage the proliferation of mobile health apps?
  • can privacy be balanced with innovation?
  • how can safety and quality be assured?
  • do clinicians have the competence to assess mHealth solutions?

Privacy and security of the data was the primary challenge associated with mHealth apps given it is a complex area to manage and resolve with all stakeholders. There was a key discussion about the consumer perspective and it was noted that based on a small survey of consumers, they view that GPs are the most trusted source when it comes to health app recommendations. However, this poses the question of whether GPs are sufficiently trained to evaluate and recommend health apps.

Consumers also want to know who funds mental health apps as well as who endorses it. This feedback will likely apply to other clinical specialities such as physiotherapy modalities.

Other particular challenges associated with mHealth include:

  • security of connected medical devices
  • distributed and backyard manufacturers
  • empowered/participating patients/consumers
  • current regulated framework for software is outdated
  • if mHealth are not interconnected with the ecosystem, they will likely have questionable value.

There needs to be transparency and informed consent regarding the secondary use of the data and how it is managed, including the risks. In terms of providing an opinion or endorsement for an app, there were questions asked:

  • what happens after it has been updated? What will be the roles of the colleges, peak bodies and government?
  • what is the liability and duty of care of clinicians if continuous monitoring is involved?
  • should the discussion even be around apps, as digital health includes other emerging technologies including hardware, 3D printing, AI, VR and AR?
  • can an explosion of data from apps have a detrimental impact on the clinician’s workflow, leading to potential information overload and alert fatigue?

In conclusion, there appeared to be a group consensus that a national framework for health apps needs to be developed and the Australian Digital Health Agency needs to lead the charge with collaborators.

So what does this mean for physiotherapists?

The clinical application of mHealth is an increasingly relevant area given the amount of physiotherapy-related apps that are in the market and its easy accessibility to our patients. As clinicians, it is important to be informed and be aware of the benefits versus the risks of such solutions, including what would happen to your patient data, privacy and security concerns, as well as the emerging research associated with particular solutions. At this stage, your first priority should be to ensure that what you may recommend, or are aware of what your patients are using, is safe and has a potential value to their health.

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