On 16th June, industry representatives met at the FT Digital Health Summit in London to discuss innovation and disruption in digital health.

Digital health technologies, including healthcare apps, have the potential to offer alternative healthcare pathways and, if utilised correctly, have the power to transform healthcare. But do healthcare apps risk being defeated by a lack of patient engagement?

Improvements in Digital Health

Advances in technology, such as widely available internet and smartphones, have allowed patients greater exposure to a wealth of medical information. Indeed, one in 20 Google searches is healthcare related, with many patients researching their symptoms or disease online before going to see their doctor.

Digital health has the potential to offer better care, at a lower cost, with improved patient engagement and increased patient satisfaction. But with these benefits comes complex regulatory, political and practical challenges.

At the recent FT Digital Health Summit industry representatives met to discuss some of the major issues facing digital health technologies today, including:

  • The importance of patient engagement;
  • The need to ensure that healthcare apps are developed in a user-friendly way to provide a benefit to patients;
  • Appropriate regulation of healthcare apps; and
  • Data privacy and cybersecurity.

Patient Engagement

A key aspect in the development of a successful healthcare app is patient engagement. For example, a recurrent problem in healthcare can be that patients are not getting the right outcomes because they either forget to take their medicines or they stop taking their medicines entirely. Digital health can offer a solution by reminding patients to take their medicines. However, it is crucial to engage patients when developing such apps to ensure usability. If the app isn’t user friendly, the patient is unlikely to use it.

Another key issue in developing healthcare apps is finding the incentive to motivate a patient to take responsibility for managing their disease and/or treatment. Patients that seek to subvert the system, for example by putting their Fitbit in the tumble dryer, will provide misleading readings to their doctors and are not likely to see any improvement in their healthcare.

App developers should concentrate on finding a solution for a genuine problem, and not seek to create a solution for a problem that doesn’t exist. For example, an app that increased the text size of websites to allow patients with impaired vision to view the text was rejected on the basis that the old fashioned magnifying glass was far more user-friendly.

An example discussed at the FT Digital Summit was the development of digital technologies by MSD for Mothers, an initiative from Merck which focuses on helping make pregnancy and childbirth safe and healthy for women. Their approach to digital innovation is built around three principles – patient-centric, data driven decisions and a platform approach. For instance, MSD for Mothers recognises that in some parts of the world where illiteracy is high, their apps need to use voice recognition technologies to give women access to healthcare.

Clinical Trials

Involving patients with the development of digital health technologies can also benefit clinical trials. For example, conducting a pilot clinical trial to engage patients in how the clinical trial will be run could result in a number of patient-focused recommendations, which could lead to a better run, more efficient clinical trial.

Apps can be used to assist with:

  • patient recruitment (including when this involves genomic profiling);
  • patient participation during the conduct of the trial (e.g. by using alerts to increase patient compliance); and
  • patient engagement (e.g. asking patients how they would view an improved quality of life and looking at digital health options that could be developed to meet that need).

Involving patients in the development of the clinical trial design could lead to a more efficient and patient-outcome focussed clinical trial, and ultimately a user-friendly end product.

Regulation

The relative ease by which a non-compliant app can be produced and placed on the market in the EU is a cause for concern. It is critical that healthcare apps used to monitor vital physiological functions are appropriately regulated and tested. For example, it’s easy to see the potential dangers of an app monitoring heart rate as part of treatment for heart disease that produces widely inaccurate results.

Under the current legislation in the UK healthcare apps (i.e. those with a medical purpose) are likely to be classified as medical devices. This means the app will need to undergo a conformity assessment (which may include clinical studies) and be validly CE marked before it can be placed on the market in the EU.

The regulatory framework for medical devices is complex and often requires a significant amount of resource. For this reason, many technology companies looking to develop digital health products are choosing to partner with life sciences companies.

To further aid app developers’ understanding of the regulatory considerations in developing a healthcare app, the European Commission is seeking to discuss with stakeholders the options for policy actions (including legislation, self- or co-regulation, policy guidelines, or standards). Indeed the European Commission’s second draft of the “EU guidelines on assessment of the reliability of mobile health applications” is currently open for input and comments.

“Best practice” voluntary industry codes already exist in the pharmaceutical and medical device industries. It may be the case that industry leaders come together to collaborate in order to develop standards that should apply to healthcare app development (including the conduct of clinical studies) to ensure such apps are developed with the appropriate standards and regulations in mind.

App Accreditation

As with many things digital, there is a risk that over time so many healthcare apps emerge that the choice of healthcare apps available for any given disease may become overwhelming for patients, with each app offering something slightly different from the next. To combat this, regulators could consider introducing an app “accreditation” system, whereby particular apps are recommended over others. Indeed, the National Information Board is currently considering how to use the NHS Health Apps Library to endorse patient-focused health apps. However, while app endorsement has the potential advantage of narrowing patient choice, obtaining “accreditation” is likely to be a costly and time-consuming exercise.

Data Privacy and Cybersecurity

The privacy and security of health information collected and used through digital technologies is frequently a concern. Health information can be among the most sensitive information about an individual. Understandably there can be greater risks to data associated with mobile technologies. The challenge for industry is to:

  • Reassure patients that they have a degree of control over their data;
  • Keep the patient’s trust by ensuring their data is safe and secure;
  • Build digital health systems that are accessible, effective and resilient; and
  • Ensure that any mistakes in clinical records can be quickly corrected.