About one month ago, the UK National Institute for Health and Care Excellence (NICE) finished consultation on a statement of intent outlining how they proposed to broaden the sources of data they use to develop guidance.  

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The data sources considered in the statement included the following:

  • ‘real world data’, such as electronic health records

  • audits

  • registries

  • surveys.

Vitaccess provided feedback on this. We were very pleased to see the statement of intent, and to see NICE once again at the forefront of thinking by health technology appraisal agencies. NICE’s openness reflected other significant gestures, such as the US Food and Drug Administration (FDA) under the 21st Century Cures Act.

However, we wished to have seen more discussion in the statement about data from mobile devices and patient-generated health data, and how they can form a key part of real-world evidence.

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Vitaccess’ MyRealWorld® is a platform that lets patients record their experiences of diseases and treatments at convenient times and places. We designed our app by collaborating with patients, patient advocates, and medical professionals around the world.

MyRealWorld® allows patients to take advantage of cutting-edge mobile technology to provide real-world evidence. The app thus gives patients a leading role in providing the information that helps researchers understand their disease and improve treatment. Researchers who wish to improve patients’ health outcomes need to hear about patient experiences directly from patients. We developed MyRealWorld® to make sure that happens.

We believe that NICE’s statement lacked a clearly articulated ambition for how the collection and use of patient- and caregiver-reported data from apps and mobile devices will be assessed by the organization. We believe it is critical that there is a rigorous methodological framework for such assessments. This should include scrutiny of the study methodologies behind the data, data sources, data quality, and more.

We anticipate that these details will appear in the methodological guidance to follow, but would like to see presentation of NICE’s positions on, e.g., participative study development, use of approved protocols, ethics approval and institutional review board or independent scientific executive board oversight, and participant information briefing and informed consent.


We see the ambition outlined by NICE clearly aligning with many other groups around the world, from regulators (e.g., the US FDA’s MyStudies app) to patient advocacy groups (e.g., the EURORDIS Rare 2030 project, which focuses within the context of rare diseases and needing new approaches to patient registries and data collection, and Innovative Medicines Initiative's GetReal Initiative).

These technologies represent a meaningful expansion in the ability not only to capture data otherwise unavailable, particularly in rare diseases, but to do so collaboratively with patients and caregivers. However, these data so generated must be robust, reliable, and credible. For this, methodological guidelines are needed, such as they exist with NICE across many domains of evidence and research.