World COPD Day, November 16th 2016 (or the 3rd Wednesday in November, annually) was a chance to take stock of one of the global heavy-hitters in disease.
Chronic Obstructive Pulmonary Disorder (COPD) claims an estimated 3 million lives per year and is well within the top 5 causes of death annually. Nationally, COPD contributes a significant burden to primary care and hospital admissions, particularly during the winter months where seasonal infections contribute to exacerbations.
Mobile technologies which are used to support the delivery of healthcare (termed m-Health) are poised to enhance the quality of COPD care, but not before several challenges are met.
Mobile Apps for COPD
Like with most things, there is an app (smartphone application) for COPD.
The Global Initiative for Chronic Obstructive Lung Diseases has contributed to the GOLD COPD Strategy (by Doctot, €5.99, iPhone only), an app which “provides the GOLD strategy for treating Chronic Obstructive Pulmonary Disease (COPD) in a user-friendly and easily navigable format”. It includes the COPD Assessment Test and mMRC Scale which could serve as a quick reference to clinicians during assessment and diagnosis of patients.
Then there are the patient-focused COPD apps. Of interest, Volari COPD IE developed by Novartis Pharma AG (free on iPhone and Android) was launched in late 2015 with the support of COPD Support Ireland. The app enables patients to record and track their COPD, and share the information with their doctor. However, of the estimated 380,000 COPD sufferers in Ireland, downloads of the app clocked in at “50-100” (according to the Google Play Store), perhaps underlining a poor awareness, lack of advocacy, or wariness of using these technologies amongst the patient or clinician population. Abroad, HGE Health Care Solutions’ COPD Co-Pilot™ app (coupled with a 24/7 call centre) has shown value as part of an early detection and treatment system for COPD exacerbations, with a clinical trial to evaluate the approach underway (ClinicalTrials.gov identifier: NCT02944591). My COPD Manager (At Point of Care, LLC) and COPD Care (Sunovion Pharmaceuticals Inc.) both offer similar capabilities, allowing patients to track their COPD symptoms, whilst COPD Navigator (LifeMap Solutions) adds features such as real-time information on local air-quality to help avoid exacerbation triggers.
Whilst the push to develop mobile apps that help with managing COPD is a noble one, their use to track medical conditions and inform clinical practice raises significant regulatory issues, as software applications that are used to guide medical treatment are now subject to the same EU regulations as more traditional medical devices (under Medical Device Directive [93/42/EEC]).
In Ireland, a register of self-declared medical devices is curated by the Health Products Regulatory Authority (HPRA), who confirmed that: “…it is possible for the general public to check which apps have regulatory approval. If the manufacturer claims that the software has a medical purpose, the CE mark should be clearly visible on the labelling/landing page of the software/description in app store.”
Prof. Ita Richardson, Principal Investigator at the Irish Software Research Centre, Lero, offered this advice to healthcare professionals who are advocating the use of health-related apps “Healthcare professionals seem to make the assumption that, just because a software product is available, either for purchase or for free from medical companies, it has been approved. This is rarely the case. These professionals would not use an unapproved physical medical device, yet there seems to be no problem using an unapproved software medical device. It is important that current and future healthcare professionals are educated to understand this. It is equally important that software companies do not release software unless it has been approved”.
Transparency on behalf of the software manufacturers (in terms of regulatory status) is crucial for m-Health to become a trusted partner in the healthcare space. Regulatory hurdles aside, other issues such as data management security, app usability, and, above all, patient and clinician engagement with these technologies will ultimately decide the extent of benefit of healthcare apps. For now, we may have to tread carefully whilst looking forward to technologies which facilitate a better quality of life for COPD patients.
Many thanks to Prof Ita Richardson and the Health Products Regulatory Authority for their contributions.