Digital health has huge potential for both medical device and pharmaceutical clinical trials. But interoperability – the way that data is exchanged between connected devices and platforms – remains a hurdle. Nonetheless, Joe Dustin, principle of mobile health at medical device software firm Medidata, says recent developments look promising.
Joe Dustin
Joe Dustin
In January, Apple released the Health Records feature in IOS 11.3 (beta) that allows users to aggregate their own health data from disparate electronic health records (EHR) on their iPhone. This not only has the potential to change the way patients are involved in their own care, it could also fundamentally change the way research is conducted in regulated clinical trials.
My view is that with health records, Apple doesn’t want user data, but rather it wants to provide the platform to use data in a secure manner to unlock value through easy and informative user experiences.
By comparison, Microsoft recently announced it was discontinuing the HealthVault Insights app. It was a smart move on Microsoft’s part, because Apple just enabled the same thing, but on every single iPhone as a core component of iOS. Hopefully what will follow will be an Android equivalent for true global adoption perhaps from Google Fit or Samsung, though it’s clear they will be playing catch-up.
Why does this matter to medtech? Every clinical development industry event tries to address EHR integration in their agendas. If consumers, patients and people can now aggregate their own health data, they will share it. Very soon, the systems used to run clinical trials will be able to consume eSource data directly from patients inherently bypassing the need for an enterprise-style, costly EHR integration. Patients would also have an easier way to get their data back from procedures performed on them in a clinical trial, a key request by patient advocacy groups for years.
Apple Health Records could also enhance patient recruitment in clinical trials. Patients are rarely informed about clinical trials even when they could be a good fit. Our industry struggles with this problem, and finding the right people to participate could be made easier by Apple Health Records. Once the feature is utilised by more people who share their data with third-party services, new apps, or even patient communities around a specific disease, it will enable a direct connection to patients and allow for solicited outreach to the right people at the right time. Apple Health Records could be used to match people with clinical trials in a much faster and cost-effective manner than any solution on the market today, which in many cases is only based on past experience and retrospective databases.
We’re seeing signs that clinical trials are becoming more virtual as new mobile applications are created to recruit, enroll, engage and receive data from patients with less burden on their everyday life. We have seen virtual clinical trials pave the way for a future that is quickly evolving.
GlaxoSmithKline’s Parade study launched in 2016 was a virtual research study and the very first ResearchKit application released by a major pharmaceutical company. This app had an enrollment and registration step in the patient onboarding workflow to ingest data from Apple’s HealthKit, which included simple demographics. Now, the next time a research app is released, people will have the option to share their health records data as another source inside HealthKit. This opens possibilities for researchers, medtech and pharmaceutical companies that want to improve the patient user experience, which has the potential to attract more participation in clinical trials.
In a technology-agnostic example, the Patient Centered Outcomes Research Institute (PCORI) funded the Adaptable study, which uses EHR/EMR data to identify potential study participants through five cardiovascular phenotypic indicators. Eligible patients are invited to join the study remotely and share health and lifestyle related data in a central study database, with individual patient data being reported back to the healthcare provider for possible inclusion in the EHR/EMR records.
Even five years ago, interoperability was previously nothing more than a good talking point, but efforts like these signal a shift toward a new way of thinking about health data integration.
