19 February 2018

#KCR_Trends: Apple’s Health Records - what impact does it have on global clinical trials industry?

Apple has announced at the end of Jan 2018, along with the recent iOS update, adding a new feature to its Health app - Health Records (here). The feature was developed to make patients’ life easier by collecting all their medical records from different healthcare providers under one click.

Apple called its new capability a “significant” and “effortless” solution. With the recent industry focus on utilization of big data to facilitate clinical trials conduct, Medidata Solutions, Mobile Health principal claims via Outsourcing-Pharma.com that this new feature could “fundamentally” change the way research is conducted (here).

Can this app change the industry?

The solution Apple is proposing has undoubtedly a tremendous potential. This could be the new smart tool allowing to collect data directly from patients, in line with the BYOD (Bring Your Own Device) trend in the industry. It could also possibly facilitate the recruitment process, by making automatic pre-screening using data stored in the app.

Keeping in mind that e-solutions ongoingly shape the future of research, we should also realize the potential challenges associated with these innovations. This can simply not be underestimated when planning and conducting unbiased clinical research. One of the basis of clinical research is randomness of patient’s inclusion. Can we really assume that Apple’s solution is randomly distributed across worldwide population or even regions?

Let’s agree: today the mobile world is entirely dominated by Android and iOS operating systems. New Apple Health Records feature is only available for iOS users, whose distribution across the world is following certain trends (see the map below). Standard Apple-user profile (as published in the company’s 2018 report here) is male or female in the age of 18 to 45, high earner professional (from student to executive), from middle to upper class. That, again, clearly narrows the group of potential research subjects, lowering the potential randomness of acquired data.

Near or further future of clinical trials?

Current R&D solutions focus on global execution standardization. Patient technology access across regions is very diverse for assorted reasons. Implementing technologies like Apple Health Records to support worldwide trials execution is clearly the future of clinical research, however it should come with an open debate about global trial execution implications and potential impact on research data. In this case, saying that the new is just better, would be too simple.

Android vs iOS market share in 2015

Source: deviceatlas


About KCR
KCR is a Contract Research Organization (CRO) providing clinical development solutions for the pharmaceutical, biotechnology and medical device industries. The company supports clients with full-service capabilities across three main services: Trial Execution (TE), Functional Service Provision (FS) and Late Phase (LP) over a broad range of therapeutic areas. KCR operates across four main regions: North America (NA), Western Europe (WE), Central Europe (CE) and Eastern Europe (EE) with hubs located in Boston, US, Berlin, Germany, Warsaw, Poland and Kiev, Ukraine respectively. The company’s geographical set up suits perfectly to deliver optimized trial execution strategies for life-changing therapies.

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