In an Opinion piece published in The BMJ recently, Dipak Kalra called for a recalibration of our approach to data protection.  He suggested we should reconsider how we value health data as a societal good, and how we deliver transparency to the public. I would like to add my voice to his call, but also add a note of caution against the use of the concept of ownership with respect to health data. Legally, the term ownership implies that ownership (title) can be transferred to someone else with the first “owner”—the data subject—no longer having any rights over the data. This sits poorly with health data, where the data subject—the patient—continues to have an interest in ensuring that his/her data are used appropriately and with respect for their privacy, and does nothing to improve access to data or its reuse. [2,3] In line with Kalra’s call, the recalibration of data protection should embrace the concept of data stewards, rather than data owners.
Placing the discussion on data protection in the wider context of the use of digital health tools, it is important to recall that digital health tools and services are not new in European healthcare. The quest to introduce standardised EHRs has been pursued in most European countries since the 1980s, and endeavours to bring the right information, to the right person, at the right time with the aid of digital tools also began then. [4,5] But late 2021 marks an ideal time to re-evaluate how we want to integrate digital tools into our healthcare systems, because responding to covid 19 has made European healthcare stakeholders think differently about the role of digital tools in healthcare. We have questioned when face-to-face consultation is really needed and when it may be replaced or augmented by remote consultation; we have recognised the value of remote monitoring which allows patients with long-term conditions to be supported in their own homes; and we have learned significant lessons about the value of access to accurate epidemiological data.
The appetite of data scientists, clinical scientists, engineers, and healthcare professionals to develop new and exciting digital health tools is significant and is not abating—one needs only to look at the ORCHA app library and similar initiatives, or the growing number of devices and software certified under the Medical Device Regulation. However, their integration into everyday healthcare delivery remains slow. EHRs are still not accessible in a seamlessly interoperable manner, the data from many patient-held devices, like blood glucose monitors, are still largely unused by physicians, and reimbursement for remote care or the prescription of digital therapeutics is still in its infancy in most European countries. [7-9]
It is time for policy, regulation, and administration to catch up with the technology. We have a wealth of apps that could help patients monitor symptoms, report outcomes, and help patients with medication, regime compliance, and to embrace healthier options, but until these apps and tools are prescribable, supported, and their output is integrated into the records held by healthcare professionals, they will remain luxury items for those who can afford them, have the skills to use them, and the interest in maintaining their own records. The benefit to whole populations will remain elusive unless these tools become part of the healthcare system—in short when digital health is no longer a standalone concept, but simply a core part of the way in which healthcare services are provided.
EU level policy is moving in the right direction, the draft Data Governance Act is paving the way for the European Health Data Space, the draft legislation on AI and the proposed Data Act will create legal frameworks in which it is easier to share data and use it to develop intelligent medical devices and tools. But EU level policy can only go so far in influencing healthcare delivery. Healthcare policy remains an area governed mainly by national and regional laws and policies, it is therefore crucial that the stakeholders at those levels—such as, local patient groups and national medical chambers—engage with policy makers to push for better inclusion of digital into every day care. Moreover, the call does not have to come solely from those with a professional interest, as the electors of our policy makers, as citizens with a vote, we can use our voices to ensure that the growth in the use of digital health we saw in response to covid-19 is not lost, and that we build successfully on the gains made.
This is the second article of a series being published ahead of the European Patients’ Forum Virtual Congress which takes place from 26-29 October 2021, where The BMJ will co-lead a session “Discussing Health Data between access, control and ownership”.
Petra Wilson, managing director, Health Connect Partners.
Competing interests: PW works as a senior advisor in the large international consultancy firm FTI Consulting, leading the healthcare team in Brussels. Her previous professional experience include CEO of the International Diabetes Federation, promoting better and more integrated care for people living with diabetes; a seven year period in eHealth technology with Cisco and eight years with the European Commission working on eHealth policy, and in particular use of patient data to drive better care.
- Evans, B.J, Much Ado about Data Ownership 25 Harv. J. L. & Tech. 69 (2011-2012)
- Ballantyne A. How should we think about clinical data ownership? Journal of Medical Ethics 2020;46:289-294.
- Li L, Novillo-Ortiz D, Azzopardi-Muscat N, Kostkova P. Digital Data Sources and Their Impact on People’s Health: A Systematic Review of Systematic Reviews. Front Public Health. 2021 May 5;9:645260. doi: 10.3389/fpubh.2021.645260. PMID: 34026711; PMCID: PMC8131671.
- Kruse, C.S., Kristof, C., Jones, B. et al. Barriers to Electronic Health Record Adoption: a Systematic Literature Review. J Med Syst 40, 252 (2016). https://doi.org/10.1007/s10916-016-0628-9
- Warren LR, Clarke J, Arora S, et al Improving data sharing between acute hospitals in England: an overview of health record system distribution and retrospective observational analysis of inter-hospital transitions of care BMJ Open 2019;9:e031637. doi: 10.1136/bmjopen-2019-031637
- Victoria L Tiase, William Hull, Mary M McFarland, Katherine A Sward, Guilherme Del Fiol, Catherine Staes, Charlene Weir, Mollie R Cummins, Patient-generated health data and electronic health record integration: a scoping review, JAMIA Open, Volume 3, Issue 4, December 2020, Pages 619–627, https://doi.org/10.1093/jamiaopen/ooaa052
- Roberto Verna., et al. “Digital Therapeutics-What they are, what they will be”. Acta Scientific Medical Sciences 4.3 (2020): 01-09.