Introduction

Patient portals are increasingly used to facilitate access to personal health information and to facilitate communication between patients and healthcare professionals, as well as to perform administrative tasks, such as appointment bookings and prescription renewals [1]. In some countries, patients are also provided with online record access (ORA), i.e. access to their electronic health records (EHRs) [2], sometimes referred to as patient accessible EHRs (PAEHRs) [3][4], or when referring specifically to the notes in the record, ‘open notes’ [5]. The importance of ensuring patients’ access to health data has also been highlighted by policy makers internationally. In the US, a federal rule from the 21st Century Cures Act mandated US healthcare providers to offer patients access to all the health information in their electronic medical records without charge [6]. In Europe, the proposal for a European Health Data Space aims to both empower people to control and utilize their health data in their home country or in other Member States, as well as offer “a consistent, trustworthy and efficient framework to use health data for research, innovation, policy-making and regulatory activities, while ensuring full compliance with the EU's high data protection standards” [7].

Yet, implementation of ORA varies greatly across Europe, and some countries will have a long way to go to reach the ambitions of the EHDS. Researchers from the NORDeHEALTH research project [8], have launched an international research program, the Health Data (HEDA) program [9]. In collaboration, the HEDA program and EFMI’s WG Citizen and Health Data (CHD) are looking to explore how the different components of EHDS can help to move progress forward. In this panel, we focus on Article 3 of the EHDS proposal, which describes the rights of natural persons in relation to the primary use of their personal electronic health data.   

Rationale

Patient portals and ORA are increasingly being implemented across Europe. We will use the EHDS proposal to describe the requirements suggested for patients and informal caregivers ORA, and for patients control over record access. We have invited panel participants to introduce and discuss five core aspects of EHDS that will different countries, representing five different stages of and approaches to patients’ ORA implementation.

Programme

The planned duration of the panel is 90 minutes. Interactive tools will be used to gain an overview of the audiences’ insights into their countries’ current ORA implementation. 

0-10 min. Maria Hägglund will introduce the topic of ORA and the EHDS, and the objectives and outline of the panel.

10-20 min. RIGHT TO ACCESS: the EHDS proposal clearly states that “natural persons shall have the right to access their personal electronic health data” immediately, free of charge and in an easily readable, consolidated and accessible form [7]. Bo Wang, PhD candidate at the Norwegian Centre for E-health Research, will present results from the NORDeHEALTH project on patients experiences of ORA.  

20-30 min. PROXY ACCESS will be an EHDS requirement, for parents/legal guardians, but also for patients to appoint another person of their own choice. Josefin Hagström, PhD candidate at Uppsala University, will discuss how parents’ ORA differ between the NORDeHEALTH countries [10] and what this could mean for streamlining proxy access across Europe.  

30-40 min. INSERT OWN ELECTRONIC HEALTH DATA: Maria Hägglund, associate professor in health informatics at Uppsala University and PI for NORDeHEALTH, will discuss patient-generated data, and the EHDS requirement that “natural persons may insert their electronic health data in their own EHR” or in the EHR of a person they have proxy access for [7]. Swedish patients were previously able to comment in their electronic health records [11], and we will discuss what this function has been used for, and how future solutions could be designed.  

40-50 min. REQUEST RECTIFICATION: the NORDeHEALTH research indicates that many patients with ORA finds errors in their EHR. Dr Anna Kharko, project co-ordinator for NORDeHEALTH, will present these results, and relate these to the EHDS statement that “natural persons can easily request rectification online” [7].

50-60 min. ACCESS CONTROL: EHDS proposes increased access control for natural persons, to both be able to request that electronic health data is made accessible to actors in the healt or social security sector, but also to have the right to restrict access. Dr Charlotte Blease, is a philosopher of medicine and a healthcare ethicist at Uppsala University, and she will discuss access control in relation to results from the NORDeHEALTH project, but also from an ethical perspective.

60-90 min. Anne Moen and Isabella Scandurra will lead the discussion with the panel participants exploring their views on the EHDS proposal and how it will change patients ORA in the near future, taking the panelist’s summaries as starting point.

The EFMI CHD working group will follow-up and plan the next steps to advance the vision for ORA, equipping citizens with solutions to actively use their health data.  

Acknowledgement

NordForsk funds the project “NORDeHEALTH” (100477) and FORTE – the Swedish Research Council for Health, Working Life and Welfare funds the research project “Beyond Implementation of eHealth” (2020-01229). Further support is from Gravitate-Health, funded by the Innovative Medicines Initiative 2 Joint Undertaking (agreement No 945334, 2020-2025), receiving support from the European Union Horizon 2020 research and innovation programme, European Federation of Pharmaceutical Industries and Associations [EFPIA] and Datapharm Limited.

References

Fraccaro P, Vigo M, Balatsoukas P, Buchan IE, Peek N, and van der Veer SN, “Patient Portal Adoption Rates: A Systematic Literature Review and Meta-Analysis” Stud. Health Technol. Inform., vol. 245, pp. 79–83, 2017.

Hägglund M, DesRoches C, Petersen C, and Scandurra I, “Patients’ access to health records” BMJ, vol. 367, p. l5725, Oct. 2019.

Moll J, et al., “Patients’ Experiences of Accessing Their Electronic Health Records: National Patient Survey in Sweden” J Med Internet Res, vol. 20, no. 11, p. e278, 2018.

Hägglund M and Scandurra I, “Patients’ Online Access to Electronic Health Records: Current Status and Experiences from the Implementation in Sweden” Stud Heal. Technol Inf., vol. 245, pp. 723–727, 2017.

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Salmi L, Blease C, Hägglund M, Walker J, DesRoches CM. US policy requires immediate release of records to patients. BMJ. 2021;372. https://www.bmj.com/content/372/bmj.n426

A European Health Data Space for people and science [Internet]. European Commission - European Commission. https://ec.europa.eu/commission/presscorner/detail/en/ip_22_2711

Hägglund M, “Nordic countries lead new initiative on patient access to EHRs” BMJ Opinion, 2021.

HEDA program, https://www.hedaprogram.com

Hagström J, Scandurra I, Moll J, Blease C, Haage B, Hörhammer I, Hägglund M. Minor and Parental Access to Electronic Health Records: Differences Across Four Countries. Stud Health Technol Inform. 2022 May 25;294:495-499. doi: 10.3233/SHTI220508. PMID: 35612129.

Hägglund M, “Electronic health records in Sweden—how can we go from transparency to collaboration?”, The BMJ Opinion, Jun. 23, 2017. https://blogs.bmj.com/bmj/2017/06/23/maria-hagglund-electronic-health-records-in-sweden-how-can-we-go-transparency-to-collaboration/ (accessed Mar. 10, 2022)