What is Electronic Health Record (EHR) to Electronic Data Capture (EDC) Integration?

What is Electronic Health Record (EHR) to Electronic Data Capture (EDC) Integration?

Electronic Health Records (EHRs) are the digital version of a patient’s medical records. An Electronic Data Capture (EDC) system is software that stores patient data collected in clinical trials.

Accordingly, Electronic Health Record (EHR) to Electronic Data Capture (EDC) integration involves the use of software to automatically transfer data from the Electronic Health Record (EHR) and populate fields in Electronic Data Capture (EDC) system.

Combined or aggregated Electronic Health Record (EHR) data presents a rich and easily available source of health data. For the clinical research industry, Electronic Health Record (EHR) data contains a wealth of information regarding population health, disease prevalence, and the usage, side effects, and benefits of medical treatments.

Furthermore, clinical research organisations (CROs), sponsors, and biopharma companies can harness the power of EHR data through integration with Electronic Data Capture (EDC) systems.

Advances In Technology Facilitate Automation

EHR to EDC Integration is now at the forefront of industry minds. In fact, a recent report from Deloitte states “The Deloitte Center for Health Solutions set out to understand these organizations’ strategic priorities, and learned that maintaining and expanding R&D, technological transformation, and their global market presence are their immediate focus areas.”

There’s no denying that Covid-19 has forced a more rapid uptake of technology in the life sciences industry, and a shake-up of the list of priorities. However, the transition from where we are now, to where we want to be in the field of EHR to EDC integration, is going to involve immense effort from all of us in the industry. Additionally, there are concerns regarding the risks involved.

Key Industry Players Join Forces on EHR2EDC

It’s encouraging that the imperative nature of this data transfer issue is being prioritised. Key industry players have joined forces in a consortium to drive EHR2EDC. [2]

The EHR2EDC Consortium is a collaboration between Assistance Publique – Hôpitaux de Paris, Astra Zeneca, INSERM – French National Institute of Health and Medical Research, Janssen-Cilag GmbH, Sanofi-Aventis and UCB Biosciences GmbH.

EHR to EDC Challenges Within The UK

One key challenge is that in the UK there is no single system in place. Moreover, some hospitals are still not utilising Electronic Health Record (EHR) systems to their full capacity. Others have developed their own in-house solutions to replace the need to implement an EHR. Unfortunately, there are also some hospitals that are yet to even implement an Electronic Health Record (EHR) system and are falling behind on digital targets set out by the NHS. Additionally, the current situation makes data sharing between hospitals difficult and further complicates studies. Hospitals that have high quality access to data are now starting to be referred to as ‘eSource’ ready sites by the research community.

On a more positive note, the NHS, is making interoperability a priority. The UK’s NHS has committed “to drive interoperability across the health and care system by ensuring that the national standards developed to support the exchange of information and data are adopted and implemented.” Consequently, the NHS is working to standardise systems nationally with HL7® FHIR®. “Through collaboration with healthcare providers (NHS and social care organisations), system vendors (such as EPR and integration engine suppliers) and standards bodies (such as the Professional Record Standards Body (PRSB) and INTEROPen) a number of FHIR profile and specifications have been published and are being implemented. For example – Transfer of Care and CareConnect, with more in development.”

A Solution In Sight With HL7® FHIR®

HL7® (Health Level 7) is a set of international standards used for the transfer of data between software applications used in healthcare. The latest version is called HL7® FHIR® [4] (Fast Healthcare Interoperability Resources). It allows applications to send and receive patient data in a common format.

HL7® FHIR® is powerful because it captures a high degree of detail from a patient’s digital record, whilst also being fast and easy for EHR vendors to implement, using its restful architecture. Electronic Health Record (EHR) vendors such as Epic, Cerner, InterSystems, Allscripts and SystemC, have actively implemented adoption strategies into their development roadmaps. Hence they are already deploying cutting-edge applications in hospitals using HL7® FHIR®.

The sooner we can implement these standards across the board, the faster we reap the benefits.

The Core Benefits of Interoperability

The main benefits of Electronic Health Record (EHR) to Electronic Data Capture (EDC)

integration are well-known. Specifically, they include the following advantages:

1. A reduction in pressure on clinical sites as a result of increased efficiency;
2. Data quality and accessibility improves as we eliminate unnecessary duplication of data and human transcription errors, to create a single-point capture of source data;
3. The efficiency also means studies can be set up more quickly;
4. EHR data could also improve data provenance, while reducing the need for data queries, data cleaning, and source data verification;
5. More rapid completion of EDC forms;
6. Improved data integrity and security;
7. Faster adverse event reporting as a result of almost real-time access to data for review;
8. Better and more tailored patient care.

The benefits to clinical sites save time resource, produce more effective data for research and result in higher levels of patient safety and care quality. Additionally, streamlining site monitoring saves numerous resources for CROs by reducing manual work staff and on-site monitoring visits, hence saving travel costs. Moreover, the overall increase in efficiency and speed delivers cost-saving and profit-driving benefits for sponsors.

Can SDV (Source Document Verification) Bills Be Eliminated Altogether?

Dan Hydes, CEO of IgniteData believes it’s possible. “Roughly 40% of a clinical study expenditure is directed towards Monitoring, of which source document verification (SDV) is a large part, some suggest up to 15% of the entire study budget. If we work towards full EHR to EDC integration, not only can current administrative costs be redirected elsewhere or saved, we could eliminate SDV bills entirely.”

In 2020, Ignite Data received funding from the UK Government (Innovate UK), to support their Archer solution [5]. Archer is a DigiHealth application that significantly enhances the interoperability of Electronic Health Record (EHR) and various research applications such as Electronic Data Capture (EDC).

Archer has received the support of HL7® UK with Technical Chair, Rik Smithies, actively advising on the project. Moreover, IgniteData is committed to working with HL7® FHIR® to further educate UK hospitals on the major benefits of HL7® FHIR®.

References

[1] https://www.deloitte.com/uk/en/insights/industry/life-sciences/pharmaceutical-industrytrends.html

[2] https://www.i-hd.eu/index.cfm/services/research/ehr2edc/

[3] https://digital.nhs.uk/about-nhs-digital/our-work/nhs-digital-data-and-technology-standards/framework/beta—use-of-fhir-based-apis

[4] https://www.hl7.org/fhir/

[5] https://www.ignitedata.com/ignite-data-receive-part-of-90m-continuity-support/