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The European Institute for Innovation through Health Data (i-HD)
Establishing trust in the use of health data
Analysis of Electronic Health Records (EHR) and efficient information sharing can lead to improved treatment of disease, yet it is also important to take account of privacy and security concerns in the re-use of data. We spoke to Professor Dipak Kalra about the European Institute for Innovation through Health Data’s work in supporting best practice in the trustworthy re-use of electronic health records
There are vast quantities of health data available in Europe today, collected within the health systems of all Member States. These data have the potential to offer a rich set of resources for researchers to investigate diseases and improve treatments in a cost effective way. This can bring important benefits to patients, healthcare systems and healthcare funders. However, while analysis of high-quality, interoperable, health data can lead to new insights, medical innovations and improved treatments, it is also important that the data is used responsibly, a challenge which was part of the motivation behind establishing the European Institute for Innovation through Health Data (i~HD). “The institute was set up because many stakeholders recognised that one of the major concerns around the use of health data is trustworthiness, particularly with respect to privacy protection,” says Professor Dipak Kalra, the institute’s President. The institute was founded on a not-for-profit basis to develop and promote best practices in research when re-using electronic health records, both by industry and academia. It is a multi-stakeholder organisation including patients, healthcare providers, funders and decision makers, pharma and the ICT industry and academia. “One of the threads in which we have been most active has been in developing codes of practice. We have developed underlying principles of good practice for using health data,” outlines Professor Kalra.
Experts at the institute are developing standard operating rules that can be adopted by technology providers, hospitals, and pharmaceutical companies, all of whom make extensive use of health data. It is also important to consider the technology that is used in the course of research, a topic which Professor Kalra and his colleagues are addressing. “We’ve also developed a method of assessing software products that support connecting researchers with electronic health records, to check that those technology products do include adequate privacy protection measures. This is a technical and organisational assessment and we have started to award the Quality Seal to organisations and products that meet our standards,” Geert Thienpont explains. The institute has developed a quality assurance seal for research platforms (QS4RP), which provides reassurance to stakeholders on security and privacy Quality Seal for Research Platforms issues, while sociotechnical research into related issues is continuing. The institute is also involved in several other enabling initiatives. “We are beginning to work on educational materials that support stakeholders in understanding the value of health data for research and how it can be adequately protected,” says Professor Kalra. “In another project, we are looking at how custodians of research data can make this available to another research organisations (data sharing): how this can be done in a trustworthy way.”
The institute was set up because we identified the need to create a multi stakeholder platform to maximise the value of health data for the benefit of patients
Health records
The wider goal in this work is to connect the different stakeholders involved in the analysis and use of electronic health records, in order to enable good re-use of data. One major scenario of interest is clinical trials, where a pharmaceutical company has a medicinal product that is ready for large-scale clinical trial testing, and needs to establish that trial. “They need to connect to a number of healthcare sites, some of which may become clinical research sites for that study. Securely analysing large volumes of anonymised hospital electronic health records can help the clinical trial team to identify where there are patients with the specific condition for the study, and therefore where they could conduct the trial,” outlines Professor Kalra. The way in which pharmaceutical companies currently identify relevant hospitals, and that the hospitals then identify patients who could participate in the study, is relatively ad-hoc and errorprone, states Professor Kalra. “Many patients who could have been invited to join a study are missed, and as a consequence the clinical trials take longer than expected, as they take a long time to find the right patients to recruit,” he explains. “That increases the cost of the trial and leads to delays in completing the clinical trial, which then translates into a delay in getting the drug into health systems. This adds to the cost of the drug and delays the benefits of it. We also know that there are many patients who would like to be involved in a clinical trial, but do not manage to connect to a trial relevant to their condition.”
By using electronic health records more efficiently, pharmaceutical companies can
potentially locate the hospitals with ideal participants for a clinical trial more quickly. The same profiling tools that help the company to find the right hospitals can then be used internally within a hospital, to help the hospital find the right patients. “A technical platform supporting the clinical research process could, for example, tag all the patients who have a matching health profile, and the hospital can then contact those patients. This recruitment process can therefore become pro-active, rather than just waiting for suitable patients to routinely attend an outpatient clinic,” explains Professor Kalra. Analysis of health records can also help researchers identify what
course of treatment is best suited to an individual patient. “You can actually study many anonymised patient profiles, in a single hospital or across a region or on a larger scale, and look at which care pathways and treatment plans result in better outcomes,” says Professor Kalra. “You’re basically sub-profiling patients.”
A greater level of precision in profiling is likely to lead to healthcare improvements in terms of identifying the right course of treatment and assessing its likely impact. Many hospitals are improving their ICT infrastructure, and as more data is gathered on more patients, new opportunities arise to analyse it. “We’re seeing that there are opportunities to use data in innovative ways, as we’re collecting more data electronically and it’s being held in better quality systems,” says Professor Kalra. It’s necessary to also gather information on healthy patients in order to identify how treatment could be improved.
“You need control groups as well as disease groups, so you have to look at a large number of patients in order to identify specific findings that may benefit a specific subgroup of patients,” continues Professor Kalra. “We need society to be comfortable with this scaling up, with researchers using this routinely collected data. It is important to reassure patients, privacy protection regulators and the wider public, that this clinical research eco-system can be handled in a trustworthy way. We are working, in collaboration with multiple stakeholder groups, to define these trustworthy practices, promote their adoption, and then to be able to offer some assurance to society. Our contacts with patient organisations, and research findings, all suggest that the public are broadly happy for their health data to be used for health related research, provided that appropriate safeguards are applied.”
The institute is working closely with hospitals to address these areas of concern and to establish good practice. A workshop was held in Brussels in February, attended by representatives from 50 hospitals, all keen to make better use of their electronic health records. “These hospitals want to work together towards responsibly handling privacy protection, through our institute. They also want to work together to improve the quality of their data, so that they have better data, from which they can then work smarter,” outlines Professor Kalra. “We wish to work with hospitals and other custodians of health data to look at the best ways in which they can be trusting of research communities that want to use their data to investigate new research questions,” says Professor Kalra.
Realising the Value from Health Data ~ Improving Care and Research
JOINT EVENT JOINT EVENT September 21-22, 2017
MADRID, SPAIN
The European Institute For Innovation Thr~ugh Health Data
At a glance
Full Institute Name
The European Institute for Innovation through Health Data (i-HD)
Vision
Enriching knowledge and enhancing care through health data.
Website
www.i-hd.eu
Members
http://www.i-hd.eu/members/
Executive board
• Dipak Kalra, President (i-HD) • Mats Sundgren (AstraZeneca) • Veli Stroetmann (Empirica) • Irene Schlünder (TMF) • Sebastian Semler (TMF) • Geert Thienpont (RAMIT) • Pascal Coorevits (EuroRec) • Bart Vannieuwenhuyse (Janssen
Pharmaceuticals)
Contact Details
Professor Dipak Kalra c/o University Hospital Gent - Building 5K3 Unit of Medical Informatics and Statistics De Pintelaan 185 - 9000 Gent (Belgium) E: Dipak.kalra@i-hd.eu W: www.i-hd.eu
Professor Dipak Kalra
Professor Dipak is President of the European Institute for Innovation through Health Data.
Geert Thienpont
Geert Thienpont is a founding member of i~HD and responsible for the QS4RP (Quality Seal for Research Platforms)
