FRANCE | CNIL Publishes Results from its Digital Health Regulatory Sandbox GalleryFRANCE | CNIL Publishes Results from its Digital Health Regulatory Sandbox
2023, August 2023, Data Privacy and Data Protection, Digital Health, EU, France, GDPR, Members-Only, Moderate Update, RWD to Support Reg Decisions, Secondary Use of Existing Data-
RWE 101 – Secondary Use of Existing Data
RWE 101 – Secondary Use of Existing Data
Secondary use of existing data refers to the practice of analyzing data that was collected for a different purpose than the current research question. This approach is becoming increasingly popular in real-world research because of the large amounts of data that are available through various sources, such as electronic health records, administrative databases, and social media.
In many cases, secondary data analysis can provide valuable insights and answer research questions that would otherwise be difficult or impossible to answer with primary data collection. For example, researchers can use existing data to study disease trends, evaluate the effectiveness of health interventions, and identify risk factors for various health outcomes.
Secondary data analysis can also be more cost-effective than primary data collection, as the data has already been collected and often comes at a lower cost than conducting a new study. Additionally, secondary data analysis can allow researchers to study topics that may not have been feasible to study with primary data collection due to ethical or practical limitations.
However, there are also potential limitations to secondary data analysis, such as the lack of control over the quality and accuracy of the data, and the potential for biases and confounding factors that were not accounted for in the original data collection. Therefore, researchers must carefully evaluate the suitability of existing data for their research question and take steps to address any limitations or potential biases in the data.
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RWR Insights | GDPR and the Secondary Use of Existing Data
Secondary use of health data is the processing of health data for purposes other than the initial purposes for which the data were collected. This approach is becoming increasingly popular in real-world research (research that uses real world data to generate real world evidence) because of the large amounts of data that are available through various sources, (e.g., electronic health records, administrative databases, and social media), and the availability of AI-powered analytical tools [1].
In many cases, secondary data analysis can provide valuable insights and answer research questions that would otherwise be difficult or impossible to answer with primary data collection. For example, researchers can use existing data to study disease trends, evaluate the effectiveness of health interventions, and identify risk factors for various health outcomes.
In the world of clinical research we often refer to secondary data as ‘real world data (RWD)’ to distinguish it from data generated through clinical trials. As per FDA guidance, real-world data are data relating to patient health status and/or the delivery of health care routinely collected from a variety of sources. Examples of RWD include data derived from electronic health records, medical claims data, data from product or disease registries, and data gathered from other sources (such as digital health technologies) that can inform on health status [2].
Traditionally, existing healthcare data are collected from medical records and processed to provide insights in to the safety and effectiveness of drugs etc. In Europe, we call these types of studies retrospective non-interventional studies. These are protocol-defined studies that require local regulatory approvals and can only collect data that was collected before the start of the study. This self-limits the usefulness of the research, especially given that the healthcare data will continue to be generated. For these reason, the emphasis is moving from ‘retrospective’ to ‘secondary use of existing data’ which can be both retrospective and prospective. The research is still non-interventional (or observational) because there are no healthcare interventions that impact the clinical management of the patient.
Under the General Data Protection Regulation (GDPR – Regulation EU/2016/676), personal data (especially health and genetic data – Article 9) must be collected and processed lawfully, fairly, and transparently, and individuals have the right to be informed about how their data is being used. This means that researchers should obtain explicit and informed consent from individuals to use their personal data for research purposes and the data should be pseudonymized or anonymized to protect individuals’ privacy [3].
The requirement for explicit informed consent from each individual can become problematic when the intention is to process (analyse) very large healthcare datasets, such as electronic health records in the context of scientific research. This is where GDPR becomes a facilitator, rather than the hindrance it was thought it would be when it was first implemented.
One of the key ways that the GDPR supports the secondary use of health data for research is through the concept of “legitimate interests”. Article 6(1)(f) of the GDPR allows for the processing of personal data if it is necessary for the legitimate interests of the data controller or a third party, provided that those interests do not override the fundamental rights and freedoms of the data subject. Scientific research can be considered a legitimate interest, provided that appropriate safeguards are in place to protect individuals’ rights and freedoms. In addition, the GDPR includes provisions that specifically address the use of health data for scientific research. For example, Article 9(2)(j) allows for the processing of special categories of personal data, such as health data, for scientific research purposes, provided that appropriate safeguards are in place. Whereas, Article 89(1) provides for further processing of existing data for scientific research when appropriate safeguards such as pseudonymisation, no longer permits the identification of data subjects [3].
GDPR indicates that personal data should be gathered for an identifiable purpose or purposes and not further processed for incompatible purposes. Therefore, processing for purposes that are compatible with the purpose of the original gathering and processing of the data are permitted. In addition, the GDPR goes further to indicate that further processing for research purposes are compatible with the original purpose. In the case of the GDPR, this is very positive for RWD processing. However, it is not without difficulties (Section 4.4.4 of the draft CIOMS Real-World Data and Real-World Evidence in Regulatory Decision Making)[4].
Currently, in the context of scientific research, GDPR (especially Article 89(1) is interpreted and implemented differently at the national level. As per recent European Commission reports, more harmonisation of the implementation of GDPR is required at the national Member State level [5] [6].
See visual example below.
This is particularly relevant to the proposed European Health Data Space and the creation of a federated network of health data hubs that will facilitate access to secondary health data, especially for research purposes (HealthData@EU) [7].
As per the recent draft CIOMS report, there is a strong argument that the processing of RWD only works where data subjects have trust and confidence in the institutions and individuals who process data that relate to them, and therefore a strong personal data protection regime is essential to the acceptance and operation of RWD processing. As noted above, further work is needed on issues regarding compatible processing of RWD (secondary use of existing data) in the absence of consent or where data were gathered to form a patient record (Chapter 5 of the draft CIOMS Real-World Data and Real-World Evidence in Regulatory Decision Making)[4].
References
1. World Health Organisation (WHO) – Meeting on Secondary Use of Health Data (13 December 2022)
2. FDA – Real-World Evidence
Link: https://www.fda.gov/science-research/science-and-research-special-topics/real-world-evidence
3. Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation)
Link: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02016R0679-20160504&qid=1687865819117
4. Real-World Data and Real-World Evidence in Regulatory Decision Making. CIOMS Working Group report. Geneva, Switzerland: Council for International Organizations of Medical Sciences (CIOMS), 2023
Link: https://cioms.ch/wp-content/uploads/2020/03/CIOMS-WG-XIII_6June2023_Draft-report-for-comment-1.pdf
5. European Commission, Consumers, Health, Agriculture and Food Executive Agency, Hansen, J., Wilson, P., Verhoeven, E., et al., Assessment of the EU Member States’ rules on health data in the light of GDPR, Publications Office, 2021
Link: https://data.europa.eu/doi/10.2818/546193
6. Study on the appropriate safeguards under Article 89(1) GDPR for the processing of personal data for scientific research – Final Report – EDPS/2019/02-08 (August 2021)
Link: https://edpb.europa.eu/system/files/2022-01/legalstudy_on_the_appropriate_safeguards_89.1.pdf
7. European Commission – Proposal for a regulation – The European Health Data Space (May 2022)
Link: https://health.ec.europa.eu/publications/proposal-regulation-european-health-data-space_en
5. Astellas – U.S. Food and Drug Administration Expands Indication for PROGRAF® for Prevention of Organ Rejection in Adult and Pediatric Lung Transplant Recipients (20 July 2021)
Link: https://newsroom.astellas.us/2021-07-20-U-S-Food-and-Drug-Administration-Expands-Indication-for-PROGRAF-R-for-Prevention-of-Organ-Rejection-in-Adult-and-Pediatric-Lung-Transplant-Recipients?_ga=2.73980498.1553566477.1627827053-1302835671.1627827053
- GLOBAL| CIOMS Publishes Draft Report on Real-World Data and Real-World Evidence in Regulatory Decision Making Gallery
GLOBAL| CIOMS Publishes Draft Report on Real-World Data and Real-World Evidence in Regulatory Decision Making
2023, Data Privacy and Data Protection, Global, June 2023, Members-Only, Minor Update, RWD to Support Reg Decisions, Secondary Use of Existing Data -
RWR Insight | The Difference Between De-Identified and Pseudo-Anonymised Data
16 JULY 2021 – Today, the U.S. Food and Drug Administration (FDA)[1] approved a new use for Prograf[2] (tacrolimus) based on a non-interventional (observational) study providing real-world evidence (RWE)[3] of effectiveness. FDA approved Prograf[2] for use in combination with other immunosuppressant drugs to prevent organ rejection in adult and pediatric patients receiving lung transplantation[1].
Prograf[2], originally approved to prevent organ rejection in patients receiving liver transplants, was later approved to prevent organ rejection for kidney and heart transplants as well. The drug has also been routinely used in clinical practice for patients receiving lung transplants. Today’s action marks the first approval of an immunosuppressant drug to prevent rejection in adults and pediatric patients who receive lung transplants. Prograf[2] is the only approved immunosuppressant drug product for this population[1].
This approval reflects how a well-designed, non-interventional study relying on fit-for-purpose real-world data (RWD)[3], when compared with a suitable control, can be considered adequate and well-controlled under FDA regulations. Specifically, the non-interventional study supporting approval for this new indication used RWD from the U.S. Scientific Registry of Transplant Recipients (SRTR)[4], supported by the Department of Health and Human Services. The data were collected on all lung transplants in the U.S. and were supplemented by information from the Social Security Administration’s Death Master File as a trusted repository of mortality data. A dramatic improvement in outcomes was observed among lung transplant patients receiving Prograf[2] as part of their immunosuppression medications compared to the well-documented natural history of a transplanted drug with no or minimal immunosuppressive therapy[1].
In addition to the RWE from the non-interventional study, randomized controlled trials of Prograf[2] used in other solid organ transplant settings provided confirmatory evidence of effectiveness. Additional clinical trial evidence from research publications supports the independent contribution of Prograf[2] as part of a multi-drug immunosuppressive regimen[1].
Prograf[2] should only be prescribed by physicians experienced in immunosuppressive therapy and management of organ transplant and patients receiving the drug should be managed in facilities equipped and staffed with adequate laboratory and supportive medical resources. Prograf[2] is associated with increased risk of developing lymphoma and other malignancies and is associated with increased susceptibility to bacterial, viral, fungal, and protozoal, including opportunistic infections[1].
FDA granted the approval to Astellas Pharma US, Inc[5].
References
1. FDA Approves New Use of Transplant Drug Based on Real-World Evidence (16 July 2021)
Link: https://www.fda.gov/drugs/drug-safety-and-availability/fda-approves-new-use-transplant-drug-based-real-world-evidence
2. PROGRAF (tacrolimus) – Highlights of Prescribing Information
Link: https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/050708s053,050709s045,210115s005lbl.pdf
3. FDA – Real-World Evidence
Link: https://www.fda.gov/science-research/science-and-research-special-topics/real-world-evidence
4. U.S. Scientific Registry of Transplant Recipients (SRTR)
Link: https://srtr.transplant.hrsa.gov/
5. Astellas – U.S. Food and Drug Administration Expands Indication for PROGRAF® for Prevention of Organ Rejection in Adult and Pediatric Lung Transplant Recipients (20 July 2021)
Link: https://newsroom.astellas.us/2021-07-20-U-S-Food-and-Drug-Administration-Expands-Indication-for-PROGRAF-R-for-Prevention-of-Organ-Rejection-in-Adult-and-Pediatric-Lung-Transplant-Recipients?_ga=2.73980498.1553566477.1627827053-1302835671.1627827053
- ITALY | Ethical and Regulatory Issues in the Processing of Personal Health Data in Observational Research Gallery
ITALY | Ethical and Regulatory Issues in the Processing of Personal Health Data in Observational Research
2023, Data Privacy and Data Protection, EHDS, Italy, May 2023, Members-Only, Secondary Use of Existing Data, Significant Update -
