Abstract
BackgroundClinical free-text data (eg, outpatient letters or nursing notes) represent a vast, untapped source of rich information that, if more accessible for research, would clarify and supplement information coded in structured data fields. Data usually need to be deidentified or anonymized before they can be reused for research, but there is a lack of established guidelines to govern effective deidentification and use of free-text information and avoid damaging data utility as a by-product.ObjectiveThis study aimed to develop recommendations for the creation of data governance standards to integrate with existing frameworks for personal data use, to enable free-text data to be used safely for research for patient and public benefit.MethodsWe outlined data protection legislation and regulations relating to the United Kingdom for context and conducted a rapid literature review and UK-based case studies to explore data governance models used in working with free-text data. We also engaged with stakeholders, including text-mining researchers and the general public, to explore perceived barriers and solutions in working with clinical free-text.ResultsWe proposed a set of recommendations, including the need for authoritative guidance on data governance for the reuse of free-text data, to ensure public transparency in data flows and uses, to treat deidentified free-text data as potentially identifiable with use limited to accredited data safe havens, and to commit to a culture of continuous improvement to understand the relationships between the efficacy of deidentification and reidentification risks, so this can be communicated to all stakeholders.ConclusionsBy drawing together the findings of a combination of activities, we present a position paper to contribute to the development of data governance standards for the reuse of clinical free-text data for secondary purposes. While working in accordance with existing data governance frameworks, there is a need for further work to take forward the recommendations we have proposed, with commitment and investment, to assure and expand the safe reuse of clinical free-text data for public benefit.
Highlights
BackgroundStructured electronic health records (EHRs) have long been used in large-scale research to create new knowledge to inform clinical care, practice, and policy
Free-text data given in confidence, such as in a physician-patient consultation, are subject to the same common law duty of confidentiality Clinical Practice Research Datalink (CPRD) (CLDC) [11] principles and professional practice as for structured, coded data
The Caldicott Principles [11] set out fundamental good practices for the protection of information that could identify an individual and highlight that data sharing can be as important as the duty to protect confidentiality. Within these principles and in the Information Commissioner’s Office guidance on data sharing and anonymization, there is nothing stated about free-text data (Table 1)
Summary
BackgroundStructured electronic health records (EHRs) have long been used in large-scale research to create new knowledge to inform clinical care, practice, and policy. EHR data contain free-text components, including notes made at consultations and referral letters, which, by definition, are unstructured As such, they tend to be less available beyond the immediate setting and are typically not readily available for secondary uses such as research or service improvement. Clinical free-text data represent a vast, untapped source of rich information to guide research and clinical care, including patient-specific context and details that clarify and supplement information coded in structured data fields. Data usually need to be deidentified or anonymized before they can be reused for research, but there is a lack of established guidelines to govern effective deidentification and use of free-text information and avoid damaging data utility as a by-product. While working in accordance with existing data governance frameworks, there is a need for further work to take forward the recommendations we have proposed, with commitment and investment, to assure and expand the safe reuse of clinical free-text data for public benefit
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a call
