The Telegraph. Thus concerns were expressed about the removal of data from the control of the practice, with a query raised about why the HRSS was necessary if researchers would still have to contact the practice if they wished to directly involve patients in a research project. 2022 Oct 22;9(1):643. doi: 10.1038/s41597-022-01773-w. J Am Med Inform Assoc. 1-866-UH4-CARE (1-866-844-2273) In terms of NPT, there appeared to be a problem with coherence. There was, however, a lack of commitment to, and engagement with, the HRSS on the part of patients, whilst the commitment of doctors and practice staff was to some extent mitigated by concerns about information governance and consent, focusing in particular on downloading electronic patient records with their associated identifiers. Website Accessibility, National Suicide Prevention Lifeline: What is the difference between research and a quality improvement activity? Copyright 2021, the Chinese Medical Association. Consent for the use of personal medical data in research. Information gathered and recorded in association with the care of a patient is confidential. Careers. No, such data must only be stored on UH systems and devices. 1998 Mar 28;316(7136):1000-5. doi: 10.1136/bmj.316.7136.1000. (Staff Practice 1). The use of electronic patient records for medical research: conflicts and contradictions, https://doi.org/10.1186/s12913-015-0783-6, http://ec.europa.eu/justice/data-protection/, http://www.nhs.uk/choiceintheNHS/Rightsandpledges/NHSConstitution/Documents/2013/the-nhs-constitution-for-england-2013.pdf, http://blog.38degrees.org.uk/2014/11/07/its-time-to-protect-your-medical-records/, http://www.dailymail.co.uk/news/article-2784269/Storm-NHS-gives-ahead-patient-database-despite-concerns-Pilot-scheme-involve-1-7million-people-unless-individual-specifically-ops-out.html, http://www.computing.co.uk/ctg/news/2374495/nhs-england-to-forge-ahead-with-unchanged-caredata-plans, http://creativecommons.org/licenses/by/4.0, http://creativecommons.org/publicdomain/zero/1.0/, bmchealthservicesresearch@biomedcentral.com. Patients had been sent information packs about the HRSS pilot, with staff informed in practice meetings. The other authors declare that they have no conflicts of interest related to the subject matter or materials discussed in this article. Use of an opt out as a proxy for consent was experienced as problematic for staff and patients alike, with some patients struggled with the work involved in opting out. Emergent themes were mapped on to the constructs of normalization process theory (NPT) to consider the ways in which sense was made of the work of implementing and integrating the HRSS. Which of the following information is found on the patient registration form? In summary, the belief that an individual has a natural right to privacy appears to be (precariously) balanced with a genuine commitment to support medical research [10]. d. Collector current. As you pass by, you notice that she is frowning at a patient's medical record. The Privacy Rule defines PHI as all "individually identifiable health information" held or transmitted by a covered entity or its business associate, in any form or media, whether electronic, paper, or oral. Medley, Amy M. Buckeridge, David However the other side to this is that there is no way of being sure that those people who do not opt out are happy for their records to be used. An electronic health record (EHR) contains patient health information, such as: An EHR is more than just a computerized version of a paper chart in a provider's office. sharing sensitive information, make sure youre on a federal Employees, physicians, workforce members and those who provide services to or on behalf of UH must immediately report the loss or theft of an electronic device containing PHI or an incident of unauthorized access, use, disclosure, modification or destruction of electronic PHI to the UH Help Desk at 216-844-3327. Databases established for clinical purposes should not be intermingled with databases approved and established for research purposes. For some practice staff the HRSS made perfect sense in terms of the most efficient use of a valuable resource. Published online by Cambridge University Press: See 45 C.F.R. https://doi.org/10.1186/s12913-015-0783-6, DOI: https://doi.org/10.1186/s12913-015-0783-6. Each article was read in entirety to realize the use and number of patients and the medical record items. UH employees who intentionally disclose or use unsecured PHI will be terminated. Questions were raised about why the whole record was taken instead of just the aspects necessary for particular research projects, with concerns expressed in particular about the lack of explicit consent from patients for downloading their electronic records. FOIA The degree to which an individual physician has an ethical responsibility to address inappropriate disclosure depends in part on his or her awareness of the breach, relationship to the patient(s) affected, administrative authority with respect to the records, and authority to act on behalf of the practice or institution. This concern was shared by patients and staff. El Emam, Khaled The types of specialties and types of research were analyzed. As of September 2014 there were 684 GP practices and 13.58M acceptable (research quality) patients in GOLD, of which 5.69M are active (still alive and registered with the GP practice). TTD Number: 1-800-537-7697, Content created by Office for Civil Rights (OCR), U.S. Department of Health & Human Services, has sub items, about HIPAA for Individuals, Employers and Health Information in the Workplace. Today the Code is widely recognized as authoritative ethics guidance for physicians through its Principles of Medical Ethics interpreted in Opinions of AMAs Council on Ethical and Judicial Affairs that address the evolving challenges of contemporary practice. and and International collaboration of clinical medicine research in Taiwan, 1990-2004: a bibliometric analysis. There were four fundamental points of misunderstanding: (1) patients believed they had been selected (rather all patients in the practice were contacted) (2) patients did not understand they may be contacted about involvement in a research project on the basis of information from their medical record, (3) both patients and staff were unaware that data would not be anonymised prior to leaving the practice and (4) that participation required no action, action was only necessary to opt out. Notify the patient about how to access the stored record and for how long the record will be available. So weve always, kind of, wanted to use data efficiently and been frustrated that the NHS doesnt generally use data efficiently, so you know, its certainly ticked the box as far as what we believe should happen about the appropriate use of data (Staff Practice 2). The .gov means its official. Although, views about sharing data from medical records are generally altruistic [5], concerns have been expressed about the use of identifiable data [6] and sharing of data with commercial agencies [7-9]. Authors Nancy E Kass 1 , Marvin R Natowicz, Sara Chandros Hull, Ruth R Faden, Laura Plantinga, Lawrence O Gostin, Julia Slutsman Affiliation 2022 Jan 10;14(1):e21066. Surg Neurol. 2012;22:60718. Generally, it was thought the quantity of information provided was excessive, while practice staff, considering their practice population as a whole, expressed concerns about literacy and language difficulties. The https:// ensures that you are connecting to the See UH Policy PH-28 Breach Notification. What should I do if my laptop or other mobile device containing PHI is stolen or lost? Willison, D. J. and if it was anonymised data Id have no problem with it, but its not (Staff Practice 1). Spector, Logan G. In both practices a GP led involvement. 2009;10:10. Under the Privacy Rule, covered entities may use and disclose PHI for research purposes with individual authorization, or without individual authorization under limited circumstances. Interviews were conducted with all key staff members. Overall coverage of existing databases used for health services and epidemiological research (General Practice Research Database (GPRD), The Health Improvement Network (THIN), QRESEARCH, IMS Mediplus system) is estimated to be only about 20% of NHS patients and focuses on primary healthcare data, with limited linkage to other records. The provider cannot charge you a fee for searching for or retrieving your records. Ministry of Health and Welfare. They started with an interactive task involving working in groups and writing on a flipchart what they knew/understood about the HRSS pilot prior to a re-cap by the researchers and their views and opinions of it before and after the re-cap. 2011. patient understands the treatment offered and the possible outcomes. Does this adequately protect my data? One of the most important duties of a medical assistant is to ____. Jayaraman, Gayatri C. Julie S Snyder, Linda Lilley, Shelly Collins. How do I know whether the project I am considering is research? Files should be password protected and stored on the UH S: drive. Confidentiality of personal health information used for research. In addition, you can log into your UH Personal Health Record and schedule an appointment. Greenhalgh T, Robert G, Bate P, Macfarlane F, Kyriakidou O. Diffusion of innovations in health service organisation: a systematic literature review. 2011;17:11406. > Your Medical Records. The Privacy Rule does not require the health care provider or health plan to share information with other providers or plans. J Chin Med Assoc. Others said they did not see involvement as problematic, as they had nothing to hide. [Bibliometric analysis of scientific articles on epidemiological study of burns in China]. statement and A nationwide rollout of the CPRD was due to begin in the Spring 2014 but was postponed following opposition from senior GPs, privacy campaigners and online campaign groups (such as 38 Degrees) [11]. A provider cannot deny you a copy of your records because you have not paid for the services you have received. EHR systems are built to share information with other health care providers and organizations - such as laboratories, specialists, medical imaging facilities, pharmacies, emergency facilities, and school and workplace clinics . ..we had a meeting last week with [GP lead] and he said that the researchers would interrogate that database, but then they would contact us to contact the patients. Medical records research is also easier for the patients involved in the study. The evaluation team played no part in the design or implementation of the HRSS pilot. NHS medical records database halted amid concerns: http://blog.38degrees.org.uk/2014/11/07/its-time-to-protect-your-medical-records/. Benise is trying to figure out how to make all of those changes to the record. government site. The HRSS sought to extract electronic records from across health and social care sectors and to transfer them together with associated identifiers (such as name, address, date of birth) to a designated safe haven (in which information is processed independently of both the data source and the researcher that requires the data). official website and that any information you provide is encrypted A medical record received from another physician should be ___. Practice staff were concerned about releasing identifiable patient data and the associated responsibilities of information governance. Publication performance and research output of neurology and neurosurgery training institutes in India: a 5-year analysis. There are two ways to de-identify data. There was however explicit discussion about the need to balance public good against the risks of adversely affecting the trust people have in doctors and the medical system. The budget of the National Institutes of Health, for example, was $20,298 million in 2001, having more than doubled from a budget of $9,218 million 10 years before. (FG4 Practice 2). How is it detected? The CPRD is ideologically driven leaving questions around the acceptability of implementing and integrating the necessary processes to enable electronic patient records to be used for the purposes of research unresolved. ), National Health Information Privacy: Regulations Under the Health Insurance Portability and Accountability Act,, Use of Personal Medical Records for Research Purposes,, Using Patient-Identifiable Data for Observational Research and Audit,, The Threat to Medical Records Research,, The Impact of Requiring Patient Authorization for Use of Data in Medical Records Research,, Thromboembolism and Oral Contraceptives: An Epidemiologic Case-Control Study,, Risk of Uterine Rupture During Labor Among Women with Prior Cesarean Delivery,, Quality of Medical Care Delivered to Medicare Beneficiaries: A Profile at State and National Levels,, Researchers' Access to Patient Records: An Analysis of the Ethical Problems,, http://www.nih.gov/news/budgetFY2002/FY2001investments.htm#totalbudget, +(last+visited+July+2,+2001).>Google Scholar, http://www4.od.nih.gov/ofm/PRIMER97/page38.stm, +(last+visited+July+10,+2001).>Google Scholar. And I think, as Amelia was saying, its clarity of the whole situation about what this data is going to be used for (FG 4 Practice 1). The use of an opt out as opposed to an opt in is particularly controversial. PubMed Central Sometimes I bring my work laptop home to complete work. All participants received an information sheet and provided written consent. Anyone you share the following link with will be able to read this content: Sorry, a shareable link is not currently available for this article. Of 800 patients approached, 79 (10%) indicated their willingness to participate in the evaluation and 50 finally participated, the majority of whom reported not opting out of the HRSS pilot project. Following MacFarlane and OReilly-de Brun [15], themes from interviews and focus groups with practice staff and patients were then mapped onto the constructs of the Normalization Process Theory (NPT). Northrup, David The data presented in this paper were collected prior to electronic patient records being downloaded. (FG 2 Practice 2). Pritts, Joy L. The best place to interview a patient is ____. Collen MF. For appointments/referrals: Kass, Nancy E. 1987;28:1113. J Law Med Ethics. Correspondence to Alternatively, data is de-identified when an expert determines there is a very small risk that the recipient could identify the individual. The GOLD database covers approximately 8.8% of the UK population, including practices in England, Northern Ireland, Scotland and Wales. Roffey, Tyson Weitzman ER, Kaci L, Mandl KD. Privacy The Privacy Rule defines research as a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge. To clarify whether your project is research, seek clarification from the UH Clinical Research Center (UHCRC). The importance of strong governance procedures was stressed together with the need to communicate the fact that data loss or personal identification has never occurred as a result of using electronic records for research. Neisa, Angelica eCollection 2022 Jan. Public Health Ethics. 2022 Sep 12;29(10):1818-1822. doi: 10.1093/jamia/ocac112. It was suggested such a resource would support clinical innovation and strengthen evidence of effectiveness resulting in improvements in health outcomes, with drug safety particularly singled out. Madhugiri VS. You do not have the right to access a providers psychotherapy notes. Disclosing information to third parties for commercial purposes without consent undermines trust, violates principles of informed consent and confidentiality, and may harm the integrity of the patient-physician relationship. Kalarickal, Rosemarie J. Historically, less than 0.5% of patients from these practices have opted out of their records being included. However, a provider may charge for the reasonable costs for copying and mailing the records. UH Policy R-3 Uses and Disclosures of PHI for Research, UH Investigator Manual for IRB Submissions: Chapter 3 Regulatory Classifications, Quality Improvements Activities, http://www.hhs.gov/ocr/privacy/hipaa/understanding/coveredentities/De-identification/guidance.html, UH Policy PH-15, De-identifying Protected Health Information (PHI), UH Policy PH-16, Limited Data Set: Permitted Purposes for Use/Disclosure, Research SOP GA-102 Use and Disclosure of Protected Health Information Preparatory to Research, the individuals past, present or future physical or mental health or condition; or, the provision of health care to the individual; or. 2010;12:e14. weve handed over un-anonymised patient data to sources who arent directly involved in the patient care, which in terms of information governance is a bit of a big no-no really. Additionally, you may contact the Compliance and Ethics Department at 216-767-8227 or email Compliance@UHhospitals.org. Abelson, J. There was also confusion between the HRSS and the summary care record scheme on the part of patients and staff. Neisa, Angelica Others with the same background either in research or the health service, although acknowledging the potential value of the HRSS, opted out for fear their medical record would be recognised by other researchers. SM1: But when it was first sold to us we did get really excited about it initially because we thought we cant believe that, in this day and age, there isnt this facility already to have information that researchers can tap into and to really develop some evidence based medicine that was really exciting and we thought we should definitely be involved in that. Concerns about balancing privacy against the public good are at the heart of the decision to be involved in any research; arguably a particular problem associated with the use of patient records for research is that there is no direct, visible link between the provision of data and the research for which it is used. Moreover, although people in key roles in the practice developed a good understanding of the HRSS, this was not the case for people who were more peripheral.