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Security and privacy in electronic health records: a systematic literature review.

Open access

Fernández-Alemán, José Luis, Señor, Inmaculada Carrión, Lozoya, Pedro Ángel Oliver, Toval, Ambrosio·2013·Journal of Biomedical Informatics

DOI 10.1016/j.jbi.2012.12.003

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Abstract

Objective To report the results of a systematic literature review concerning the security and privacy of electronic health record (EHR) systems.Data sources Original articles written in English found in MEDLINE, ACM Digital Library, Wiley InterScience, IEEE Digital Library, Science@Direct, MetaPress, ERIC, CINAHL and Trip Database.Study selection Only those articles dealing with the security and privacy of EHR systems.Data extraction The extraction of 775 articles using a predefined search string, the outcome of which was reviewed by three authors and checked by a fourth.Results A total of 49 articles were selected, of which 26 used standards or regulations related to the privacy and security of EHR data. The most widely used regulations are the Health Insurance Portability and Accountability Act (HIPAA) and the European Data Protection Directive 95/46/EC. We found 23 articles that used symmetric key and/or asymmetric key schemes and 13 articles that employed the pseudo anonymity technique in EHR systems. A total of 11 articles propose the use of a digital signature scheme based on PKI (Public Key Infrastructure) and 13 articles propose a login/password (seven of them combined with a digital certificate or PIN) for authentication. The preferred access control model appears to be Role-Based Access Control (RBAC), since it is used in 27 studies. Ten of these studies discuss who should define the EHR systems' roles. Eleven studies discuss who should provide access to EHR data: patients or health entities. Sixteen of the articles reviewed indicate that it is necessary to override defined access policies in the case of an emergency. In 25 articles an audit-log of the system is produced. Only four studies mention that system users and/or health staff should be trained in security and privacy.Conclusions Recent years have witnessed the design of standards and the promulgation of directives concerning security and privacy in EHR systems. However, more work should be done to adopt these regulations and to deploy secure EHR systems.

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“Therefore, it is essential to enforce efficient data querying and sharing for securing electronic medical records in cloud computing [8].”
Background
Assessing staff awareness and effectiveness of educational training on IT security and privacy in a large healthcare organization
Arain, M. A., Tarraf, R. C., & Ahmad, A. (2019) · Journal of Multidisciplinary Healthcare · doi:10.2147/jmdh.s183275 · Cited by 43
“Although electronic information systems offer numerous benefits, health information stored in an electronic system poses unique risks to privacy and security.(2,3) Risks to IT security and privacy can include things such as copying or sharing of username/password, accidental disclosure of patient information, abuse of…”
Background
Security framework for cloud based electronic health record (EHR) system
Ganiga, R., Pai, R. M., Pai, M. M. M., & Sinha, R. K. (2019) · International Journal of Electrical and Computer Engineering (IJECE) · doi:10.11591/ijece.v10i1.pp455-466 · Cited by 42
“Fernandez Aleman et al [16] mainly focuses on privacy and security issues in healthcare data when it is in transit.”
Background
Efficient Identity-Based Distributed Decryption Scheme for Electronic Personal Health Record Sharing System
Zhang, Y., He, D., Obaidat, M. S., Vijayakumar, P., & Hsiao, K.-F. (2020) · IEEE Journal on Selected Areas in Communications · doi:10.1109/jsac.2020.3020656 · Cited by 42
“As mentioned in [7], some password-based schemes and digital signature schemes based on Public Key Infrastructure (PKI) have been proposed for authentication.”
Background
Taxonomic framework for factors influencing ERMS adoption in organisations of higher professional education
Mukred, M., Yusof, Z. M., Mokhtar, U. A., & Fauzi, F. (2018) · Journal of Information Science · doi:10.1177/0165551518783133 · Cited by 51
A Step in the Right Direction – Understanding Privacy Concerns and Perceived Sensitivity of Fitness Trackers
Lidynia, C., Brauner, P., & Ziefle, M. (2017) · Advances in intelligent systems and computing · doi:10.1007/978-3-319-60639-2_5 · Cited by 39
Perceived trust and professional identity threat in AI-based clinical decision support systems: scenario-based experimental study on AI process design features
Ackerhans, S., Wehkamp, K., Petzina, R., Dumitrescu, D., & Schultz, C. (2025) · JMIR Formative Research · doi:10.2196/64266 · Cited by 38
“In addition, the use of digital signatures and the monitoring of user credentials play a critical role in safeguarding patient information and maintaining trust in the health care system [10,32].”
Research communities in cyber security: A comprehensive literature review
Katsikeas, S., Johnson, P., Ekstedt, M., & Lagerström, R. (2021) · Computer Science Review · doi:10.1016/j.cosrev.2021.100431 · Cited by 41
Mobile Healthcare Adoption among Patients in a Developing Country Environment: Exploring the Influence of Age and Gender Differences
Faqih, K. M. S., & Jaradat, M.-I. R. M. (2015) · International Business Research · doi:10.5539/ibr.v8n9p142 · Cited by 44
An integrated framework for securing semi-structured health records
Amato, F., Pietro, G. D., Esposito, M., & Mazzocca, N. (2015) · Knowledge-Based Systems · doi:10.1016/j.knosys.2015.02.004 · Cited by 38
Challenges in patient safety improvement research in the era of electronic health records
Russo, E. M., Sittig, D. F., Murphy, D. R., & Singh, H. (2016) · Healthcare · doi:10.1016/j.hjdsi.2016.06.005 · Cited by 42
Security and Privacy Issues in Ehealthcare Systems: Towards Trusted Services
Ahmed, I., & Mousa, A. (2016) · International Journal of Advanced Computer Science and Applications · doi:10.14569/ijacsa.2016.070933 · Cited by 38
“In this context, electronic healthcare systems (EHRs) employee such rules and thus were categorized as security critical systems [2].”
Background
Deep Arm/Ear-ECG Image Learning for Highly Wearable Biometric Human Identification
Zhang, Q., & Zhou, D. (2017) · Annals of Biomedical Engineering · doi:10.1007/s10439-017-1944-z · Cited by 37
Access control and privilege management in electronic health record: a systematic literature review
Jayabalan, M., & O’Daniel, T. (2016) · Journal of Medical Systems · doi:10.1007/s10916-016-0589-z · Cited by 39
Lightweight Collaborative Authentication With Key Protection for Smart Electronic Health Record System
Feng, Q., He, D., Wang, H., Zhou, L., & Choo, K. R. (2019) · IEEE Sensors Journal · doi:10.1109/jsen.2019.2949717 · Cited by 36
“[3], a SEHR system should define a way for visitors to prove their ownership or”
Background
Quantum Diffie–Hellman Extended to Dynamic Quantum Group Key Agreement for e-Healthcare Multi-Agent Systems in Smart Cities
Naresh, V. S., Nasralla, M. M., Reddi, S., & García‐Magariño, I. (2020) · Sensors · doi:10.3390/s20143940 · Cited by 36
A secure blockchain-assisted authentication framework for electronic health records
Kumar, V., Ali, R., & Sharma, P. K. (2024) · International Journal of Information Technology · doi:10.1007/s41870-023-01705-w · Cited by 34
“Due to the widespread adoption of digital technology and the information revolution, the shift from paper-based healthcare records to Electronic Health Records (EHR) has become critical [1].”
Towards a Universal Privacy Model for Electronic Health Record Systems: An Ontology and Machine Learning Approach
Nowrozy, R., Ahmed, K. E. U., Wang, H., & McIntosh, T. R. (2023) · Informatics · doi:10.3390/informatics10030060 · Cited by 38
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Sai, G. H., Tripathi, K., & Tyagi, A. K. (2022) · Lecture notes in networks and systems · doi:10.1007/978-981-19-1142-2_37 · Cited by 33
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Sahi, A., Lai, D., & Li, Y. (2021) · IEEE Access · doi:10.1109/access.2021.3098708 · Cited by 33
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“As there is limited application of SLR technique used in conducting information privacy research domain [5], [13], [14], this study attempts to use SLR to investigate the current state of the art of information privacy concerns in healthcare environment.”
Method
Electronic records management systems and the competency of educational institutions: Evidence from Yemen
Mukred, M., Yusof, Z. M., Ahmed, W. A., Mokhtar, U. A., & Hawash, B. (2021) · Information Development · doi:10.1177/0266666920980829 · Cited by 44
“Previous studies have demonstrated the influence of security on behavior intentions (Chhanabhai and Holt, 2007; Daglish and Archer, 2009; Eze Asogwa, 2013; Adu and Ngulube, 2017; Fernández-Alemán et al., 2013).”
Result
Lessons Learned From Google Glass
Yu, J. C., Ferniany, W., Guthrie, B. L., Parekh, S. G., & Ponce, B. A. (2015) · Surgical Innovation · doi:10.1177/1553350615597085 · Cited by 32
“Though Google Glass does open a potential portal through which PHI can be lost, the device can be safely incorporated into existing electronic security infrastructure that has been developed in hospitals for the transition to electronic medical records with many using encrypted data, firewalls, antivirus, and intrusio…”
Background
A national standards-based assessment on functionality of electronic medical records systems used in Kenyan public-Sector health facilities
Kang'a, S. G., Puttkammer, N. H., Wanyee, S., Kimanga, D. O., Madrano, J., Muthee, V., Odawo, P., Sharma, A., Oluoch, T., Robinson, K. M., et al. (2016) · International Journal of Medical Informatics · doi:10.1016/j.ijmedinf.2016.09.013 · Cited by 30
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“[11] conducted a systematic literature review concerning the security and privacy of electronic health record (EHR) systems.”
Restrictions on Nursing Students' Electronic Health Information Access
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“It is the responsibility of the health care organization's privacy or compliance officer to determineelectronicrecords'securityaccess levelbasedonhealth careworkerrole,provideadequate training, followsecurity authorization procedures, andmonitor user activity.(10) It is equally important forhealthcare informationusers…”
Background
Towards privacy compliance: A design science study in a small organization
Li, Z. S., Werner, C., Ernst, N., & Damian, D. (2022) · Information and Software Technology · doi:10.1016/j.infsof.2022.106868 · Cited by 30
“Furthermore, similar to our collaborating organization, a sizable contingent of the articles in the study mention the use of pseudo-anonymization [24].”
Background
The Effects of the Use of Patient-Accessible Electronic Health Record Portals on Cancer Survivors’ Health Outcomes: Cross-sectional Survey Study
Liu, P. L., Zhao, X., & Ye, J. F. (2022) · Journal of Medical Internet Research · doi:10.2196/39614 · Cited by 30
“…by facilitating access to patient information (eg, test results) [8], allowing timely and efficient patient-provider communication [9], reducing medical errors [10], educating patients with accessible and affordable health materials [11], and enhancing the privacy and security of patient data [12].”
Health Information Security in Hospitals: the Application of Security Safeguards
Mehraeen, E., Ayatollahi, H., & Ahmadi, M. (2016) · Acta Informatica Medica · doi:10.5455/aim.2016.24.47-50 · Cited by 30
The Risks to Patient Privacy from Publishing Data from Clinical Anesthesia Studies
O’Neill, L., Dexter, F., & Zhang, N. (2016) · Anesthesia & Analgesia · doi:10.1213/ane.0000000000001331 · Cited by 30
Recommender-based privacy requirements elicitation - EPICUREAN
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“Yet, a review of current electronic health record systems shows that these systems do not provide appropriate data protection measures [12].”
Background
Software vulnerabilities overview: A descriptive study
Sánchez, M. C., de Gea, J. M. C., Fernández‐Alemán, J. L., Garceran, J., & Toval, A. (2019) · Tsinghua Science & Technology · doi:10.26599/tst.2019.9010003 · Cited by 29
“Security problems due to software vulnerabilities can become particularly worrisome in the case of compromising information of a private nature, such as, for example, information related to a patient’s health history [8–10] .”
BackgroundSelf-citation
Threats to patients’ privacy in smart healthcare environment
Ahmed, S. M., & Rajput, A. (2019) · Elsevier eBooks · doi:10.1016/b978-0-12-819043-2.00016-2 · Cited by 28
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Yang, X., Mu, D., Peng, H., Li, H., Wang, Y., Wang, P., Wang, Y., & Han, S. (2022) · JMIR Medical Informatics · doi:10.2196/33799 · Cited by 29
“Recently, several systematic reviews related to EHRs have been published, with particular attention given to the implementation of EHR systems [47,48].”
Background
A Systematic Investigation on Barriers and Critical Success Factors for Clinical Information Systems in Integrated Care Settings
Schweitzer, M., & Hoerbst, A. (2015) · Yearbook of Medical Informatics · doi:10.15265/iy-2015-018 · Cited by 29
“Encryption [47], comprehensive logging [48] and user education [47] are regarded as important measures in this context.”
Background
Enhancing Privacy Controls for Patients via a Selective Authentic Electronic Health Record Exchange Service: Qualitative Study of Perspectives by Medical Professionals and Patients
Alaqra, A. S., Fischer‐Hübner, S., & Framner, E. (2018) · Journal of Medical Internet Research · doi:10.2196/10954 · Cited by 29
“Related work has focused on technical means for addressing privacy and security challenges in EHR systems [34-36].”
eHealth in Egypt: The demand-side perspective of implementing electronic health records
Badran, M. F. (2019) · Telecommunications Policy · doi:10.1016/j.telpol.2019.01.003 · Cited by 29
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Bachiri, M., Idri, A., Fernández-Alemán, J. L., & Toval, A. (2018) · Journal of Medical Systems · doi:10.1007/s10916-018-1002-x · Cited by 36
Self-citation
Security in cloud computing: A mapping study
Cruz, Z., Fernández‐Alemán, J. L., & Toval, A. (2014) · Computer Science and Information Systems · doi:10.2298/csis140205086c · Cited by 28
Self-citation
Health digital state and Smart EHR systems
Şerbǎnaţi, L. D. (2020) · Informatics in Medicine Unlocked · doi:10.1016/j.imu.2020.100494 · Cited by 28
Security of electronic personal health information in a public hospital in South Africa
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The relationship between e-health literacy and information technology acceptance, and the willingness to share personal and health information among pregnant women
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Lyon, A. R., Lewis, C. C., Melvin, A., Boyd, M. R., Nicodimos, S., Liu, F. F., & Jungbluth, N. J. (2015) · Implementation Science · doi:10.1186/s13012-016-0495-2 · Cited by 28
“…on electronic health records and other HIT led to the inclusion of additional characteristics, such as the existence of “ patient portals ” as well as characteristics such as whether the systems were compliant with the US Health Insurance Portability and Accountability Act (HIPAA) [53 – 55].”
Background
Applications of data hiding techniques in medical and healthcare systems: a survey
Sajedi, H. (2018) · Network Modeling Analysis in Health Informatics and Bioinformatics · doi:10.1007/s13721-018-0169-x · Cited by 28
Understanding eHealth Literacy From a Privacy Perspective: eHealth Literacy and Digital Privacy Skills in American Disadvantaged Communities
Li, X. (2018) · American Behavioral Scientist · doi:10.1177/0002764218787019 · Cited by 28
“Developing a secure eHealth system requires technological solutions, such as access control and data encryption, policy regulations related to information control, and education and training of all stakeholders accessing eHealth systems (Fernández-Alemán et al., 2013; Sahama et al., 2013).”
Background
Searchable Blockchain-Based Healthcare Information Exchange System to Enhance Privacy Preserving and Data Usability
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“However, owing to privacy issues and closed management systems in healthcare, there is a shortage of available EHRs [5–7].”
Background
FSSR
Huang, C., Lu, R., Zhu, H., Shao, J., & Lin, X. (2016) · ACM Asia Conference on Computer and Communications Security (ASIA CCS) · doi:10.1145/2897845.2897870 · Cited by 27
Blockchain-Based Decentralized and Secure Lightweight E-Health System for Electronic Health Records
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Designing and testing a blockchain application for patient identity management in healthcare
Khurshid, A., Holan, C. A., Cowley, C., Alexander, J., Harrell, D. T., Usman, M., Desai, I., Bautista, J. R., & Meyer, E. T. (2021) · JAMIA Open · doi:10.1093/jamiaopen/ooaa073 · Cited by 27
“At the same time, security and privacy concerns about legacy information systems and centralized electronic databases maintained by providers still persist (19, 20).”
Background
Information security and privacy in hospitals: a literature mapping and review of research gaps
Ahouanmenou, S., Looy, A. V., & Poels, G. (2022) · Informatics for Health and Social Care · doi:10.1080/17538157.2022.2049274 · Cited by 27
“Another SLR on information security and privacy in hospitals focused on electronic health records (EHRs) systems.(4) Other studies related to cybersecurity in hospitals offer cybersecurity models(5) or highlight the problem from an organizational(6) or riskmanagement angle(7) Although prior studies show interesting fi…”
Background
Information Design in An Aged Care Context
Nurgalieva, L., Frik, A., Ceschel, F., Egelman, S., & Marchese, M. (2019) · International Conference on Pervasive Computing Technologies for Healthcare · doi:10.1145/3329189.3329211 · Cited by 27
“On the other hand, extensive information disclosure and delegation of control over decisions often result in seniors’ psychological discomfort [22], as well as privacy [28] and security concerns [10].”
Background
Patients’ perception of the information security management in health centers: the role of organizational and human factors
Peikari, H. R., Ramayah, T., Shah, M. H., & Lo, M. (2018) · BMC Medical Informatics and Decision Making · doi:10.1186/s12911-018-0681-z · Cited by 42
“While the researchers in the field of computer science have explored the phenomenon of information security, most of them have studied the issue from the engineering perspective and focused on the development of technical solutions and neglected to study security from a behavioral approach [2].”
Background
Access control solutions in electronic health record systems: A systematic review
Cobrado, U. N., Sharief, S., Regahal, N. G., Zepka, E., Mamauag, M. B., & Velasco, L. C. (2024) · Informatics in Medicine Unlocked · doi:10.1016/j.imu.2024.101552 · Cited by 34
Prevalence of Sharing Access Credentials in Electronic Medical Records
Hassidim, A., Korach, T., Shreberk‐Hassidim, R., Thomaidou, E., Uzefovsky, F., Ayal, S., & Ariely, D. (2017) · Healthcare Informatics Research · doi:10.4258/hir.2017.23.3.176 · Cited by 25
“The same mechanisms that enable healthcare providers to easily access any required piece of information with ease, can also be exploited for unjustified access competitors and insiders alike [5].”
BackgroundInfluential
Controlled searching in reversibly de-identified medical imaging archives
Silva, J. M., Pinho, E., Monteiro, E., Silva, J., & Costa, C. M. A. (2017) · Journal of Biomedical Informatics · doi:10.1016/j.jbi.2017.12.002 · Cited by 25
Provably Secure Symmetric Private Information Retrieval with Quantum Cryptography
Kon, W. Y., & Lim, C. C. W. (2020) · Entropy · doi:10.3390/e23010054 · Cited by 25
“To illustrate how SPIR can be implemented on this network, we turn to the example of accessing electronic health records on a database [37].”
Method
Systematizing core properties of pairing-based attribute-based encryption to uncover remaining challenges in enforcing access control in practice
Venema, M., Alpár, G., & Hoepman, J.-H. (2022) · Designs Codes and Cryptography · doi:10.1007/s10623-022-01093-5 · Cited by 25
Toward Uniform Smart Healthcare Ecosystems: A Survey on Prospects, Security, and Privacy Considerations
Habibzadeh, H., & Soyata, T. (2019) · Springer eBooks · doi:10.1007/978-3-030-27844-1_5 · Cited by 25
Future of Pharmaceutical Industry: Role of Artificial Intelligence, Automation and Robotics
Manoj Kumar, T., Preethi, B., Nunavath, R. S., & Nagappan, K. (2024) · Journal of Pharmacology and Pharmacotherapeutics · doi:10.1177/0976500x241252295 · Cited by 24
Evaluating authentication options for mobile health applications in younger and older adults
Grindrod, K., Khan, H., Hengartner, U., Ong, S. W., Logan, A. G., Vogel, D., Gebotys, R. J., & Yang, J. (2018) · PLoS ONE · doi:10.1371/journal.pone.0189048 · Cited by 24
The basics of data, big data, and machine learning in clinical practice
Valdez, D. A. S., Peláez-Ballestas, I. D. P., de Lara, A. M., & Gastelum‐Strozzi, A. (2020) · Clinical Rheumatology · doi:10.1007/s10067-020-05196-z · Cited by 26
An Ontology for Privacy Requirements via a Systematic Literature Review
Gharib, M., Giorgini, P., & Mylopoulos, J. (2020) · Journal on Data Semantics · doi:10.1007/s13740-020-00116-5 · Cited by 24
Information Security Behavior in Health Information Systems: A Review of Research Trends and Antecedent Factors
Sari, P. K., Handayani, P. W., Hidayanto, A. N., Yazid, S., & Aji, R. F. (2022) · Healthcare · doi:10.3390/healthcare10122531 · Cited by 24
“PRISMA has been used in previous studies in the field of information systems primarily related to health services, such as user acceptance of hospital information systems [55], security and privacy in electronic health records [38,39], and information security culture in general [44].”
BackgroundMethod
Patient-Controlled Attribute-Based Encryption for Secure Electronic Health Records System
Eom, J., Lee, D. H., & Lee, K. (2016) · Journal of Medical Systems · doi:10.1007/s10916-016-0621-3 · Cited by 26
“As paper-based medical charts have been transformed into digital versions of health information, possible security and privacy issues are highlighted in storing this biomedical information on cloud [3, 6, 10, 29].”
Background
Privacy and security of electronic patient records – Tailoring multimethodology to explore the socio-political problems associated with Role Based Access Control systems
Small, A., & Wainwright, D. W. (2017) · European Journal of Operational Research · doi:10.1016/j.ejor.2017.07.041 · Cited by 24
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Authors: Fernández-Alemán, J. L., Señor, I. C., Lozoya, P. Á. O., & Toval, A.
Affiliations: Universidad de Murcia (ES)
Corresponding author: Señor, Inmaculada Carrión
ORCID: Toval, Ambrosio
Venue: Journal of Biomedical Informatics
Publisher: Elsevier BV
Published: 2013-06
Volume: 46
Issue: 3
Pages: 541-562
ISSN: 1532-0464 (ISSN-L)
DOI: 10.1016/j.jbi.2012.12.003
OpenAlex: W2128232860
Cited by: 675
References: 127
Citations by year: 2026: 23 · 2025: 39 · 2024: 72 · 2023: 59 · 2022: 46 · 2021: 59 · 2020: 57 · 2019: 82 · 2018: 57 · 2017: 48 · 2016: 56 · 2015: 38 · 2014: 29 · 2013: 10
FWCI: 7.79
Type: journal article
Language: en
Open access: bronze
doi.org
Licence: www.elsevier.com/tdm/userlicense/1.0/ (tdm)
www.elsevier.com/open-access/userlicense/1.0/ (vor, 365 d)
Locations: Journal of Biomedical Informatics (publishedVersion)
PubMed (publishedVersion)
Funders: Spanish Ministry of Science and Technology (TIN2009-13718-C02-01, TIN2009-13718-C02-02)
Topics: Health Sciences › Health Professions › Health Information Management › Electronic Health Records Systems
Physical Sciences › Computer Science › Computer Networks and Communications › Access Control and Trust
Health Sciences › Health Professions › Health Information Management › Thoreau and American Literature
Keywords: electronic health records, health information security, privacy, HIPAA, Data Protection Directive 95/46/EC, public key infrastructure, digital signatures, pseudo-anonymity, role-based access control, access control, audit logging, user authentication
MeSH terms: Europe, United States, Computer Security, Privacy, Health Insurance Portability and Accountability Act, Electronic Health Records

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