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PubMed1996

Telemedicine and security. Confidentiality, integrity, and availability: a Canadian perspective.

The health care system is undergoing major reform, characterized by organized delivery systems (regionalization, decentralization, devolution, etc); shifts in care delivery sites; changing health provider roles; increasing consumer responsibilities; and accountability. Rapid advances in information technology and telecommunications have led to a new type of information infrastructure which can play a major role in this reform. Compatible health information systems are now being integrated and connected across institutional, regional, and sectorial boundaries. In the near future, these information systems will readily be accessed and shared by health providers, researchers, policy makers, health consumers, and the public. SECURITY is a critical characteristic of any health information system. This paper will address three fields associated with SECURITY: confidentiality, integrity, and availability. These will be defined and examined as they relate to specific aspects of Telemedicine, such as electronic integrated records and clinical databases; electronic transfer of documents; as well as data storage and disposal. The guiding principles, standards, and safeguards being considered and put in place to ensure that telemedicine information intrastructures can protect and benefit all stakeholders' rights and needs in both primary and secondary uses of information will be reviewed. Implemented, proposed, and tested institutional, System, and Network solutions will be discussed; for example, encryption-decryption methods; data transfer standards; individual and terminal access and entry I.D. and password levels; smart card access and PIN number control; data loss prevention strategies; interference alerts; information access keys; algorithm safeguards; and active marketing to users of standards and principles. Issues such as policy, implementation, and ownership will be addressed.

Canada↗

PubMed2004

Security of health care records in Belgium. Application in a University Hospital.

Access rules to electronic patient records (EPR) have been issued by the Belgian Council of Physicians. Access to identifiable data of the EPR is restricted to anyone responsible for diagnosis, treatment and continuity of care of the patient. By delegation, associated personnel, like secretaries, can also be authorised to have access. A new perspective is given by the availability in 2003 of a national identification card allowing electronic signature of patients. It could not only authorise but also forbid some accesses. A law in 2002 gives right to patients to access to their own record. Health personnel can also be identified by cards but the system is not yet implemented. In the meantime, local measures have been made. We describe practical solutions that have been taken as priorities in a University Hospital. It was felt more important to allow access to lifesaving EPR data than to restrict its access by too strictly theoretical rules. A pilot study (S3 project) is also in progress for interinstitutional communication in Belgium, using the unique identification number of the patient and a "third server".

Belgium↗

PubMedDate not supplied

The new informatics of national healthcare reform.

The President's Health Security Act has succeeded in attracting America's attention. Several of its initiatives have been well-publicized and hotly debated in Congress. The act also includes a number of implications for healthcare informatics, and devotes an entire chapter to this subject, although this area has not received as much publicity. Every behavioral healthcare provider's information system would be significantly affected by enactment of the Health Security Act. Selected forms and data elements for the management and delivery of behavioral healthcare services would need to be standardized. Organizations of behavioral healthcare providers, managed care companies and purchasers would increasingly share selected patient and subscriber information in aggregated form, for a variety of purposes. As a result, tougher laws to protect patient data privacy will likely be forthcoming. The following article gives an overview of the informatics needs of the soon-to-be reformed American healthcare system, into which behavioral healthcare will be integrated. As part of the larger system, behavioral healthcare services and information systems will need to comply with the same guidelines and requirements, outlined below, as other healthcare providers. Preparation to meet the information demands of the evolving healthcare system will require adaptation of existing computerized information systems, utilization of new technology, consultation with the system's major shareholders and attention to continuous quality improvement processes.

Computer Communication Networks↗

PubMed2002

Networking in shared care--first steps towards a shared electronic patient record for cancer patients.

OBJECTIVES: This paper aims at identifying the data protection and security requirements for a cross-institutional EPR. Three possible models and the first steps towards a cross-institutional EPR for the Thoraxklinik Heidelberg and the Department of Clinical Radiology of the University Medical Center of Heidelberg shall be discussed. METHODS: A comprehensive analysis of literature and legal documents supplied information for determining the data protection and security requirements. By means of information system analysis, the technical preconditions in both institutions as well as three possible models towards a cross-institutional EPR were identified. RESULTS: According to the German penal code it is only allowed to reveal patient information to external physicians in cases of so-called "treatment connection". An extension of the written consent, signed by the patient, verifying the patient agreement that his/her patient data will be stored in a cross-institutional EPR is needed. Among the three models that we identified, the model that constitutes of a virtual EPR with distributed data capture in both institutions was favored. By means of SecuRemote software a secure connection between the Thoraxklinik Heidelberg and the Department of Clinical Radiology was established, allowing the physicians to view the complete cross-institutional health information of a jointly treated patient during the weekly consultation on radiotherapy. CONCLUSIONS: Many requirements listed in this paper are requirements for electronic patient records in general. Besides these general requirements there are specific requirements for a cross-institutional EPR. The legal situation in Germany complicates the development and implementation of a cross-institutional EPR. However, we think that the efforts are reasonable, because a cross-institutional EPR will be able to improve the communication between health institutions, medical disciplines and persons involved in shared care processes. It provides them with more complete health information about the jointly treated patients. A cross-institutional EPR is, therefore, expected to improve the quality of patient care.

Ambulatory Care Facilities↗

PubMed2004

Security issues arising in establishing a regional health information infrastructure.

A regional health information infrastructure is being developed in an internally self-governing country which is a dependent territory of the British Crown, is not part of the United Kingdom but is a member of the British Commonwealth. This country of about 70000 inhabitants (and significant numbers of visitors) within the British Isles shares many functions with the United Kingdom-from the perspective of this paper the key shared functions relate to the infrastructure of the departments of social security, social services, central registry, all health care services and national insurance systems. Although it remains independent in various other respects, for the most part it endeavours to achieve an harmonious legislative relationship with the UK, and with the EU. One primary goal of the information infrastructure development project is to provide links between community, primary and secondary healthcare services and thereby to ensure integrity of information as it refers to each individual receiving care services. A second goal has been to integrate this environment with various other government functions including the issuing and checking of NHS ID numbers and of national insurance ID numbers, the payment of social welfare benefits, and perhaps with other functions where access to a common list of names and addresses is a significant factor. This paper outlines some of the issues that have arisen in endeavouring to meet the often conflicting wishes and needs of different groups as regards a health information infrastructure within a general public sector information service.

Computer Security↗

PubMed2026

NoisyFlow: differentially private optimal transport using neural networks for secure biomedical data sharing across multiple institutions.

MOTIVATION: Biomedical models improve when trained on data pooled across institutions, but sensitive patient records (e.g. genomics, clinical data, and medical images) are difficult to share due to privacy constraints. Moreover, data collected at different sites often have shifted distributions because of covariate differences (including batch effects), so privacy-preserving sharing alone cannot simply resolve cross-site mismatch. Methods that protect individuals while explicitly aligning distributions are needed to enable reliable multi-institutional analyses. RESULTS: We present NoisyFlow, a three-stage differentially private framework for cross-institutional harmonization under distribution shift. In stage I, each site learns a differentially private flow-based generator of its local labeled distribution. In stage II, it learns a neural optimal transport map to a shared reference distribution. In stage III, a central server composes the released models to generate reference-aligned pseudo-data for downstream analysis without accessing raw records. Across four biomedical settings spanning single-cell genomics, histopathology, neurogenomics, and wearable sensing, NoisyFlow reduces distribution shift while preserving downstream utility under formal differential privacy guarantees. AVAILABILITY AND IMPLEMENTATION: The implementation of NoisyFlow is available at https://github.com/gersteinlab/NoisyFlow.

Information Dissemination↗

PubMed2006

Web-based Internet telemedicine management of patients with heart failure.

An Internet-based store-and-retrieval telemedicine system to communicate between patients and their healthcare provider was tested. The system requires no specialized equipment, is Web-based, and allows frequent surveillance of the health status of the patients with heart failure (HF). Thirty six patients were recruited to evaluate a Web-based telemedicine system for reducing care encounters. Eighteen patients were randomized to the telemedicine arm (group T), and 18 were given usual clinical care (group C) in our HF center. Patients in group T reported three times weekly via a secure Internet site for telemedicine intervention. We studied patients with HF with New York Heart Association (NYHA) class 2 to 4 with hospitalization within past 6 months. Mean age was 56.1 +/- 12.6 years (66.7% male; 66.7% Caucasian, 27.8% African American, and 5.6% Hispanic). Mean ejection fraction (EF) was 23.9% +/- 17.6% in group T and 26.6% +/- 16.4% in group C. Over an 8-month period, unscheduled (group T-3; group C-5), and scheduled clinic visits (group T-11, group C-7) were similar (p = NS); one group T patient was transplanted, one group C patient died. Total hospital days were lower with group T (44 days) compared to group C (133 days), p < 0.05. An Internet-based telemedicine system was able to closely monitor patients with HF. Surveillance through Internet-based telemedicine resulted in less hospitalization compared to control patients. This system may be helpful in reducing the cost of HF patient care.

Computer Security↗

PubMed2005

Standardization of teleradiology using Dicom e-mail: recommendations of the German Radiology Society.

Until recently there has been no standard for an interoperable and manufacturer-independent protocol for secure teleradiology connections. This was one of the main reasons for the limited use of teleradiology in Germany. Various teleradiology solutions have been developed in the past, but the vast majority have not been interoperable. Therefore an ad hoc teleradiology connection was impossible even between partners who were already equipped with teleradiology workstations. Based on the evaluation of vendor-independent protocols in recent years the IT Working Group (AGIT) of the German Radiology Society set up an initiative to standardize basic teleradiology. An e-mail based solution using the Dicom standard for e-mail attachments with additional encryption according to the OpenPGP standard was found to be the common denominator. This protocol is easy to implement and safe for personalized patient data and fulfills the legal requirements for teleradiology in Germany and other countries. The first version of the recommendation was presented at the 85th German Radiology Convention in 2004. Eight commercial and three open-source implementations of the protocol are currently available; the protocol is in daily use in over 50 hospitals and institutions.

Computer Communication Networks↗

PubMed2006

BioHealth--the need for security and identity management standards in eHealth.

The experience gained in these last years and the several lesson learned have clearly shown that eHealth is more than just a simple change from paper records to electronic records. It necessitates a change of paradigms, on the one hand and the use of new technologies and introduction of new procedures on the other. Interoperability becomes a crucial issue. Security and confidentiality are vital for the acceptance of the new approaches and for the support of eHealth. Shared care and across-border interactions require a reliable and stable normative framework based on the application of standardized solutions, which are often not yet sufficiently known, diffused and implemented. Feeling this gap, a group of international experts in the medical area proposed to the EC the BioHealth project whose main aim is to create awareness about standardization in eHealth and to facilitate its practical implementation. The project will address all the stakeholders concerning their respective domain. It will evaluate the socio-economic and cultural aspects concerning eHealth with particular reference to the growing introduction of emerging technologies such as health cards, biometrics, RFID (radio-frequency identification) and NFC (Near field communication) tags. By providing information and expert advice on standardization and best practices it will raise the acceptance on standardization. Furthermore, the project will deeply approach the ethical and accessibility issues connected to identity management in eHealth, which -together with privacy- represent probably the most significant obstacles for the wide diffusion of eHealth procedures.

Biometry↗

PubMed2004

Access and authorisation in a Glocal e-Health Policy context.

Challenges to the development of appropriate yet adaptable policy and tools for security of the individual patient electronic health record (EHR) are proving to be significant. Compounding this is the unique capability of e-health to transgress all existing geo-political and other barriers. Initiatives to develop and advance policy, standards, and tools in relation to EHR access control and authorisation management must address this capability. Currently policy development initiatives take place largely in an isolated manner. This jeopardises the potential of e-health because decisions made in one jurisdiction might hamper, even prevent, an e-health opportunity in another. This paper places access and authorisation issues in an overall policy context through describing current Canadian initiatives. The National Initiative for Telehealth (NIFTE) Guidelines project is developing a framework of national guidelines for telehealth. The Policy and Peer Permission (PPP) project is developing a unique tool that provides persistent protection of data. The new corporate body 'Infoway' is developing a pan-Canadian electronic health record solution. Finally, the Glocal e-Health Policy initiative is developing a tool with which to identify and describe the inter-relationships of e-health issues amongst policy levels, themes, and actors.

Access to Information↗

PubMed2003

Data security and protection in cross-institutional electronic patient records.

This paper aims at identifying the specific legal requirements concerning data security and data protection of patient health data that apply to a cross-institutional electronic patient record (EPR) and describes possible solutions for meeting these requirements. In Germany, the legal framework for such records provide that disclosure of patient health information to physicians of third-party institutions is only allowed in case that it is necessary for the joint treatment of the patient, i.e. in case of a "treatment connection". As a first step, the functionality of a remote-access architecture was proven allowing a one-way connection between the EPR systems of two health institutions in Germany, which jointly treat tumor patients. Besides, a signature system model for ensuring the integrity and authenticity of medical documents was developed and implemented in the existing information system architecture of the University Medical Center of Heidelberg. Especially in Germany, the legal framework for cross-institutional EPRs is very complex and has a considerable influence on the development and implementation of cross-institutional EPRs. However, its introduction is thought to be valuable, since a cross-institutional EPR will improve communication within shared care processes, and thus improve the quality of patient care.

Communication↗

PubMed2006

Information governance in NHS's NPfIT: a case for policy specification.

PURPOSE: The National Health Service's (NHS's) National Programme for Information Technology (NPfIT) in the UK with its proposed nation-wide online health record service poses serious technical challenges, especially with regard to access control and patient confidentiality. The complexity of the confidentiality requirements and their constantly evolving nature (due to changes in law, guidelines and ethical consensus) make traditional technologies such as role-based access control (RBAC) unsuitable. Furthermore, a more formal approach is also needed for debating about and communicating on information governance, as natural-language descriptions of security policies are inherently ambiguous and incomplete. Our main goal is to convince the reader of the strong benefits of employing formal policy specification in nation-wide electronic health record (EHR) projects. APPROACH: Many difficulties could be alleviated by specifying the requirements in a formal authorisation policy language such as Cassandra. The language is unambiguous, declarative and machine-enforceable, and is based on distributed constrained Datalog. Cassandra is interpreted within a distributed Trust Management environment, where digital credentials are used for establishing mutual trust between strangers. RESULTS: To demonstrate how policy specification can be applied to NPfIT, we translate a fragment of natural-language NHS specification into formal Cassandra rules. In particular, we present policy rules pertaining to the management of Clinician Sealed Envelopes, the mechanism by which clinical patient data can be concealed in the nation-wide EHR service. Our case study exposes ambiguities and incompletenesses in the informal NHS documents. CONCLUSIONS: We strongly recommend the use of trust management and policy specification technology for the implementation of nation-wide EHR infrastructures. Formal policies can be used for automatically enforcing confidentiality requirements, but also for specification and communication purposes. Formalising the requirements also reveals ambiguities and missing details in the currently used informal specification documents.

Access to Information↗

PubMed2006

Long-term verifiability of the electronic healthcare records' authenticity.

PURPOSE: To investigate whether the long-term preservation of the authenticity of electronic healthcare records (EHR) is possible. To propose a mechanism that enables the secure validation of an EHR for long periods, far beyond the lifespan of a digital signature and at least as long as the lifetime of a patient. APPROACH: The study is based on the fact that although the attributes of data authenticity, i.e. integrity and origin verifiability, can be preserved by digital signatures, the necessary period for the retention of EHRs is far beyond the lifespan of a simple digital signature. It is identified that the lifespan of signed data is restricted by the validity period of the relevant keys and the digital certificates, by the future unavailability of signature-verification data, and by suppression of trust relationships. In this paper, the notarization paradigm is exploited, and a mechanism for cumulative notarization of signed EHR is proposed. RESULTS: The proposed mechanism implements a successive trust transition towards new entities, modern technologies, and refreshed data, eliminating any dependency of the relying party on ceased entities, obsolete data, or weak old technologies. The mechanism also exhibits strength against various threat scenarios. CONCLUSIONS: A future relying party will have to trust only the fresh technology and information provided by the last notary, in order to verify the authenticity of an old signed EHR. A Cumulatively Notarized Signature is strong even in the case of the compromise of a notary in the chain.

Computer Security↗

PubMed2005

A patient-identity security mechanism for electronic medical records during transit and at rest.

This paper proposes a patient-identity security mechanism, including an identity cipher/decipher and a user-authentication protocol, to ensure the confidentiality and authentication of patients' electronic medical records (EMRs) during transit and at rest. To support the confidentiality of an EMR, the identity cipher/decipher uses a data-hiding function and three logical-based functions to encrypt/decrypt a patient's identifying data and medical details in an EMR. The ciphertext of the patient's identifying data is patient-EMR related, whereas that of medical details is healthcare agent-EMR related. To support the authentication of an EMR, the user-authentication protocol based on a public key infrastructure uses certificates and dynamic cookies for verification/identification. The identity cipher has been simulated using C programming language running on a 1500 MHz Pentium PC with 512 MB of RAM. The experimental results show that healthcare agents can install large amounts of patients' encrypted EMRs in healthcare databases efficiently. In addition, separately storing the keys in a user's token and an EMR database for decryption increases the safety of patients' EMRs. For each user-authentication trail, the use of certificates and dynamic cookies for verification/identification ensures that only authorized users can obtain access to the EMR, and anyone involved cannot make false claims on the transmission made.

Computer Security↗

PubMed2001

Restructuring the electronic medical record to incorporate full digital signature capability.

The security of Electronic Medical Records can be enhanced by the addition of digital signatures that guarantee data integrity, authenticate the signer, and establish non-repudiation through the use of public key encryption. The task is complicated by the contribution of multiple providers to an encounter and the entry of data at multiple points in time Dividing encounters into an episode of care and redesigning the data model of the EMR will facilitate full signature capabilities. Generation of digital signatures is best accomplished using microprocessors on smart cards that control visibility of the private keys and assist in user authentication. The Java Programming Language including cryptography extensions and a smart card API is a useful tool for adding digital signature to an EMR. Inter-operability of signatures and continuity of signature will require attention to standards and preservation of cryptography and authentication certificate archives. Digital signatures will need to accommodate changes in data storage formats when information is transported between EMR systems using XML or other transaction standards because the original signatures will not validate if the data storage format changes. The costs of adding digital signature to EMR mandates serious examination of the business case for digital signature within an EMR as compared with transactions such as electronic prescriptions. At present, there is no regulatory requirement for digital signature of an EMR.

Computer Security↗

PubMed2006

A HIPAA-compliant architecture for securing clinical images.

The Health Insurance Portability and Accountability Act (HIPAA, instituted April 2003) Security Standards mandate health institutions to protect health information against unauthorized use or disclosure. One approach to addressing this mandate is by utilizing user access control and generating audit trails of the various authorized as well as unauthorized user access of health data. Although most current clinical image systems [e.g., picture archiving and communication system (PACS)] have components that generate log files for application debugging purposes, there is a lack of methodology to obtain and synthesize the pertinent data from the large volumes of log data generated by these multiple components within a PACS. We have designed a HIPAA-compliant architecture specifically for tracking and auditing the image workflow of clinical imaging systems such as PACS. As an initial first step, we developed HIPAA-compliant auditing system (H-CAS) based on parts of this HIPAA-compliant architecture. H-CAS was implemented within a test-bed PACS simulator located in the Image Processing and Informatics lab at the University of Southern California. Evaluation scenarios were developed where different user types performed legal and illegal access of PACS image data within each of the different components in the PACS simulator. Results were based on whether the scenarios of unauthorized access were correctly identified and documented as well as on normal operational activity. Integration and implementation pitfalls were also noted and included.

California↗

PubMed2004

Access to EHR and access control at a moment in the past: a discussion of the need and an exploration of the consequences.

The Electronic Health Record (EHR) will become a major support tool in health care delivery. This leads to heavy requirements for its quality and security. The EHR not only has to present the medical data of the patient as they are at the present time, we can anticipate that in situations of medical audit, law suits, quality control and self-assessment it may be necessary to be able to replay the EHR output as it was or would have been at a certain moment in the past. This facility could be required in order to be able to judge whether the behaviour of the health care practitioner was adequate in view of the information in the EHR as it was presented or could have been obtained from the EHR. First the need for such facility is discussed. Next the question is posed how sufficient interest for this aspect of the EHR can be raised and what role IMIA might play here. The technical consequences of the implementation of such facility are explored and they are found to be huge. The conclusion is that for a successful implementation of an EHR that (at least partly) replaces the paper record the facility is a must. However, in order to implement it, significant investments have to be made especially in development and adaptation of software. If we do not take action now the facility will not be available in time and the lack of such facility will become a road-block for EHR implementation.

Access to Information↗

PubMed2000

Security of the distributed electronic patient record: a case-based approach to identifying policy issues.

The growth of managed care and integrated delivery systems has created a new commodity, health information and the technology that it requires. Surveys by Deloitte and Touche indicate that over half of the hospitals in the US are in the process of implementing electronic patient record (EPR) systems. The National Research Council has established that industry spends as much as $15 billion on information technology (IT), an amount that is expanding by 20% per year. The importance of collecting, electronically storing, and using the information is undisputed. This information is needed by consumers to make informed choices; by physicians to provide appropriate quality clinical care: and by health plans to assess outcomes, control costs and monitor quality. The collection, storage and communication of a large variety of personal patient data, however, present a major dilemma. How can we provide the data required by the new forms of health care delivery and at the same time protect the personal privacy of patients? Recent debates concerning medical privacy legislation, software regulation, and telemedicine suggest that this dilemma will not be easily resolved. The problem is systemic and arises out of the routine use and flow of information throughout the health industry. Health care information is primarily transferred among authorized users. Not only is the information used for patient care and financial reimbursement, secondary users of the information include medical, nursing, and allied health education, research, social services, public health, regulation, litigation, and commercial purposes such as the development of new medical technology and marketing. The main threats to privacy and confidentiality arise from within the institutions that provide patient care as well as institutions that have access to patient data for secondary purposes.

Computer Security↗