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The HIPAAcratic oath: do no harm to patient data.

Physician executives need to prepare their organizations for the next great system-wide challenge--HIPAA, the Health Insurance Portability and Accountability Act of 1996. Organizations will have to plan for and execute a compliance program with the same vigor and system-wide participation as they did for Y2K. This article provides a brief overview of HIPAA, emphasizing the privacy and security components that will be the biggest challenge for physician executives. Physician leaders must become actively involved in the policymaking process to ensure a balanced approach to protecting the confidentiality of health information, while giving providers optimal access to data to make informed decisions on patient care and management. Ignoring HIPAA is simply not an option.

Computer Security↗

'Second generation' Internet e-health: the gladiator for HIPAA compliance?

The Health Insurance Portability and Accountability Act (HIPAA) is intended to simplify administrative processes and improve health information security. There are a number of traditional ways to address the expense and complexities of simplification, but none of them are bargains or beauties to behold: (1) Do-it-yourself encryption; (2) new back-end system purchases; (3) legacy system re-programming; or (4) onerous paper documentation. The good news is that 'second generation' e-health solutions are emerging that act as internal "wrappers" for health plan or provider data systems. They provide both an interface for end-users and a layer of security for organizational information and allow detailed patient-related data to remain at the system owner's physical location. These second generation solutions don't just 'connect,' data, they actually 'understand' the information, and can use data elements to invoke necessary rules, processing pathways, or personalization for specific stakeholders as required by HIPAA.

Computer Security↗

Network information security in a phase III Integrated Academic Information Management System (IAIMS).

The developing Integrated Academic Information System (IAIMS) at Columbia-Presbyterian Medical Center provides data sharing links between two separate corporate entities, namely Columbia University Medical School and The Presbyterian Hospital, using a network-based architecture. Multiple database servers with heterogeneous user authentication protocols are linked to this network. "One-stop information shopping" implies one log-on procedure per session, not separate log-on and log-off procedures for each server or application used during a session. These circumstances provide challenges at the policy and technical levels to data security at the network level and insuring smooth information access for end users of these network-based services. Five activities being conducted as part of our security project are described: (1) policy development; (2) an authentication server for the network; (3) Kerberos as a tool for providing mutual authentication, encryption, and time stamping of authentication messages; (4) a prototype interface using Kerberos services to authenticate users accessing a network database server; and (5) a Kerberized electronic signature.

Computer Communication Networks↗

Swedish experience in secure health telematics applications.

In the paper, some common questions and parallel development of ICT for eGovernment and eHealth in Sweden are discussed. In that context, front office and back office are two areas of information security development. Furthermore, information will be provided on "Catch 22" getting means for eIdentification and eSignature out to a large part of the population. Thereby, the catch of how to use a Government procurement of eIdentification and eSignature must be solved. The paper evaluates the lessons learned and current situation in Sweden for eServices, certificates and smart cards.

Computer Security↗

RESHEN, a best practice approach for secure healthcare networks in Europe.

Electronic communication of healthcare related information (in the framework of Regional Healthcare Information Networks), introduces a number of security risks with regard to confidentiality, integrity and availability, which can become quite crucial taking into account its sensitive nature. Public Key Infrastructure (PKI) is acknowledged as an appropriate means for dealing with such risks, as long as all the involved critical factors are first practically assessed. This paper presents a best-practice approach for secure regional healthcare networks in Europe, examining all the identified crucial parameters (technical, organisational, legal/regulatory, medical and business). Our approach is conducted at two levels (the regional and the European), including the integration of PKI-aware security mechanisms (strong authentication, encryption, digital signature, time-stamping) in three regional pilot sites in Greece, Finland and Germany and demonstrating their interconnection in a pan-European architecture. Following the above approach, some major conclusions are excluded, pointing out existing open issues and possible steps forward.

Access to Information↗

An integrated data-warehouse-concept for clinical and biological information.

The development of medical research networks within the framework of translational research has fostered interest in the integration of clinical and biological research data in a common database. The building of one single database integrating clinical data and biological research data requires a concept which enables scientists to retrieve information and to connect known facts to new findings. Clinical parameters are collected by a Patient Data Management System and viewed in a database which also includes genomic data. This database is designed as an Entity Attribute Value model, which implicates the development of a data warehouse concept. For the realization of this project, various requirements have to be taken into account which has to be fulfilled sufficiently in order to align with international standards. Data security and protection of data privacy are most important parts of the data warehouse concept. It has to be clear how patient pseudonymization has to be carried out in order to be within the scope of data security law. To be able to evaluate the data stored in a database consisting of clinical data collected by a Patient Data Management System and genomic research data easily, a data warehouse concept based on an Entity Attribute Value datamodel has been developed.

Computer Security↗

Architecture of authorization mechanism for medical data sharing on the grid.

Data security is becoming increasingly important as the Grid matures. The advances of the Grid have allowed scientists and researchers to build a data grid where they can share and exchange research-related data and information. In reality, however, these specialists do not benefit enough from this data grid. The reason is that the current Grid does not have sufficiently robust and flexible data security. We investigate a medical data-sharing environment where medical doctors and scientists can securely share clinical and medical research data. We show medical data sharing that takes advantage of PERMIS, or an RBAC-based authorization system that achieves XML element level access control. We also describe the lessons learnt in designing the environment as well as a comparison with other existing authorization mechanisms.

Computer Security↗

The public health information infrastructure. A national review of the law on health information privacy.

Our objectives were to review and analyze the laws in the 50 states, the District of Columbia, and Puerto Rico that regulate the acquisition, storage, and use of public health data and to offer proposals for reform of the laws on public health information privacy. Virtually all states reported some statutory protection for governmentally maintained health data for public health information in general (49 states), communicable diseases (42 states), and sexually transmitted diseases (43 states). State statutes permitted disclosure of data for statistical purposes (42 states), contact tracing (39 states), epidemiologic investigations (22 states), and subpoena or court order (14 states). The survey revealed significant problems that affect both the development of fair and effective public health information systems and the protection of privacy. Statutes may be silent about the degree of privacy protection afforded, confer weaker privacy protection to certain kinds of information, or grant health officials broad discretion to disseminate personal information. Our proposals for law reform are based on a meeting of experts at the Carter Presidential Center under the auspices of the Centers for Disease Control and Prevention and the Council of State and Territorial Epidemiologists: (1) an independent data protection commission should be established, (2) health authorities should justify the collection of personally identifiable information, (3) subjects should be given basic information about data practices, (4) data should be held and used in accordance with fair information practices, (5) legally binding privacy and security assurances should attach to identifiable health information with significant penalties for breach of these assurances, (6) disclosure of data should be made only for purposes consistent with the original collection, and (7) secondary uses beyond those originally intended by the data collector should be permitted only with informed consent.

Computer Security↗

WWW-based access to object-oriented clinical databases: the KHOSPAD project.

KHOSPAD is a project aiming at improving the quality of the process of patient care concerning general practitioner-patient-hospital relationships, using current information and networking technologies. The studied application field is a cardiology division, with hemodynamic laboratory and the population of PTCA patients. Data related to PTCA patients are managed by ARCADIA, an object-oriented database management system developed for the considered clinical setting. We defined a remotely accessible view of ARCADIA medical record, suitable for general practitioners (GPs) caring patients after PTCA, during the follow-up period. Using a PC, a modem and Internet, an authorized GP can consult remotely the medical records of his PTCA patients. Main features of the application are related to the management and display of complex data, specifically characterized by multimedia and temporal features, based on an object-oriented temporal data model.

Angioplasty, Balloon, Coronary↗

A new twist in US health care data standards development: adoption of electronic health care transactions standards for administrative simplification.

To reduce the costs of common administrative transactions, health plans, payers and providers encouraged the US Congress to legislate administrative simplification of specific electronic health data transactions. The Health Insurance Portability and Accountability Act (HIPAA) of 1996 created incentives for a public-private partnership to develop and implement standards for the uniformity of health care data used in electronic administrative health transactions and standards for the privacy and security of individually identifiable health information. The standards' requirements of HIPAA and how they have been met by the US government hold promise for accelerating the uniform adoption of standards developed by accredited standards developing organizations. The transactions designated by Congress, the process of choosing the standards in the Department of Health and Human Services, the principles that guided these choices, and the actual choices, are presented here. A successful partnership for administrative health data standards can pave the way for success in clinical health data standards and their application in computer-based patient record systems.

Computer Security↗

Community health information networks. Threat or opportunity in the doctor-patient relationship?

The last half of the 20th Century has been witness to numerous changes in the delivery and financing of health care services. These changes have impacted the one-to-one doctor-patient relationship that may have existed in the past to become a complex of relationships. The contemporary physician collaborates with many other professionals to assist in the delivery, financing, and monitoring of health care services. These clinicians and other professionals require access to patient information to deliver care and secure payment. The patient understands this. Yet the patient has concerns about the widening circle of persons authorized to access his or her information. These concerns have been amplified by the development of community health information networks--(CHINs). This article focuses on CHINs, both patient concerns and the role physicians can take in developing them.

Community Networks↗

[The personal data act, clinical trials and data privacy. Rules for treatment of personal data in clinical trials and scientific research projects].

The Danish Act on Processing of Personal Data applies to all processing of data for the purpose of carrying out medical trials and other scientific or statistical studies. Prior to the commencement of the processing of data, a private controller, i.e. a pharmaceutical company, shall notify the Danish Data Protection Agency and obtain the authorisation of the Agency. The article presents the various conditions laid down by the Agency for the carrying out of the processing operations. Furthermore, special attention is drawn to the data subject's various rights. In order to ensure the privacy of the data subject and to protect data against accidental or unlawful destruction, loss or alteration and against unauthorized disclosure, the controller shall implement certain technical and organisational security measures laid down by the Agency. When a controller leaves the processing of data to a processor, the processor is obliged to ensure compliance with the given measures. The Data Protection Agency supervises that the processing is carried out in compliance with the provisions of the Act and the conditions laid down by the Agency.

Clinical Trials as Topic↗

Open Source in the European Union: a future way for health applications?

Since 1999, the Open Source movement has aroused the interests of different players of the Information Society. M. E. Liikanen, European Commissioner for Enterprise and Information Society, has publicly expressed an interest for more security through the use of Open Source software. Municipalities deployed desktops and servers based on Open Source software in Spain, France, Austria and Belgium. Some health professionals see in this movement a way of obtaining better software, more secure and interoperable. This presentation explores the context and economical considerations at the basis of the Open Source movement, its rationale in a research programme publicly financed and some of the challenges ahead. It concludes on the observations that Open Source is high on several agendas but needs to quickly become an economical activity to deliver its promises.

Computer Security↗

Security infrastructure requirements for electronic health cards communication.

Communication and co-operation processes in the healthcare and welfare domain require a security infrastructure based on services describing status and relation of communicating principals as well as corresponding keys and attributes. Additional services provide trustworthy information on dynamic issues of communication and co-operation such as time and location of processes, workflow relations, integrity of archives and record systems, and system behaviour. To provide this communication and co-operation in a shared care environment, smart cards are widely used. Serving as storage media and portable application systems, patient data cards enable patient-controlled exchange and use of personal health data bound to specific purposes such as prescription and disease management. Additionally, patient status data such as the emergency data set or immunization may be stored in, and communicated by, patient data cards. Another deployment field of smart cards is their token functionality within a security framework, supporting basic security services such as identification, authentication, integrity, confidentiality, or accountability using cryptographic algorithms. In that context, keys, certificates, and card holder's attributes might be stored in the card as well. As an example, the German activity of introducing patient health cards and health professional cards is presented. Specification and enrolment aspects are on-going processes.

Communication↗

The German teleradiology system MEDICUS: system description and experiences in a German field test.

MEDICUS is a teleradiology system which has been developed in a joint project of the German Cancer Research Center (Deutsches Krebsforschungszentrum) and the Transfer Center Medical Informatics (Steinbeis-Transferzentrum Medizinische Informatik) in Heidelberg, Germany. The system is designed to work on ISDN lines as well as in a local area network. Special attention has been given to the design of the user interface and data security, integrity, and authentication. The software is in use in 13 radiology departments in university clinics, small hospitals, private practices, and research institutes. More than 25 thousand images have been processed in 6 months. The system is in use in six different application scenarios. MEDICUS is running under the UNIX operating system. The connection of the modalities could in most cases not be realized with the DICOM protocol as older machines were not equipped with this standard protocol. Clinical experiences show that the MEDICUS system provides a very high degree of functionality. The system has an efficient and user friendly graphical user interface. The result of a comparison with other systems shows that MEDICUS is currently the best known teleradiology system. Cost reductions are already obvious, but additional research has to be performed in this field. An even more powerful commercial successor is currently under construction at the Steinbeis-Transferzentrum Medizinische Informatik in Heidelberg.

Ambulatory Care Facilities↗

The legal and risk management conundrum of telemedicine.

A store-and-forward teledermatology service was established between two general practices and the department of plastic surgery at Derriford Hospital in Plymouth. An academic lawyer and an expert in risk management made an assessment of the service. They looked at the following issues: medicolegal problems; security; confidentiality; and risk. None of them was considered insoluble and there is no reason why such issues should prevent the National Health Service from developing telemedicine services. All organizations considering telemedicine need to ensure that the proposed telemedicine service satisfies the issues raised in this study.

Computer Security↗

Potential impacts of patient access to their electronic care records.

This paper examines the interest and expectations of patients having access to their electronic care records. Semi-structured prospective interviews were performed with 109 patients in a community setting in London where all records are stored digitally either as coded data, free text or scanned in from the paper original. A booth had recently been set up for patients to access their electronic records in the waiting room with secure access through fingerprint recognition technology. The interviews detailed history and levels of interest in access, impact on relationship with clinician, familiarity with digital media and issues of security and accuracy. Patients were more interested in seeing their electronic than their paper record; they felt it would improve their relationship with their clinician; they generally trusted in the security of their records; they anticipated that there would be some mistakes; they were enthusiastic about the idea of adding to the record themselves, but were divided about having access over the internet. Patients are confident in and anticipate the value of having access to their electronic records.

Adolescent↗

Enhancing security and improving interoperability in healthcare information systems.

Security is a key issue in healthcare information systems, since most aspects of security become of considerable or even critical importance when handling healthcare information. In addition, the intense need for information exchange has revealed interoperability of systems and applications as another key issue. Standardization can play an important role towards both these issues. In this paper, relevant standardization activities are briefly presented, and existing and emerging healthcare information security standards are identified and critically analysed. The analysis is based on a framework which has been developed for this reason. Therefore, the identification of gaps and inconsistencies in current standardization, the description of the conflicts of standards with legislation, and the analysis of implications of these standards to user organizations, are the main results of this paper.

Algorithms↗