Public trust and privacy in shared electronic health records

The development of information and communication technology in health care, also called eHealth, is expected to improve patient safety and facilitate more efficient use of limited resources. The introduction of electronic health records (EHRs) can make possible immediate, even automatic transfer of patient data, for health care as well as other purposes, across any kind of institutional, regional or national border. Data can thus be shared and used more effectively for quality assurance, disease surveillance, public health monitoring and research. eHealth may also facilitate patient access to health information and medical treatment, and is seen as an effective tool for patient empowerment. At the same time, eHealth solutions may jeopardize both patient safety and patients' rights, unless carefully designed and used with discretion. The success of EHR systems will depend on public trust in their compatibility with fundamental rights, such as privacy and confidentiality. Shared European EHR systems require interoperability not only with regard to technological and semantic standards, but also concerning legal, social and cultural aspects. Since the area of privacy and medical confidentiality is far from harmonized across Europe, we are faced with a diversity that will make fully shared EHR systems a considerable challenge.     

Trustworthy shared electronic health records: recordkeeping requirements and HealthConnect

HealthConnect is a proposed national electronic health record system, centred on electronic health event summaries, that capture all health encounters of those patients and health care professionals who "opt in" to the system. This article reports on key findings of an analysis of HealthConnect's data principles, systems and business architecture, from a records continuum perspective, and from recordkeeping requirements of reliability and authenticity. It concludes that HealthConnect lacks critical recordkeeping functionality and that inadequate policy with regard to ownership, consent and privacy impacts on the business and systems architecture, and consequently its ability to deliver trustworthy records.     

Introduction of a national electronic patient record in The Netherlands: some legal issues

The electronic patient record (EPR) is a major technological development within the healthcare sector. Many hospitals across Europe already use institution-based electronic patient records, which allow not only for electronic exchange of patient data within the hospital, but potentially also for sharing medical data with external healthcare providers, involved in the patient's care, such as general practitioners or pharmacists. In this article, we discuss the attempt made by the Dutch government to introduce a nationwide electronic patient record (n-EPR). Describing and analyzing the new legislation that is currently being developed to establish the infrastructure for the n-EPR and the related legal issues, we conclude that the introduction of a n-EPR give rise to some substantial concerns. These vary from technical and quality issues such as the reliability of patient data and sufficient standardization and interoperability of the systems used, to issues in the field of data security and confidentiality. For a successful introduction of the n-EPR within the healthcare sector, a condicio sine qua non is that the related legislation provides sufficient safeguards and clarity with respect to the responsibilities and liabilities of its main users: the healthcare professionals.     

Ethical and legal issues in suicide research

Moralist, libertarian and relativist ethical positions concerning suicide and its prevention are presented in order to clarify premises upon which ethical issues in suicide research may be resolved. Ethical concerns are differentiated from legal considerations and the implications of the vulnerability of suicidology research participants are discussed. Specific issues that arise in design, choice of participants, interpretation, diffusion of results and evaluative research are treated. These include: experimental methodologies, obtaining informed consent, deception and disclosure, studying innovative and unproven interventions, unknown consequences of participation, rescue criteria, disclosure of information to third parties, research with special populations, risks in publicizing results and measuring the value of human life. When specific legal obligations are lacking, ethical premises concerning the acceptability of suicide and obligations to intervene may influence research protocols.     

Medicare and Medicaid programs; electronic health record incentive program--stage 2. Final rule

This final rule specifies the Stage 2 criteria that eligible professionals (EPs), eligible hospitals, and critical access hospitals (CAHs) must meet in order to qualify for Medicare and/or Medicaid electronic health record (EHR) incentive payments. In addition, it specifies payment adjustments under Medicare for covered professional services and hospital services provided by EPs, eligible hospitals, and CAHs failing to demonstrate meaningful use of certified EHR technology (CEHRT) and other program participation requirements. This final rule revises certain Stage 1 criteria, as finalized in the July 28, 2010 final rule, as well as criteria that apply regardless of Stage.     

Ethical issues in international biomedical research: an overview

Human subjects research has been the focus of numerous controversies over the years. The dilemma lies between the potential harm to individuals who participate in research and the knowledge to be gained from the research study that might benefit society. When research is conducted in developing countries by researchers and sponsors from the United States and other industrialized countries, differences in history, culture, politics, wealth, and power between the countries give rise to unique challenges. In this Article, the author identifies several ethical issues to be considered when research is conducted in developing countries and provides the legal and ethical framework for their resolution.