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.     

From electronic health records to personal health records: emerging legal issues in the Italian regulation of e-health

In 2012, the Italian Legislator has provided an appropriate legal framework for the realisation of the national Electronic Health Records (EHR) system, in which the patient plays a pivotal role: with the implementation of the Fascicolo sanitario elettronico (FSE), patients will have access to their EHRs through the online platform, and decide which data to share and with whom. In this perspective, one of the most interesting innovations is the so-called ‘taccuino’, a digital space of patients’ FSE in which they can autonomously record data and information relating to their health. Patients’ ability to access their own health data and EHR at any time and to enter information by themselves in a personal area is a unique form of power at a European level, but their legal consequences are still vague. The aim of this contribution is to offer a first review of the Italian e-health reform, showing the most critical aspects.     

Ethical issues in HealthConnect's shared electronic health record system

Many countries are in the process of implementing systems of shared electronic health records. This article explores some of the ethical concerns raised by Australia's proposed HealthConnect system which aims to create electronic event summaries of health information. Three areas of ethical concern relating to confidentiality, consent and the involvement of the private sector are examined. It is argued that unless the HealthConnect system is firmly grounded in policy based on ethical considerations, patients may not want to "opt in" to it.     

HealthConnect and privacy: a policy conundrum

A shared electronic health record is intrinsically privacy-invasive because it creates a comprehensive record for information-sharing. The author explains the significance of information privacy and why it is that health information warrants special protection. She also provides an overview of the existing regulatory framework and an evaluation of suggested options and proposals for addressing privacy-related issues. Her analysis of suggested consent models suggests that they ultimately involve a trade-off between privacy and the broader benefits promised by HealthConnect and that obtaining the right balance is essential if HealthConnect is to achieve optimal health outcomes.     

Seven years until electronic health records: the negative effects of the new Stark exceptions and anti-kickback safe harbors

Last year's introduction of an exception to the Stark Regulations and a new Anti-Kickback safe harbor allows donors (mainly hospitals) to assist recipients (mainly physicians) with the establishment of electronic health records systems. This Article analyses the new regulations and makes the case that, among other negative effects, they will create an undesirable shift in physician referrals in the short term.     

HealthConnect and the duty of care: a dilemma for medical practitioners

This article asks whether medical practitioners' duty of care to their patients will encompass participation in the HealthConnect shared electronic records initiative. Medico-legal aspects of the HeathConnect scheme relating to the nature of shared electronic health record summaries (SEHRS) are examined, focusing on their function as an element of patient care and their ultimate purpose. The analysis is based on the premise that an incomplete and hence inaccurate shared electronic health record summary is clinically and legally more perilous than no record at all.     

Electronic health records: international, structural and legal perspectives

The EHR is a database record that incorporates a patient's health care details from conception to death and which can be distributed over a number of sites or aggregated at a particular source. This article describes the function and concept of the EHR by relating it to other medical information technologies, parallel changes in health care delivery, and a holistic health information model. The article compares the progress that Europe, Australia and the United States have made in the journey towards EHR implementation and concludes by highlighting some of the costs, barriers and consequences associated with the transition to a comprehensive EHR system.     

Medicaid program; time limitation on price recalculations and recordkeeping requirements under the drug rebate program. Final rule with comment period

On September 19, 1995, we published a proposed rule in the Federal Register that introduced requirements for States and manufacturers pertaining to the Medicaid drug rebate program. We received several comments from States and manufacturers regarding recordkeeping requirements and drug price recalculations. This final rule with comment period finalizes separately, in an accelerated timeframe, two specific provisions of the September 1995 proposed rule. It establishes new recordkeeping requirements for drug manufacturers under the Medicaid drug rebate program. It also sets forth a 3-year time limitation during which manufacturers must report changes to average manufacturer price and best price for purposes of reporting data to us. In addition, it announces the pressing need for codification of fundamental recordkeeping requirements. Furthermore, it announces our intention to continue to work on finalizing the complete drug rebate regulation for the Medicaid drug rebate program.     

Public Health Service--Information regarding requirements for health maintenance organizations. Correction notice: information regarding requirements for qualified health maintenance organizations

This notice corrects an error made in a Federal Register notice with respect to information regarding requirements for health maintenance organizations (HMO's).     

Final rules relating to use of electronic communication and recordkeeping technologies by employee pension and welfare benefit plans. Notice of final rulemaking

This document contains final rules under Title I of the Employee Retirement Income Security Act of 1974, as amended (ERISA), concerning the disclosure of certain employee benefit plan information through electronic media, and the maintenance and retention of employee benefit plan records in electronic form. The rules establish a safe harbor pursuant to which all pension and welfare benefit plans covered by Title I of ERISA may use electronic media to satisfy disclosure obligations under Title I of ERISA. The rules also provide standards concerning the use of electronic media in the maintenance and retention of records required by sections 107 and 209 of ERISA. The rules affect employee pension and welfare benefit plans, including group health plans, plan sponsors, administrators and fiduciaries, and plan participants and beneficiaries.