Informing relatives of their genetic risk: an examination of the Belgian legal context.

Findings from genomic sequencing can have important implications for patients and relatives. For this reason, most professional guidelines support that patients have an ethical duty to inform relatives and, when disclosure does not occur, most guidelines allow health-care professionals (HCPs) to breach confidentiality. Translating the ethical duties to respect the patient's confidentiality and prevent harm in at-risk relatives into legislation is a complex issue due to the both personal and familial nature of genetic information. In many countries there is no specific guideline or law addressing family communication of genetic information and thus it is unclear what duties patients and HCPs have towards at-risk relatives. Using Belgium as an example for countries in which this is the case, we examined the existing Belgian legislation in relation to three central topics: (1) patients' duties to family members, (2) respect for patient confidentiality and privacy, and (3) HCPs' duties to family members. We then investigated international legal frameworks and compared it with the Belgian context to see to what degree international precedent could aid in the interpretation of Belgian law. Based on our review of the legislation, we make recommendations for the interpretation of current law and examine whether there is sufficient legal precedent to answer the questions central to family communication of genetic information. Although we focus on the specific Belgian legislation, the discussions are relevant for many other countries that have similar legislative approaches.

Remote monitoring of cardiac implanted electronic devices: legal requirements and ethical principles - ESC Regulatory Affairs Committee/EHRA joint task force report.

The European Union (EU) General Data Protection Regulation (GDPR) imposes legal responsibilities concerning the collection and processing of personal information from individuals who live in the EU. It has particular implications for the remote monitoring of cardiac implantable electronic devices (CIEDs). This report from a joint Task Force of the European Heart Rhythm Association and the Regulatory Affairs Committee of the European Society of Cardiology (ESC) recommends a common legal interpretation of the GDPR. Manufacturers and hospitals should be designated as joint controllers of the data collected by remote monitoring (depending upon the system architecture) and they should have a mutual contract in place that defines their respective roles; a generic template is proposed. Alternatively, they may be two independent controllers. Self-employed cardiologists also are data controllers. Third-party providers of monitoring platforms may act as data processors. Manufacturers should always collect and process the minimum amount of identifiable data necessary, and wherever feasible have access only to pseudonymized data. Cybersecurity vulnerabilities have been reported concerning the security of transmission of data between a patient's device and the transceiver, so manufacturers should use secure communication protocols. Patients need to be informed how their remotely monitored data will be handled and used, and their informed consent should be sought before their device is implanted. Review of consent forms in current use revealed great variability in length and content, and sometimes very technical language; therefore, a standard information sheet and generic consent form are proposed. Cardiologists who care for patients with CIEDs that are remotely monitored should be aware of these issues.

Legal aspects of personal health monitoring.

Personal health monitoring (PHM) can be defined as comprising all technical systems, processing, collecting, and storing of data linked to a person. PHM involves several legal issues that are described in this paper. This article analyses firstly the short term actions that are needed at the European level to allow personal health monitoring in respect of the interests and rights of patients such as the need to have more harmonised medical liability rules at the EU level. Introducing PHM implies also legal action at the EU level on the long run. These long-term actions are related to e.g. the way in which hospitals are organised in their relation with healthcare professionals and with other hospitals or healthcare actors. The paper analyses finally also how health monitoring projects may change the traditional (non-)relationship between patients and pharmaceutical/medical device industry. Today, the producers and distributors of medicinal products have no specific contact with patients. This situation may change when applying telemonitoring projects and may require new legal rules.

Legal aspects of personalized health monitoring.

Personal health monitoring (PHM) can be defined as comprising all technical systems, processing, collecting, and storing of data linked to a person. PHM involves several legal issues that are described in this article. This article analyses firstly the short-term actions that are needed at the European level to allow personal health monitoring in respect of the interests and rights of patients such as the need to have more harmonized medical liability rules at the EU level. Introducing PHM implies also legal action at the EU level on the long run. These long-term actions are related to e.g., the way in which hospitals are organized in their relation with healthcare professionals and with other hospitals or healthcare actors. The paper will finally analyse also how health monitoring projects may change the traditional (non-) relationship between patients and pharmaceutical/medical device industry. Today, the producers and distributors of medicinal products have no specific contact with patients. This situation may change when applying telemonitoring projects and may require to new legal rules.

Competition rules and health care players: principles and consequences.

PURPOSE: Competition rules maximise consumer welfare by promoting efficient use of scarce resource and thus high output, low prices, high quality, varied services, innovation, production and distribution. European courts consider doctors and hospital staff as undertakings (any entity that performs economic activities), so that if they enter into agreements then they have to comply with competition rules. This paper's objective is to determine whether competition law, which applies to undertakings, can in fact be applied to different healthcare-sector players and whether specific rules are needed regarding competition between healthcare undertakings. DESIGN/METHODOLOGY/APPROACH: Data were selected from relevant European and national case law, European institution legal documents (such as regulations, guidelines and communications) and healthcare competition law literature, and then examined. FINDINGS: The paper finds that competition rules are applicable to healthcare players considering the consequences if competition rules are applied to the healthcare market. For market processes to result in the appropriate cost, quality and output, competition law must be proactive. In other words, quality must be fully factored into the competitive mix, allowing consumers to weigh healthcare price and non-price characteristics. RESEARCH LIMITATIONS/IMPLICATIONS: Countries have different healthcare system and competition rules (although similar), competition rule impact is different for each country. Some healthcare systems are more regulated and there will be less opportunity for healthcare players to compete. PRACTICAL IMPLICATIONS: Efficiently applying competition law to healthcare players means that several challenges need facing, such as healthcare quality complexity and court scepticism. ORIGINALITY/VALUE: This article points out the challenges when competition law is applied to the healthcare sector and how these challenges are faced in certain countries such as The Netherlands.

Monitoring quality in a federal state with shared powers in healthcare: the case of Belgium.

The Belgian healthcare system consists of a complex of more or less autonomous groups of healthcare providers. It is the responsibility of the government to ensure that the fundamental right to qualitative healthcare is secured through the services they provide. In Belgium, the regulatory powers in healthcare are divided between the federal state and the three communities. Both levels, within their area of competence, monitor the quality of healthcare services. Unique to the Belgian healthcare system is that the government that providers are accountable to is not always the same as the government that is competent to set the criteria. The goal of this article is to provide an overview of the main mechanisms that are used by the federal government and the government of the Flemish community to monitor healthcare quality in hospitals. The Flemish community is Belgian's largest community (6.2 million inhabitants). The overview is followed by a critical analysis of the dual system of quality monitoring.

Legal aspects of E-HEALTH.

Cross-border activities in health care in the European single market are increasing. Many of these cross-border developments are related to e-Health. E-Health describes the application of information and communication technologies across the whole range of functions that affect the health care sector. E-health attracts a growing interest on the European level that highlights the sharp need of appropriate regulatory framework able to ensure its promotion in the European Union. Some Directives constitute a step in this direction. Both the Data Protection Directive, the E-Commerce Directive, the Medical Device Directive and the Directive on Distance Contracting are some of the most important European legal achievements related to e-Health. Although the directives are not adopted especially for e-health applications, they are indirectly very important for e-Health. Firstly, the Data Protection Directive applies to personal data which form part of a filing system and contains several important principles that have to be complied with by e-Health actors processing personal data concerning health. Secondly, the E-commerce Directive applies to services provided at a distance by electronic means. Many e-Health applications fall within this scope. Thirdly, the Medical Devices Directive is of importance for the e-Health sector, especially with regard to e.g. the medical software that is used in many e-health applications. Finally, the Directive on Distance Contracting applies to contracts for goods or services which make use of one or more means of distance communication; E-Health business may involve the conclusion of contracts. Despite these Directives more developments are needed at the European level in order to make sure that e-Health will play an even more important role in health care systems than is the case today. The new e-Health applications like electronic health records, e-health platforms, health grids and the further use of genetic data and tissue involve new legal challenges. Several member states are introducing electronic health records or e-Health platforms. The use of electronic health records that contain data of several health actors poses new risks with some legal consequences. Recently, grids are being used in some ambitious medical and healthcare applications. In order to be truly effective such grid applications must draw together huge amounts of data from disparately located computers - which implies data sharing across jurisdictions and the sharing of responsibilities by a range of different data controllers. E-Health will also enhance the further use of human tissue and genetic data. More and clear guidelines on the reimbursement criteria for telemedicine and on liability would also be very useful. Guidance at the European level can be given as to the criteria that (tele-) health sessions will have to comply with for reimbursement purposes, since it is still unclear when e-Health sessions will be reimbursed. It is clear that the existing European legal framework is not finished yet and that more specific European rules are needed.

Legal thoughts on the implications of cost-reducing guidelines for the quality of health care.

Health care expenditures in European countries are increasing. Many cost containment mechanisms have been developed, one of which is the introduction of clinical practice guidelines in binding legislation. In developing recent patients' rights laws, many legislators refer to practice guidelines when specifying the right to quality in health care. The courts often follow this example. Initially, practice guidelines were used to improve the quality of care. Recently, their potential to reduce costs is being discovered by policy makers and compliance with the cost-controlling guidelines is mandatory and subject to financial sanctions. This article will question the impact of the 'new generation' guidelines aimed at reducing health care costs and their impact on the quality of care, in particular. The authors will analyse whether a physician, in case of a conflict with a patient, who claims that his right to quality care has been violated, can defend himself in court by stating that he complied with 'financially' inspired guidelines, especially now that non-compliance with these guidelines is sanctioned.

Telemedicine and European law.

A Directive of the European Union was first published in 2000, which dealt with telemedicine as part of its provisions. This E-Commerce Directive, as it became known, was subjected to further study which revealed some problems relative to the practice of telemedicine. Among the subjects discussed in this paper are those of privacy, data protection, free movement of services, the impact of electronic communication and ethical issues.