Researching the Appropriateness of Care in the Complementary and Integrative Health Professions Part 2: What Every Researcher and Practitioner Should Know About the Health Insurance Portability and Accountability Act and Practice-based Research in the United States.

OBJECTIVE: This paper describes a process for ensuring and documenting Health Insurance Portability and Accountability Act (HIPAA) compliance in clinical practice-based research. METHODS: The Center of Excellence for Research in Complementary and Alternative Medicine was funded by National Center for Complementary and Integrative Health to develop the methods for researching the appropriateness of care in complementary and integrative health, which previously was known as complementary and alternative medicine. We recruited 125 participating chiropractic clinics for enrolling patients and gathering their data via the online surveys. Chiropractic clinics completed the following: (1) obtained the files of patients who provided prior consent (the prospective sample), (2) obtained the files of the patients selected randomly using specified randomization procedures (the retrospective sample), and (3) transferred all patient data to the RAND Corporation via an encrypted file. RESULTS: Most of the doctors of chiropractic from clinical practices had no concerns about obtaining and transferring the files of patients who provided informed consent. However, some doctors were uneasy about allowing the researchers to access the randomly selected files of patients who had not provided prior authorization. This led us to develop a set of forms to provide clinics about HIPAA compliance. CONCLUSION: For this study, we provided clinics with information about the rules under HIPAA, demonstrated how the study complied with those rules, explained the logic behind the necessity for collecting files from both the prospective and retrospective samples, and, if requested, provided clinics with a confidentiality agreement signed by the study principal investigator and an organizational contracts representative. The process we developed may assist other complementary and integrative health researchers and practitioners in future studies.

Clinical Trials, Data Protection and Patient Empowerment in the Era of the New EU Regulations.

Cancer clinical trials and, in general, cancer clinical research by definition need a multi-modality approach. It is not enough to discover and register new drugs. To get cancer under control requires us to perform complex clinical studies that integrate drugs, companion diagnostics, new or improved surgical procedures and new radiotherapy approaches as well as, most importantly, to integrate all available information. This includes biological material and, of increasing importance, large amounts of data using big data technologies. To personalise treatment, genetic data are more and more frequently used. Therefore, the general approach is holistic. Legislators, on the other hand, work in a silo mentality; the needs of clinical research are poorly understood, and legislation focuses on either health care or the commercialisation of a product, and not on clinical research. In the last 2 years the EU has drafted several major regulations touching on clinical trials, in vitro diagnostics, medical devices and data protection, all of which will impact clinical research, although the silo mentality makes the overall framework inconsistent and potentially highly damaging to the EU's capacity to make rapid progress in the field of personalised medicine.

Understanding the Code: scope of the duty of confidentiality.

In a series explaining the law underpinning the Nursing and Midwifery Council's revised Code (2015), this month's article considers the scope of a district nurse's duty of confidence. The article explains how three areas of law are drawn together to provide maximum protection against inappropriate disclosure of sensitive health information.

Implementation of the Directive 2011/24/EU in the Czech Republic.

The article describes implementation of the Directive 2011/24/EU in the Czech Republic, its consequences with individual patient's rights and financing of healthcare for citizens of the European Union.

[Epidemiological cancer registries in Germany: history from a legal point of view]. / Epidemiologische Krebsregister in Deutschland : Historie im Wandel rechtlicher Vorgaben.

Despite decades of efforts, the establishment of a satisfactory nationwide, population-based cancer registry for Germany was very slow. The reason for this until 1990 was the lack of coverage or the-apart from the Saarland-inadequate degree of coverage in the old federal states. The former East Germany, however, had a comprehensive cancer registry. Starting in 1990, decisive obstacles-especially when considering data protection needs and the distribution of powers between federal and state governments-could be overcome. On the basis of an open-ended federal law and state requirements, a nationwide cancer registry with analysis of the collected data for epidemiological purposes has been achieved.

Ethics and electronic health information technology: challenges for evidence-based medicine and the physician-patient relationship.

OBJECTIVES: The National Health Insurance Scheme (NHIS), and the National Identification Authority (NIA), pose ethical challenges to the physician-patient relationship due to interoperability. This paper explores (1) the national legislation on Electronic Health Information Technology (EHIT), (2) the ethics of information technology and public health and (3) the effect on the Physician-patient relationship. METHOD: This study consisted of systematic literature and internet review of the legislation, information technology, the national health insurance program, and the physician-patient relationship. RESULT: The result shows that (1) EHIT have eroded a big part of the confidentiality between the physician and patient; (2) The encroachment on privacy is an inevitable outcome of EHIT; (3) Legislation on privacy, the collection, storage and uses of electronic health information is needed and; (4) the nexus between EHIT, NHIS, NHA, Ethics, the physician-patient relationship and privacy. CONCLUSION: The study highlights the lack of protection for physician-patient relationship as medical practice transitions from the conventional to the modern, information technology driven domain.

FDA's expanding postmarket authority to monitor and publicize food and consumer health product risks: the need for procedural safeguards to reduce "transparency" policy harms in the post-9/11 regulatory environment.

This article provides a summary of the expansion of FDA's discretionary authority in the post-9/11 period, particularly with respect to FDA's authority to monitor and publicize potential health risks linked to food, dietary supplements, nonprescription drugs, and other consumer health products. In addition, this article evaluates the need for FDA to establish procedural safeguards to reduce the significant risks of unintended and undue harm to people and regulated companies that can result from adverse publicity in the more "transparent" post 9/11 FDA regulatory environment. Specifically, Part I summarizes the amendments to the FDCA enacted during the post-9/11 period that have expanded FDA's postmarket authority to monitor, evaluate, and publicize potential health risks linked to food, dietary supplements, nonprescription drugs and other consumer health products marketed in the United States, in conjunction with FDA's Sentinel Initiative, Reportable Food Registry, and other adverse event reporting requirements. Part II discusses the convergence of FDA's expanded postmarket authority to publicize product-related risks with President Obama's transparency initiative aimed at fostering "open government" through increased public access to government information. In addition, Part II considers the nature of the procedural safeguards needed in the post-9/11 FDA regulatory environment, in view of FDA's historical record and illustrative cases that help expose how adverse "transparency" surrounding FDA warning letters, recalls and safety alerts concerning products in the marketplace can have undue and unintended prejudicial and harmful effects for the people and companies that are legally responsible for such products. Finally, based on these analysis, this article concludes with some observations concerning the nature of the procedural safeguards needed to reduce the significant risks of "transparency" policy harms in the pos-9/11 regulatory environment.

Informed consent for videoconsultations in Canada.

We performed a qualitative study of the practice of informed consent for videoconsultation in Canada. Fourteen cases were examined: the 13 provinces and territories, and the Federal jurisdiction representing aboriginal groups. Twenty-seven interviews were conducted with key informants (14 telehealth experts, 13 legal experts). The telehealth experts were people with direct experience of telehealth practice. The majority of the telehealth experts agreed that videoconsultations had not been integrated into the health-care system. An interesting finding of the study was that the integration status of videoconsultations was not indicative of informed consent practices. Telehealth providers favoured express written consent, or risk management practices, although there was a desire to move towards implied consent models for videoconsultations. The study also showed that the legal ramifications of the electronic transmission of non-recorded, real-time, personal health information had not been explored. This represents an important factor in guiding future consent for videoconsultations in Canada.

The next step in health data exchanges: trust and privacy in exchange networks.

The rapid development of health information exchanges (HIE), regional health information organizations (RHIO), the Nationwide Health Information Network (NHIN) and other data exchange platforms for health records creates complex and multifaceted challenges for protecting the privacy and security of health information. Often these issues are addressed in a contractual agreement between two parties seeking to exchange data. Until recently, this point-to-point approach has been acceptable because there were few operational HIEs or RHIOs that were ready, willing and able to actually exchange data. With the proliferation of HIEs and RHIOs that are either operational or on the cusp of being operational, the utility of point-to-point is diminishing. It is no longer efficient for a RHIO to negotiate a separate data exchange agreement with every one of its exchange partners. The evolving model for data exchange agreements is a multi-party trust agreement. This article will examine the crucial components of a multi-party trust agreement.

Paternity testing requested by private parties in Italy: some ethical considerations.

In Italy, judicial and extrajudicial requests for paternity testing have increased in recent years. A retrospective analysis of such private extrajudicial requests received by the legal medicine unit of the Department of Environmental Medicine and Public Health of Padua University was conducted to identify problem areas most helpful in determining whether to accept private parties' requests for paternity testing. Such testing is most delicate when a presumptive father may be seeking to disown paternity and when testing is wanted without the consent of a member of the mother-child-father triangle. Tests that could establish paternity where none has been recognised are less problematic, as the child will not lose out. Legal and ethical-deontological aspects of consent, of the protection of minors and of children's and parents' need for follow-up interviews to deal with the outcome of such testing are carefully considered by the Padua University team when deciding whether to accept a request for testing. It is argued that because such issues are not dealt with by mail-order laboratories, the use of such services is inappropriate.

The remains of the body: human tissue, competence and consent in an age of profit.

Over the past few decades human tissues and fluids have increasingly become of interest to health-oriented research due to their potential use in the development of new diagnostic tools, drugs and treatment modalities. They have also become valuable commodities that figure prominently in the recovery of hormones for cosmetic purposes, the production of proteins and in a whole range of uses in the biopharmacological industry. Unfortunately, current understanding of the ethical and legal status of human tissue and fluids, and of the conditions under which they may be recovered and used, is somewhat uneven. The aim of this presentation is to outline the ethical and legal considerations that must be met if a recovery and use protocol is to meet appropriate standards.

Distinctiveness of management in a university psychiatric hospital as a public health institution.

The distinctiveness of management of a university psychiatric hospital which has the status of a public health institution is manifested in the following ways: * Distinctive features and characteristics of managing service provider organizations compared to those whose operational results involve tangible products; * Distinctive features of management which originate from its role as a regional hospital and a tertiary research and educational institution in the field of psychiatry, with special importance for the Republic of Slovenia as a whole; * Distinctive features of management that are defined by the social and legal framework of operation of public health institutions and their special social mission. This paper therefore discusses the specific theoretical and practical findings regarding management of service provider organizations from the viewpoint of their social mission and significance, as well as their legal organization, internal structure and values.