Pactuação da minuta da Política Nacional de Informação e Informática em Saúde - PNIIS

Início do Planejamento na Estratégia de Saúde Digital 2020-2028, Programa Conecte SUS e a Rede Nacional de Dados em Saúde. Acompanhamento do Tributal de Contas da União - Fortalecimento e revisão dos instrumentos de Governança em Saúde Digital - PNIIS.

[Health Data Hub: Why and how?] / Le Health Data Hub (suite) - Pourquoi ? Comment ?

TITLE: Le Health Data Hub (suite) - Pourquoi ? Comment ? ABSTRACT: Dans le monde de la recherche et de la santé publique, un consensus existe pour considérer que les données de santé constituent une ressource extrêmement précieuse pour de multiples usages, et qu'il convient d'en faciliter l'accès et le partage. Dans ce domaine, la France dispose de nombreux atouts, notamment de bases de données d'ampleur et de richesse sans doute uniques. Depuis quelques années, les pouvoirs publics ont pris conscience des enjeux autour de ces données et ont mis en place un dispositif technique, légal et réglementaire pour y faire face : le Système national des données de santé (SNDS) accompagné de la Plateforme des données de santé (PDS), plus communément appelée Health Data Hub (HDH). Cette plateforme est une infrastructure officiellement créée par un arrêté ministériel du 30 novembre 2019, destinée à faciliter l'accès et l'utilisation des données de santé afin de favoriser la recherche. On ne peut qu'applaudir une telle initiative qui constitue un progrès majeur et ouvre de nombreuses perspectives pour la recherche et la santé publique. Cependant, tel qu'il est conçu, le HDH pose divers problèmes qui amènent à questionner ses orientations actuelles.

Información clínica, consentimiento informado y deontología médica. Una relación reciente / Clinical information, informed consent and medical deontology. A recent relationship

El derecho a la información clínica y el consentimiento informado como expresión práctica del principio de autonomía, son conquistas legales en España de finales del siglo XX que se han trasladado a la normativa deontológica médica. Se estudia el ritmo de ese traslado. Revisión histórica de los diferentes códigos de deontología médica desde la Guerra Civil, buscando la presencia de estas ideas en ella. Hasta el código de 1979 la idea de información clínica no aparece en la normativa deontológica vigente y el consentimiento lo hace en casos muy restringidos. A partir de esa fecha su aparición es progresiva en los sucesivos códigos. Actualmente ambas ideas están completamente desarrolladas en la normativa deontológica española. La Deontología médica ha asumido como suyas las ideas de información al paciente y consentimiento in-formado. Este ha sido un proceso largo en el tiempo que ha cambiado en buena medida la orientación deontológica para las relaciones médico-enfermo. En estos aspectos, la Deontología médica pasa, de hacer hincapié en la prudencia del médico, a subrayar el deber de informar y de dar amplio espacio a las decisiones del paciente, al que reconoce como un agente moral autónomo y reflexivo, capaz de tomar sus propias decisiones sobre su salud

In Spain, the right to clinical information and informed consent as a practical expression of the principle of autonomy, are legal conquests achieved in the late twentieth century. From the law they have been transferred to the codes of medical deontology. The aim of this work is to study the pace of this transfer. Historical review of the different codes of medical deontology in Spain since the Civil War, see-king the presence of these ideas in them. Until code of medical deontology of 1979, the idea of clinical information did not appear in the contemporary deontological norm, and the rules on consent did so in very restricted cases. As of that date, their appearance is progressive in the successive codes. Currently, both concepts are fully developed in Spanish deontological regulations. Medical Deontology has take on the ideas of patient information and informed consent. This has been a long process which have brought considerable changes the deontological orientations of the traditional form of doctor-patient relationship. In these aspects, medical deontology has drifted, from emphasizing the prudence of the doctor, to emphasize the duty to inform and give ample space to the patient’s decisions, which he recognizes as an autonomous and reflective moral agent, capable of taking his own decisions about your health

National health information systems for achieving the Sustainable Development Goals.

OBJECTIVES: Achieving the Sustainable Development Goals will require data-driven public health action. There are limited publications on national health information systems that continuously generate health data. Given the need to develop these systems, we summarised their current status in low-income and middle-income countries. SETTING: The survey team jointly developed a questionnaire covering policy, planning, legislation and organisation of case reporting, patient monitoring and civil registration and vital statistics (CRVS) systems. From January until May 2017, we administered the questionnaire to key informants in 51 Centers for Disease Control country offices. Countries were aggregated for descriptive analyses in Microsoft Excel. RESULTS: Key informants in 15 countries responded to the questionnaire. Several key informants did not answer all questions, leading to different denominators across questions. The Ministry of Health coordinated case reporting, patient monitoring and CRVS systems in 93% (14/15), 93% (13/14) and 53% (8/15) of responding countries, respectively. Domestic financing supported case reporting, patient monitoring and CRVS systems in 86% (12/14), 75% (9/12) and 92% (11/12) of responding countries, respectively. The most common uses for system-generated data were to guide programme response in 100% (15/15) of countries for case reporting, to calculate service coverage in 92% (12/13) of countries for patient monitoring and to estimate the national burden of disease in 83% (10/12) of countries for CRVS. Systems with an electronic component were being used for case reporting, patient monitoring, birth registration and death registration in 87% (13/15), 92% (11/12), 77% (10/13) and 64% (7/11) of responding countries, respectively. CONCLUSIONS: Most responding countries have a solid foundation for policy, planning, legislation and organisation of health information systems. Further evaluation is needed to assess the quality of data generated from systems. Periodic evaluations may be useful in monitoring progress in strengthening and harmonising these systems over time.

[Reporting and information system for significant events related to radiation exposures in medicine: Structure, responsibilities and reporting criteria]. / Melde- und Informationssystem für bedeutsame Vorkommnisse bei Strahlenanwendungen in der Medizin: Struktur, Zuständigkeiten und Meldekriterien.

The increasing frequency and complexity of medical radiation exposures to humans inevitably result in higher risks of harmful unintended or accidental radiation exposures. To ensure a high level of protection and its continuous improvement, the Directive 2013/59/Euratom thus requires to systematically record and analyze both events and near-miss events as well as, in the case of their significance, to disseminate information regarding lessons learned from these events promptly and nationwide to improve radiation protection in medicine. These requirements have been transposed into German legislation by the new radiation protection law and radiation protection ordinance that entered into force simultaneously on December 31th, 2018. The reporting and information system as provided by these regulations as well as the tasks, duties and powers of the parties involved are presented in the first part of this review article. In the second part, the established application-specified criteria for the significance - and thus the notification requirement - of (near-miss) events are itemized and explicated.

Characteristics of Local Health Departments Associated with Implementation of Electronic Health Records and Other Informatics Systems.

OBJECTIVE: Assessing local health departments' (LHDs') informatics capacities is important, especially within the context of broader, systems-level health reform. We assessed a nationally representative sample of LHDs' adoption of information systems and the factors associated with adoption and implementation by examining electronic health records, health information exchange, immunization registry, electronic disease reporting system, and electronic laboratory reporting. METHODS: We used data from the National Association of County and City Health Officials' 2013 National Profile of LHDs. We performed descriptive statistics and multinomial logistic regression for the five implementation-oriented outcome variables of interest, with three levels of implementation (implemented, plan to implement, and no activity). Independent variables included infrastructural and financial capacity and other characteristics associated with informatics capacity. RESULTS: Of 505 LHDs that responded to the survey, 69 (13.5%) had implemented health information exchanges, 122 (22.2%) had implemented electronic health records, 245 (47.5%) had implemented electronic laboratory reporting, 368 (73.0%) had implemented an electronic disease reporting system, and 416 (83.8%) had implemented an immunization registry. LHD characteristics associated with health informatics adoption included provision of greater number of clinical services, greater per capita public health expenditures, health information systems specialists on staff, larger population size, decentralized governance system, one or more local boards of health, metropolitan jurisdiction, and top executive with more years in the job. CONCLUSION: Many LHDs lack health informatics capacity, particularly in smaller, rural jurisdictions. Cross-jurisdictional sharing, investment in public health informatics infrastructure, and additional training may help address these shortfalls.

When Does FDAMA Section 114 Apply? Ten Case Studies.

BACKGROUND: Section 114 of the Food and Drug Administration Modernization Act of 1997 regulates the promotion of health economic information by pharmaceutical companies to US health plans. Greater clarity is important given demands by payers and other stakeholders for evidence of value. OBJECTIVES: To develop hypothetical case studies of health economic promotions to examine legal and policy implications. METHODS: We constructed for pedagogical purposes 10 categories of potential health economic promotions. We generated hypothetical case studies for each category, including questions about whether each might be allowable under Section 114. The case studies were developed around the following categories: 1) costing out on-label clinical end points; 2) promotion of a costing exercise to physicians working in an accountable care organization setting; 3) burden-of-illness claims; 4) economic analysis of a formulary restriction policy; 5) extrapolations to doses, populations, or settings not covered in trials; 6) adherence claims; 7) "utilization of care" as a secondary end point in randomized clinical trials; 8) costing out a competitor drug's adverse event; 9) economic analysis of comparative effectiveness claims using an indirect treatment comparison; and 10) extrapolating from surrogate to long-term outcomes in an economic model. DISCUSSION: Most cases seem to fall into a gray zone given haziness around what constitutes "competent and reliable evidence" and "directly relate[d]" to an approved indication. In practice, it is difficult to know what the section allows given the imprecision of the statute and lack of guidance about its scope. CONCLUSION: Ideally, future guidance will provide clarity and flexibility.

Legal and regulatory considerations associated with use of patient-generated health data from social media and mobile health (mHealth) devices.

Patient-generated health data are coming into broader use across the health care spectrum and hold great promise as a means to improve care and health outcomes. At the same time, rapid evolution in the social media and mobile health (mHealth) market has promoted an environment in which creation and transmission of personal health information is easy, quick, and appealing to patients. However, adoption of social media and mHealth by providers is hampered by legal and regulatory concerns with regard to data ownership and data use. This article defines common forms of patient-generated health data (PGHD) and describes how PGHD is used in clinical settings. It explores issues related to protection of personal health information, including that of children and adolescents, data security, and other potential barriers such as physician licensure. It also discusses regulatory and legal considerations providers and patients should consider before using social media and mobile health apps.

The Rapid Alert System: implementation in NA 2 North LHA over the five-year period from 2008 to 2012.

INTRODUCTION: The Rapid Alert System was established by the European Union (EC Regulation 178/2002 Art.50, paragraph 1) for food intended for human consumption and for animal feed, with the aim of ensuring the protection of public, animal and environmental health. The purpose of the Rapid Alert System for Food and Feed (RASFF) is to provide the control authorities with the means of exchanging information on the measures taken to ensure food safety. This system allows for a rapid intervention following the discovery of food or feed already placed on the market and which represent, directly or indirectly, a serious risk for human, animal or environmental health. METHODS: Our work intends to examine all alert and information notified to the Hygiene Department of Food and Nutrition of what was formerly NA3 LHU in the last 5 years (2008-2012), and is now Naples 2 North LHU, bearing in mind that, according to regional law 16/2008 (10), the Local Health Units in Campania have been redefined. The types of risk regarding the food subject of the alerts received are: chemical, physical and biological. Food frauds (adulteration, counterfeiting, sophistication and alteration) and the poor state of preservation were considered separately. RESULTS: Out of 146 cases of non-conformity reported, 87 involved chemical risk, 28 biological risk and 17 included foreign bodies; there were also 7 food frauds and 1 case of poor state of preservation. As for the origin, the food subject of non-conformity were for the most part (61,64%) of national origin, while 34.24% came from abroad. Of these, about 66% were of non-EU origin. CONCLUSIONS: The experience gained during the period from 2008 to 2012 allows us to state that the information flow has been improved allowing local services that have been assigned the control to act more rapidly. A critical issue sometimes remains concerning the completeness of the given data, above all regarding the type of risk that, when well reported, provides a valuable contribution to the success of a comprehensive and responsible risk management programme. The encouraging fact that emerges from this study, however, is that, despite the premises made about the characteristics of the area examined, the number of alerts we received involving production sites located in the area of the LHU jurisdiction is less than what we might have expected.

Why common carrier and network neutrality principles apply to the Nationwide Health Information Network (NWHIN).

The Office of the National Coordinator will be defining the architecture of the Nationwide Health Information Network (NWHIN) together with the proposed HealtheWay public/private partnership as a development and funding strategy. There are a number of open questions--for example, what is the best way to realize the benefits of health information exchange? How valuable are regional health information organizations in comparison with a more direct approach? What is the role of the carriers in delivering this service? The NWHIN is to exist for the public good, and thus shares many traits of the common law notion of 'common carriage' or 'public calling,' the modern term for which is network neutrality. Recent policy debates in Congress and resulting potential regulation have implications for key stakeholders within healthcare that use or provide services, and for those who exchange information. To date, there has been little policy debate or discussion about the implications of a neutral NWHIN. This paper frames the discussion for future policy debate in healthcare by providing a brief education and summary of the modern version of common carriage, of the key stakeholder positions in healthcare, and of the potential implications of the network neutrality debate within healthcare.

Kenya's health workforce information system: a model of impact on strategic human resources policy, planning and management.

OBJECTIVE: Countries worldwide are challenged by health worker shortages, skill mix imbalances, and maldistribution. Human resources information systems (HRIS) are used to monitor and address these health workforce issues, but global understanding of such systems is minimal and baseline information regarding their scope and capability is practically non-existent. The Kenya Health Workforce Information System (KHWIS) has been identified as a promising example of a functioning HRIS. The objective of this paper is to document the impact of KHWIS data on human resources policy, planning and management. METHODS: Sources for this study included semi-structured interviews with senior officials at Kenya's Ministry of Medical Services (MOMS), Ministry of Public Health and Sanitation (MOPHS), the Department of Nursing within MOMS, the Nursing Council of Kenya, Kenya Medical Practitioners and Dentists Board, Kenya's Clinical Officers Council, and Kenya Medical Laboratory Technicians and Technologists Board. Additionally, quantitative data were extracted from KHWIS databases to supplement the interviews. Health sector policy documents were retrieved from MOMS and MOPHS websites, and reviewed to assess whether they documented any changes to policy and practice as having been impacted by KHWIS data. RESULTS: Interviews with Kenyan government and regulatory officials cited health workforce data provided by KHWIS influenced policy, regulation, and management. Policy changes include extension of Kenya's age of mandatory civil service retirement from 55 to 60 years. Data retrieved from KHWIS document increased relicensing of professional nurses, midwives, medical practitioners and dentists, and interviewees reported this improved compliance raised professional regulatory body revenues. The review of Government records revealed few references to KHWIS; however, documentation specifically cited the KHWIS as having improved the availability of human resources for health information regarding workforce planning, management, and development. CONCLUSION: KHWIS data have impacted a range of improvements in health worker regulation, human resources management, and workforce policy and planning at Kenya's ministries of health.