Juridiske rammevilkår for etablering av helseregistre og utlevering av data i forbindelse med forskning

Før et forskningsprosjekt kan settes i gang, må forskere forholde seg til en rekke omfattende søknadsprosedyrer. I denne artikkelen belyses forhold som er spesielt aktuelle for forskere, slik som muligheter og begrensninger for innhenting av data til forskning og tilgjengelighet av data fra sentrale helseregistre. Som bakgrunn benyttes helseregisterloven og tilhørende forskrifter for de sentrale helseregistrene. Regler om dispensasjon fra taushetsplikt blir også nærmere belyst.English SummaryBefore a research project can be initiated, researchers must relate to a series of comprehensive procedures for making an application. In this article, the conditions that are particularly relevant for researchers, such as the possibilities and restrictions for collecting data for research purposes, and for obtaining access to data from central health registers, are discussed. The Personal Health Data Filing System Act and related regulations are used as background for the discussion. The regulations relating to exemption from the duty of confidentiality are also discussed.

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Osteoporoseforskning i Tromsø

Norsk Epidemiologi ◽

10.5324/nje.v5i2.265 ◽

2009 ◽

Vol 5 (2) ◽

Author(s):

Gro K.R. Berntsen m.fl.

Keyword(s):

Bone Mineral Density ◽

Bone Mineral ◽

Large Population ◽

Osteoporotic Fractures ◽

Population Based ◽

English Summary ◽

Font Size ◽

Mineral Density ◽

Population Based Study ◽

Access To Data

SAMMENDRAGTromsø Osteoporose Studie (TROST) er knyttet til den fjerde store befolkningsundersøkelsen somgjennomføres i Tromsø. Vår tilgang til Tromsøundersøkelsenes kartlegging av livsstilsfaktorer,risikofaktorer for hjerte-kar sykdom samt flere kliniske- og laboratoriemålinger i befolkningen gjennom desiste 20 år gjør TROST til en unik studie i verdenssammenheng. Pr 1. oktober 1995 vil vi ha undersøktbentetthet i underarm hos ca. 8 000 personer. De fire delprosjektene som drives under TROST tar for segbentetthet, biokjemiske markører for osteoporose, klinisk osteoporose og brudd. En nærmere presentasjonav hvert prosjekt gis i teksten.Berntsen GKR, Midtby M, Ringberg TM, Joakimsen RM, Magnus JH, Tollan A, Fønnebø V, Søgaard AJ.Research on osteoporosis in Tromsø. ENGLISH SUMMARYThe Tromsø Osteoporosis Study (TROST) is part of the fourth large population based study beingconducted in Tromsø, Norway. Our access to data from the current and previous Tromsø studies providinginformation on lifestyle factors, risk factors for cardiovascular disease, and several clinical and laboratorymeasurements in the population throughout the last 20 years makes TROST a unique study internationally.By October 1, 1995, we will have examined bone mineral density in the forearm of 8 000 subjects. The fourresearch projects under TROST focus on determinants of bone mineral density, biochemical markers ofosteoporosis, clinical osteoporosis and determinants of osteoporotic fractures. A presentation of eachproject is given in the text.Nor J Epidemiol 1995; 5 (2): 171-174.

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Health informatics. Guidance for handling personal health data in international applications in the context of the EU data protection directive

10.3403/02961887u ◽

2015 ◽

Keyword(s):

Data Protection ◽

Health Informatics ◽

Health Data ◽

Personal Health ◽

Data Protection Directive ◽

The Eu

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(Preprint)

10.2196/preprints.12279 ◽

2018 ◽

Author(s):

Ram Dixit ◽

Sahiti Myneni

Keyword(s):

Cancer Survivors ◽

Mental Models ◽

Health Systems ◽

Information Needs ◽

Health Data ◽

Information Architecture ◽

Personal Health ◽

User Centered Design ◽

Card Sort ◽

Connected Health

BACKGROUND Connected Health technologies are a promising solution for chronic disease management. However, the scope of connected health systems makes it difficult to employ user-centered design in their development, and poorly designed systems can compound the challenges of information management in chronic care. The Digilego Framework addresses this problem with informatics methods that complement quantitative and qualitative methods in system design, development, and architecture. OBJECTIVE To determine the accuracy and validity of the Digilego information architecture of personal health data in meeting cancer survivors’ information needs. METHODS We conducted a card sort study with 9 cancer survivors (patients and caregivers) to analyze correspondence between the Digilego information architecture and cancer survivors’ mental models. We also analyzed participants’ card sort groups qualitatively to understand their conceptual relations. RESULTS We observed significant correlation between the Digilego information architecture and cancer survivors’ mental models of personal health data. Heuristic analysis of groups also indicated informative discordances and the need for patient-centric categories relating health tracking and social support in the information architecture. CONCLUSIONS Our pilot study shows that the Digilego Framework can capture cancer survivors’ information needs accurately; we also recognize the need for larger studies to conclusively validate Digilego information architectures. More broadly, our results highlight the importance of complementing traditional user-centered design methods and innovative informatics methods to create patient-centered connected health systems.

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The funhouse mirror: the I in personalised healthcare

Life Sciences Society and Policy ◽

10.1186/s40504-020-00108-0 ◽

2021 ◽

Vol 17 (1) ◽

Author(s):

Mira W. Vegter ◽

Hub A. E. Zwart ◽

Alain J. van Gool

Keyword(s):

Precision Medicine ◽

Personal Data ◽

Health Data ◽

Personal Health ◽

Lifestyle Interventions ◽

Phenotypic Data ◽

Individual Health ◽

Data Source ◽

Tracking Devices ◽

Personalised Healthcare

AbstractPrecision Medicine is driven by the idea that the rapidly increasing range of relatively cheap and efficient self-tracking devices make it feasible to collect multiple kinds of phenotypic data. Advocates of N = 1 research emphasize the countless opportunities personal data provide for optimizing individual health. At the same time, using biomarker data for lifestyle interventions has shown to entail complex challenges. In this paper, we argue that researchers in the field of precision medicine need to address the performative dimension of collecting data. We propose the fun-house mirror as a metaphor for the use of personal health data; each health data source yields a particular type of image that can be regarded as a ‘data mirror’ that is by definition specific and skewed. This requires competence on the part of individuals to adequately interpret the images thus provided.

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Exchanging personal health data with electronic health records: A standardized information model for patient generated health data and observations of daily living

International Journal of Medical Informatics ◽

10.1016/j.ijmedinf.2018.10.006 ◽

2018 ◽

Vol 120 ◽

pp. 116-125 ◽

Cited By ~ 3

Author(s):

Panagiotis Plastiras ◽

Dympna O’Sullivan

Keyword(s):

Electronic Health Records ◽

Daily Living ◽

Information Model ◽

Health Data ◽

Personal Health ◽

Health Records ◽

Electronic Health

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Public Interest, Health Research and Data Protection Law: Establishing a Legitimate Trade-Off between Individual Control and Research Access to Health Data

Laws ◽

10.3390/laws9010006 ◽

2020 ◽

Vol 9 (1) ◽

pp. 6 ◽

Cited By ~ 3

Author(s):

Mark J. Taylor ◽

Tess Whitton

Keyword(s):

Public Interest ◽

Data Protection ◽

Health Research ◽

Health Data ◽

Personal Health ◽

Positive Contribution ◽

Data Governance ◽

The Public ◽

Individual Control ◽

Data Protection Law

The United Kingdom’s Data Protection Act 2018 introduces a new public interest test applicable to the research processing of personal health data. The need for interpretation and application of this new safeguard creates a further opportunity to craft a health data governance landscape deserving of public trust and confidence. At the minimum, to constitute a positive contribution, the new test must be capable of distinguishing between instances of health research that are in the public interest, from those that are not, in a meaningful, predictable and reproducible manner. In this article, we derive from the literature on theories of public interest a concept of public interest capable of supporting such a test. Its application can defend the position under data protection law that allows a legal route through to processing personal health data for research purposes that does not require individual consent. However, its adoption would also entail that the public interest test in the 2018 Act could only be met if all practicable steps are taken to maximise preservation of individual control over the use of personal health data for research purposes. This would require that consent is sought where practicable and objection respected in almost all circumstances. Importantly, we suggest that an advantage of relying upon this concept of the public interest, to ground the test introduced by the 2018 Act, is that it may work to promote the social legitimacy of data protection legislation and the research processing that it authorises without individual consent (and occasionally in the face of explicit objection).

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Trender i insidens og mortalitet av kreft i Norge

Norsk Epidemiologi ◽

10.5324/nje.v11i2.554 ◽

2009 ◽

Vol 11 (2) ◽

Author(s):

Steinar Tretli ◽

Trude Eid Robsahm ◽

Elisabeth Svensson

Keyword(s):

Case Fatality ◽

English Summary ◽

Classification Rules ◽

Font Size ◽

Treatment Results ◽

Mortality Trends ◽

Calendar Time ◽

Incidence And Mortality ◽

Short Time ◽

Over Time

ENGLISH SUMMARYTretli S, Robsahm TE, Svensson E. Time trends in cancer incidence and mortality in Norway.Nor J Epidemiol 2001; 11 (2): 177-185.The aim of this study is to decribe the trends in incidence and mortality of cancer by calendar time.Most types of cancer, except those with high case fatality short time after the diagnosis, demonstrate alarger increase in incidence than in mortality over time. For persons below 70 years of age during theperiod 1931-95 the mortality rate has been close to constant. Obviously, the mortality of lung andstomach cancer has changed over time, however, these have changed in different direction and almostlevelled out. In this paper, it is discussed how registration routines, classification rules, treatment resultsand the basis of the diagnosis can influence the incidence and mortality trends.

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Visualizing Knowledge Evolution Trends and Research Hotspots of Personal Health Data Research: Bibliometric Analysis (Preprint)

10.2196/preprints.31142 ◽

2021 ◽

Author(s):

Jianxia Gong ◽

Vikrant Sihag ◽

Qingxia Kong ◽

Lindu Zhao

Keyword(s):

Health Care ◽

Human Factors ◽

Computer Science ◽

Bibliometric Analysis ◽

Focal Point ◽

Empirical Studies ◽

Health Data ◽

Personal Health ◽

Knowledge Evolution ◽

Research Hotspots

BACKGROUND The recent surge in clinical and nonclinical health-related data has been accompanied by a concomitant increase in personal health data (PHD) research across multiple disciplines such as medicine, computer science, and management. There is now a need to synthesize the dynamic knowledge of PHD in various disciplines to spot potential research hotspots. OBJECTIVE The aim of this study was to reveal the knowledge evolutionary trends in PHD and detect potential research hotspots using bibliometric analysis. METHODS We collected 8281 articles published between 2009 and 2018 from the Web of Science database. The knowledge evolution analysis (KEA) framework was used to analyze the evolution of PHD research. The KEA framework is a bibliometric approach that is based on 3 knowledge networks: reference co-citation, keyword co-occurrence, and discipline co-occurrence. RESULTS The findings show that the focus of PHD research has evolved from medicine centric to technology centric to human centric since 2009. The most active PHD knowledge cluster is developing knowledge resources and allocating scarce resources. The field of computer science, especially the topic of artificial intelligence (AI), has been the focal point of recent empirical studies on PHD. Topics related to psychology and human factors (eg, attitude, satisfaction, education) are also receiving more attention. CONCLUSIONS Our analysis shows that PHD research has the potential to provide value-based health care in the future. All stakeholders should be educated about AI technology to promote value generation through PHD. Moreover, technology developers and health care institutions should consider human factors to facilitate the effective adoption of PHD-related technology. These findings indicate opportunities for interdisciplinary cooperation in several PHD research areas: (1) AI applications for PHD; (2) regulatory issues and governance of PHD; (3) education of all stakeholders about AI technology; and (4) value-based health care including “allocative value,” “technology value,” and “personalized value.”

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Use of Existing Health Data in Epidemiologic Research–Issues of Informed Consent Under Normal Circumstances and at a Time of Health Crises

Clinical Oncology and Research ◽

10.31487/j.cor.2020.06.09 ◽

2020 ◽

pp. 1-4

Author(s):

Carsten Obel ◽

Jørn Olsen ◽

Uffe Juul Jensen

Keyword(s):

Informed Consent ◽

Personal Data ◽

Health Data ◽

Epidemiologic Research ◽

Health Crisis ◽

Research Issues ◽

Data Analyses ◽

Computer Scientists ◽

Patient Groups ◽

Access To Data

In epidemiologic research we study why we get sick and how we get better. To do this we frequently need large datasets on exposure, diagnoses, treatment and more. We need data often classified as sensitive and regulated by law stating a need for informed consent. We argue that modern epidemiologic research often can be done on existing data without having informed consent and without violating basic ethic principles. We also argue for a timely and fair access to data in approved project. Modern encryption technics and methods of data analyses can reduce the risk of disclosure of personal data to a level close to what we have for anonymous data. If we allow open use of administrative health data and existing research data, we will be able to produce much more information to advance disease prevention, health promotion and treatment. Epidemiologists should collaborate more with computer scientists and patient groups in developing/implementing principles for ‘modern methods of data analyses’. Under a severe health crisis data are in high demand to provide the information needed to prevent deaths and diseases and often time does not permit requiring ‘informed consent’. Such a situation in now plying out worldwide under the Covid-19 pandemic.

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British Columbia’s Health Data Platform: Unleashing the Power of a Data Environment Commons for Health and Health System Improvement

International Journal for Population Data Science ◽

10.23889/ijpds.v5i5.1477 ◽

2020 ◽

Vol 5 (5) ◽

Author(s):

Shirley Wong ◽

Victoria Schuckel ◽

Simon Thompson ◽

David Ford ◽

Ronan Lyons ◽

...

Keyword(s):

Health Sector ◽

Data Access ◽

Health Data ◽

Decision Makers ◽

Security And Privacy ◽

Privacy And Security ◽

Data Accessibility ◽

Data Platform ◽

Access To Data ◽

Data Consumer

IntroductionThere is no power for change greater than a community discovering what it cares about.1 The Health Data Platform (HDP) will democratize British Columbia’s (population of approximately 4.6 million) health sector data by creating common enabling infrastructure that supports cross-organization analytics and research used by both decision makers and cademics. HDP will provide streamlined, proportionate processes that provide timelier access to data with increased transparency for the data consumer and provide shared data related services that elevate best practices by enabling consistency across data contributors, while maintaining continued stewardship of their data. HDP will be built in collaboration with Swansea University following an agile pragmatic approach starting with a minimum viable product. Objectives and ApproachBuild a data sharing environment that harnesses the data and the understanding and expertise about health data across academe, decision makers, and clinicians in the province by: Enabling a common harmonized approach across the sector on: Data stewardship Data access Data security and privacy Data management Data standards To: Enhance data consumer data access experience Increase process consistency and transparency Reduce burden of liberating data from a data source Build trust in the data and what it is telling us and therefore the decisions made Increase data accessibility safely and responsibly Working within the jurisdiction’s existing legislation, the Five Safes Privacy and Security Framework will be implemented, tailored to address the requirements of data contributors. ResultsThe minimum viable product will provide the necessary enabling infrastructure including governance to enable timelier access, safely to administrative data to a limited set of data consumers. The MVP will be expanded with another release planned for early 2021. Conclusion / ImplicationsCollaboration with Swansea University has enabled BC to accelerate its journey to increasing timelier access to data, safely and increasing the maturity of analytics by creating the enabling infrastructure that promotes collaboration and sharing of data and data approaches. 1 Margaret Wheatley

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