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

2020 ◽  
pp. 1-4
Author(s):  
Carsten Obel ◽  
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.

INFLUENCE OF OFFICE BLEACHING SYSTEMS ON THE RESISTANCE OF HARD TOOTH TISSUES

2020 ◽  
pp. 119-125
Author(s):  
Magsumova O.A. ◽  
Postnikov M.A. ◽  
Ryskina E.A. ◽  
Tkach T.M. ◽  
Polkanova V.A.
Keyword(s):  
Informed Consent ◽  
Oral Fluid ◽  
Personal Data ◽  
Acid Resistance ◽  
Non Invasive ◽  
Hard Tissues ◽  
Voluntary Informed Consent

One of the non-invasive methods for treating discoloration of hard tooth tissues is teeth whitening. The aim of this work is to assess the dynamics of changes in the acid resistance of enamel and hard tissues of teeth and the rate of its remineralization after the procedure of office teeth whitening. The study involved 123 patients aged 18 to 35 years with discoloration of various origins, with the color of hard tooth tissues on the Vita Classic A2 scale and darker. Before performing the office, teeth whitening procedure, all patients gave their written voluntary informed consent to participate in this study, as well as consent to the processing of personal data. Depending on the chosen method of office teeth whitening, patients were divided into 3 groups. The resistance of hard tooth tissues was judged based on the determination of TOER and CASRE tests. These indicators were determined at various times (5 days before the office teeth whitening procedure, 5 days after it, after 14, 30 days and 6 months). Regardless of the chosen whitening system, the office teeth whitening procedure is accompanied by a decrease in the enamel's resistance to acids and a decrease in the rate of its remineralization. The remineralizing function of oral fluid promotes the positive dynamics of the studied parameters after 14 days and after 30 days values increased due to the appointment of remineralizing therapy to all patients in 2 weeks after the teeth whitening procedure. After 6 months, all patients had high enamel resistance and the rate of its remineralization.

Regulations and Norms for Reuse of Residual Clinical Biospecimens and Health Data

2021 ◽  
pp. 019394592110292
Author(s):  
Elizabeth E. Umberfield ◽  
Sharon L. R. Kardia ◽  
Yun Jiang ◽  
Andrea K. Thomer ◽  
Marcelline R. Harris
Keyword(s):  
Informed Consent ◽  
Scoping Review ◽  
Real World ◽  
Genetic Information ◽  
Final Analysis ◽  
Health Data ◽  
Federal Regulations ◽  
Secondary Research ◽  
Domain Experts ◽  
Key Issues

Nurse scientists are increasingly interested in conducting secondary research using real world collections of biospecimens and health data. The purposes of this scoping review are to (a) identify federal regulations and norms that bear authority or give guidance over reuse of residual clinical biospecimens and health data, (b) summarize domain experts’ interpretations of permissions of such reuse, and (c) summarize key issues for interpreting regulations and norms. Final analysis included 25 manuscripts and 23 regulations and norms. This review illustrates contextual complexity for reusing residual clinical biospecimens and health data, and explores issues such as privacy, confidentiality, and deriving genetic information from biospecimens. Inconsistencies make it difficult to interpret, which regulations or norms apply, or if applicable regulations or norms are congruent. Tools are necessary to support consistent, expert-informed consent processes and downstream reuse of residual clinical biospecimens and health data by nurse scientists.

scholarly journals Artificial Intelligence in Biomedicine: A Legal Insight

BioTech ◽  
2021 ◽  
Vol 10 (3) ◽  
pp. 15
Author(s):  
Takis Vidalis
Keyword(s):  
Artificial Intelligence ◽  
Personal Data ◽  
Health Data ◽  
The Self ◽  
Data Handling ◽  
Direct Control ◽  
Eu Legislation ◽  
Attending Physicians ◽  
Self Learning ◽  
The Eu

The involvement of artificial intelligence in biomedicine promises better support for decision-making both in conventional and research medical practice. Yet two important issues emerge in relation to personal data handling, and the influence of AI on patient/doctor relationships. The development of AI algorithms presupposes extensive processing of big data in biobanks, for which procedures of compliance with data protection need to be ensured. This article addresses this problem in the framework of the EU legislation (GDPR) and explains the legal prerequisites pertinent to various categories of health data. Furthermore, the self-learning systems of AI may affect the fulfillment of medical duties, particularly if the attending physicians rely on unsupervised applications operating beyond their direct control. The article argues that the patient informed consent prerequisite plays a key role here, not only in conventional medical acts but also in clinical research procedures.

scholarly journals The funhouse mirror: the I in personalised healthcare

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.

DISORDERS OF PERIPHERAL CIRCULATION AMID CHRONIC OSTEOCHONDROSIS OF THE LUMBAR SPINE

Vestnik ◽  
2021 ◽  
pp. 24-28
Author(s):  
Р.С. Бегимбетова ◽  
Н.О. Бейсембинова ◽  
А.К. Кадырали ◽  
Г.М. Жолдасова ◽  
А. Бауржанкызы ◽  
...  
Keyword(s):  
Lumbar Spine ◽  
Informed Consent ◽  
Clinical Symptoms ◽  
Personal Data ◽  
Pain Syndrome ◽  
Peripheral Circulation ◽  
Research Protocol ◽  
Initial Visit ◽  
Continue Research ◽  
Inhibitory Reflex

Проведен анализ состояния периферического кровообращения у 28 мужчин, больных остеохондрозом поясничного отдела позвоночника, сопровождающегося люмбалгией с клинической симптоматикой нарушения периферического кровообращения нижних конечностей. Все больные, принимавшие участие в нашем исследовании, подписали информированное согласие на участие в программе и соглашение о неразглашении личных данных и протокола исследований. Критериями для анализа являлись изменения клинической симптоматики остеохондроза поясничного отдела позвоночника, обусловленной им люмбалгии и показателей оксиметрического исследования, которые были зафиксированы при первичном обращении и через 7 суток на фоне проводимого лечения и регрессии болевого синдрома. Таким образом, полученные результаты свидетельствовали о рефлекторном нарушении периферического кровообращения за счет развития патологического спинально-вазального тормозного рефлекса, обусловленного люмбалгией, которые восстанавливаются на фоне регрессии патологической импульсации в поясничном отделе позвоночника. Целесообразно продолжить исследования в этом направлении. The state of peripheral circulation in 28 men were analyzed, patients with osteochondrosis of the lumbar spine, accompanied by lumbodynia with clinical symptoms of impaired peripheral circulation of the lower extremities was carried out. All patients who took part in our study signed an informed consent to participate in the program and a non-disclosure agreement of personal data and research protocol. The criteria for the analysis were clinical symptoms of osteochondrosis of the lumbar spine caused by lumbodynia and indicators of oximetry studies, which were recorded during the initial visit and after 7 days amid treatment and regression of pain syndrome. Thus, the results indicated a reflex disorder of the peripheral circulation due to the development of a pathological spinal-vasal inhibitory reflex caused by lumbodynia, which is restored amid regression of pathological impulses in the lumbar spine. It is advisable to continue research in this direction.

scholarly journals Georeferenced data in epidemiologic research

2008 ◽  
Vol 13 (6) ◽  
pp. 1753-1766 ◽  
Author(s):  
Guilherme Loureiro Werneck
Keyword(s):  
Sensitivity Analysis ◽  
Spatial Clustering ◽  
Spatiotemporal Modeling ◽  
Epidemiologic Research ◽  
Research Issues ◽  
Correlation Studies ◽  
Analytical Approaches ◽  
Ecological Correlation ◽  
Further Development

This paper reviews some conceptual and practical issues regarding the application of georeferenced data in epidemiologic research. Starting with the disease mapping tradition of geographical medicine, topics such as types of georeferenced data, implications for data analysis, spatial autocorrelation and main analytical approaches are heuristically discussed, relying on examples from the epidemiologic literature, most of them concerning mapping disease distribution, detection of disease spatial clustering, evaluation of exposure in environmental health investigation and ecological correlation studies. As for concluding remarks, special topics that deserve further development, including the misuses of the concept of space in epidemiologic research, issues related to data quality and confidentiality, the role of epidemiologic designs for spatial research, sensitivity analysis and spatiotemporal modeling, are presented.

scholarly journals Privacy of Clinical Research Subjects: An Integrative Literature Review

2018 ◽  
Vol 14 (1) ◽  
pp. 33-48 ◽  
Author(s):  
Sanna-Maria Nurmi ◽  
Mari Kangasniemi ◽  
Arja Halkoaho ◽  
Anna-Maija Pietilä
Keyword(s):  
Clinical Research ◽  
Privacy Protection ◽  
Personal Data ◽  
Comparison Method ◽  
Health Data ◽  
The Body ◽  
Social Benefits ◽  
Theoretical Studies ◽  
Research Practice ◽  
Research Subjects

With changes in clinical research practice, the importance of a study-subject’s privacy and the confidentiality of their personal data is growing. However, the body of research is fragmented, and a synthesis of work in this area is lacking. Accordingly, an integrative review was performed, guided by Whittemore and Knafl’s work. Data from PubMed, Scopus, and CINAHL searches from January 2012 to February 2017 were analyzed via the constant comparison method. From 16 empirical and theoretical studies, six topical aspects were identified: the evolving nature of health data in clinical research, sharing of health data, the challenges of anonymizing data, collaboration among stakeholders, the complexity of regulation, and ethics-related tension between social benefits and privacy. Study subjects’ privacy is an increasingly important ethics principle for clinical research, and privacy protection is rendered even more challenging by changing research practice.

Regulatory Challenges of Data Mining Practices: The Case of the Never-ending Lifecycles of ‘Health Data’

2018 ◽  
Vol 25 (3) ◽  
pp. 284-307
Author(s):  
Giovanni Comandè ◽  
Giulia Schneider
Keyword(s):  
Data Mining ◽  
Data Protection ◽  
Personal Data ◽  
Health Data ◽  
General Level ◽  
General Data Protection Regulation ◽  
The Face ◽  
General Data ◽  
Level Of Analysis

Abstract Health data are the most special of the ‘special categories’ of data under Art. 9 of the General Data Protection Regulation (GDPR). The same Art. 9 GDPR prohibits, with broad exceptions, the processing of ‘data concerning health’. Our thesis is that, through data mining technologies, health data have progressively undergone a process of distancing from the healthcare sphere as far as the generation, the processing and the uses are concerned. The case study aims thus to test the endurance of the ‘special category’ of health data in the face of data mining technologies and the never-ending lifecycles of health data they feed. At a more general level of analysis, the case of health data shows that data mining techniques challenge core data protection notions, such as the distinction between sensitive and non-sensitive personal data, requiring a shift in terms of systemic perspectives that the GDPR only partly addresses.

scholarly journals General Public Views on Uses and Users of Administrative Health Data

2017 ◽  
Vol 1 (1) ◽  
Author(s):  
P. Alison Paprica ◽  
Michael Schull
Keyword(s):  
Private Sector ◽  
General Public ◽  
Personal Data ◽  
Health Data ◽  
General Information ◽  
Privacy And Security ◽  
Administrative Health Data ◽  
Potential Benefits ◽  
Public Views ◽  
Linked Administrative Health Data

ABSTRACTObjectivesHigh profile initiatives and reports highlight the potential benefits that could be realized by increasing access to health data, but do members of the general public share this view? The objective was to gain insight into the general public’s attitudes toward users and uses of administrative health data. ApproachIn fall 2015, four professionally-moderated focus groups with a total of 31 Ontario participants were conducted; two in Thunder Bay, two in Toronto. Participants were asked to review and comment on: general information about research based on linked administrative health data, a case study and models through which various users might use administrative health data. ResultsSupport for research based on linked administrative health data was strongest when people agreed with the purposes for which studies were conducted. The main concerns related to the security of personal data generally (e.g., Canada Revenue Agency hacking incidents were noted) and potentially inappropriate uses of health data, particularly by the private sector (e.g., strong reservations about studies done solely or primarily with a profit motive). Participants were reassured when provided with information about the process for removing or coding identifying information from health data, and about the oversight provided by the Information and Privacy Commissioner of Ontario. However, even when fully informed of privacy and security safeguards, participants still felt that risks unavoidably increase when there are more people and organizations accessing data. ConclusionsMembers of general public were generally supportive of research based on linked administrative health data but with conditions, particularly when the possibility of private sector research was discussed. Notably, and citing security concerns, focus group participants preferred models that had a limited number of individuals or organizations accessing data.

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