The Effect of the General Data Protection Regulation on Medical Research

Rumbold, John; Pierscionek, Barbara K.

doi:10.2196/jmir.7108

Cited by 112 publications

(75 citation statements)

References 15 publications

(13 reference statements)

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“…Once an app has been optimized to maximize patient empowerment, several additional barriers need to be addressed in order to obtain full adoption of mHealth tools in clinical practice. Mobile apps collecting personal data have to comply with privacy regulations—General Data Protection Regulation (GDPR)—as well as with local laws. Strikingly, an analysis performed in 2014 showed that 30.5% of mobile health apps have included a privacy policy document and most require a high level of literacy .…”

Section: Discussionmentioning

confidence: 99%

Mobile health tools for the management of chronic respiratory diseases

Sleurs

Seys

Bousquet

et al. 2019

Allergy

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Background: The market of mobile health (mHealth) technology is rapidly evolving, making new mobile technologies potentially available for healthcare systems. Patient empowerment through self-monitoring of symptoms, shared decision making with the physician, and easily accessible education are important features extending the reach of mHealth technology beyond traditional care.Methods: Two digital distribution platforms (Apple App Store and Google Play Store) were searched for currently available mobile applications (apps) for patients with chronic respiratory diseases (CRDs). A new index (score ranging from 0 to 10) was developed to assess the potential of apps as a tool to empower patients through mobile technology (based on self-monitoring, personalized feedback, and patient education app features). Results:One hundred and twelve apps were retained for analysis and could be classified in 5 categories: Asthma (n = 71), COPD (n = 15), Asthma and COPD (n = 15), Rhinitis and Asthma (n = 5), and Rhinosinusitis (n = 6). Eighty percent were developed by medical technology companies compared to 18% by medical doctors and 2% by pharmaceutical companies. Two-thirds of apps allow disease self-monitoring, whereas over half of apps provide patient feedback through graphs. Sixty percent of apps contain easily accessible patient education material.Only three percent of apps reach a score of ≥7 on the newly designed patient empowerment index. Conclusions:A variety of apps are available for patients with CRDs of which only few were developed by or jointly with medical doctors. The majority of these apps include self-monitoring tools, but only few also provide personalized feedback, which is needed to adopt these apps into daily care. K E Y W O R D Sallergic rhinitis, asthma, chronic rhinosinusitis, mobile application, patient empowerment Sleurs and Seys shared first authors.Sleurs and Seys equally contributed to the manuscript.

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Section: Discussionmentioning

confidence: 99%

Mobile health tools for the management of chronic respiratory diseases

Sleurs

Seys

Bousquet

et al. 2019

Allergy

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“…Our findings show that dfDNC (RQ2) enhanced the care management of the digital literate care recipients, the feelings of safety among informal caregivers, and efficiency of organization by the formal caregivers, which are all basic ingredients of good quality of care [20]. Before actually using an e-tool, it is important to (RQ3) consider the several barriers and facilitators of success when implementing it into homecare organizations, such as anticipating on changes in data protection legislation [21]. Finally, digital networked communication may enhance the linkages in the triangle of client, informal caregiver and professional caregiver, and increase peace of mind amongst all users.…”

Section: To Concludementioning

confidence: 94%

A Groupware Tool to Facilitate Caregiving for Home-Dwelling Frail Older Persons in the Netherlands: Mixed-Methods Study (Preprint)

Breebaart¹,

Groenou²

2018

Preprint

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“…The General Data Protection Regulation aims at increasing individuals’ control of personal data, including research data, and is expected to place higher demands on biomedical researchers in European countries with regard to data access. The Regulation states, for instance, that research participants should ‘receive their information in an appropriate form without hindrance’ to improve data portability 31. In practice, however, it will not always be easy for research groups to provide research participants with individual research data, as it may require effort to present data ‘in an appropriate form’.…”

Section: Other Reasons To Disclose Ad Biomarkersmentioning

confidence: 99%

On the personal utility of Alzheimer’s disease-related biomarker testing in the research context

Bunnik

Richard²,

Milne

et al. 2018

J Med Ethics

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Many healthy volunteers choose to take part in Alzheimer's disease (AD) prevention studies because they want to know whether they will develop dementia-and what they can do to reduce their risk-and are therefore interested in learning the results of AD biomarker tests. Proponents of AD biomarker disclosure often refer to the personal utility of AD biomarkers, claiming that research participants will be able to use AD biomarker information for personal purposes, such as planning ahead or making important life decisions. In this paper, the claim that AD biomarkers have personal utility for asymptomatic individuals is critically assessed. It demonstrates that in the absence of clinical validity, AD biomarkers cannot have personal utility and do not serve research participants' autonomy. Over the next few years, many research groups will be confronted with participants' preferences to learn the results of AD biomarker tests. When researchers choose to make results available upon explicit request, they should ensure adequate information provision and education, notably on the uncertain clinical significance of AD biomarker information. Routine disclosure of AD biomarkers to cognitively unimpaired individuals in research settings cannot be justified with an appeal to the personal utility of AD biomarker information.

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The Effect of the General Data Protection Regulation on Medical Research

Cited by 112 publications

References 15 publications

Mobile health tools for the management of chronic respiratory diseases

Mobile health tools for the management of chronic respiratory diseases

A Groupware Tool to Facilitate Caregiving for Home-Dwelling Frail Older Persons in the Netherlands: Mixed-Methods Study (Preprint)

On the personal utility of Alzheimer’s disease-related biomarker testing in the research context

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