Genomic Sequencing Capacity, Data Retention, and Personal Access to Raw Data in Europe

Narayanasamy, Shaman; Markina, Varvara; Thorogood, Adrian; Blazkova, Adriana; Shabani, Mahsa; Knoppers, Bartha Maria; Prainsack, Barbara; Koesters, Robert

doi:10.3389/fgene.2020.00303

Cited by 10 publications

(8 citation statements)

References 31 publications

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“…Individual health record access rights are being strengthened under data privacy laws such as the European General Data Protection Regulation 21 . Whether this extends to a patient’s right to access their raw sequence data is still uncertain.…”

Section: Culture Of Data Sharingmentioning

confidence: 99%

“…Whether this extends to a patient’s right to access their raw sequence data is still uncertain. Sequencing facilities in Europe report receiving a small number of such requests, which are handled on an ad hoc basis 21 . In North America, many clinical laboratories now have transparent consent processes to release raw data to clinicians or individuals.…”

Section: Culture Of Data Sharingmentioning

confidence: 99%

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Please give me a copy of my child’s raw genomic data

Chad

Szego

2021

npj Genom. Med.

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In this work, we explore whether raw genetic data generated during sequencing ought to be returned to a pediatric patient and/or their parents/guardians. We identify the principles used by various professional societies in their guidelines on the return of secondary findings and apply them to this new context. We conclude that since each situation is unique, decisions should be made on a case-by-case basis according to the best interests of the child.

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Section: Culture Of Data Sharingmentioning

confidence: 99%

Section: Culture Of Data Sharingmentioning

confidence: 99%

Please give me a copy of my child’s raw genomic data

Chad

Szego

2021

npj Genom. Med.

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“…Parental access appears to be an increasingly pressing question for healthcare institutions, clinicians and researchers. The prevalence of parental access requests has not been well-studied, though there is some preliminary empirical evidence of the prevalence of individual access requests generally (Narayanasamy et al, 2020 ). Patients and caregivers at pediatric institutions occasionally ask for their raw genomic data following WGS tests.…”

Section: Introductionmentioning

confidence: 99%

Parental Access to Children's Raw Genomic Data in Canada: Legal Rights and Professional Responsibility

et al. 2021

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Children with rare and common diseases now undergo whole genome sequencing (WGS) in clinical and research contexts. Parents sometimes request access to their child's raw genomic data, to pursue their own analyses or for onward sharing with health professionals and researchers. These requests raise legal, ethical, and practical issues for professionals and parents alike. The advent of widespread WGS in pediatrics occurs in a context where privacy and data protection law remains focused on giving individuals control-oriented rights with respect to their personal information. Acting in their child's stead and in their best interests, parents are generally the ones who will be exercising these informational rights on behalf of the child. In this paper, we map the contours of parental authority to access their child's raw genomic data. We consider three use cases: hospital-based researchers, healthcare professionals acting in a clinical-diagnostic capacity, and “pure” academic researchers at a public institution. Our research seeks to answer two principal questions: Do parents have a right of access to their child's raw WGS data? If so, what are the limits of this right? Primarily focused on the laws of Ontario, Canada's most populous province, with a secondary focus on Canada's three other most populous provinces (Quebec, British Columbia, and Alberta) and the European Union, our principal findings include (1) parents have a general right of access to information about their children, but that the access right is more capacious in the clinical context than in the research context; (2) the right of access extends to personal data in raw form; (3) a consideration of the best interests of the child may materially limit the legal rights of parents to access data about their child; (4) the ability to exercise rights of access are transferred from parents to children when they gain decision-making capacity in both the clinical and research contexts, but with more nuance in the former. With these findings in mind, we argue that professional guidelines, which are concerned with obligations to interpret and return results, may assist in furthering a child's best interests in the context of legal access rights. We conclude by crafting recommendations for healthcare professionals in the clinical and research contexts when faced with a parental request for a child's raw genomic data.

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“…As mentioned above, including South Korea, there are many countries [71][72][73] that have strong regulations against medical data being stored or being transmitted outside certified medical boundaries without strict authorization. Another unique characteristic of our proposed system is that we considered this by adopting the hash-data sync system.…”

Section: Discussionmentioning

confidence: 99%

DynamiChain: Development of Medical Blockchain Ecosystem Based on Dynamic Consent System

et al. 2021

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Although blockchain is acknowledged as one of the most important technologies to lead the fourth industrial revolution, major technical challenges regarding security breach and privacy issues remain. This issue is particularly sensitive in applied medical fields where personal health information is handled within the network. In addition, contemporary blockchain-converged solutions do not consider restricted medical data regulations that are still obstacles in many countries worldwide. This implies a crucial need for a system or solution that is suitable for the healthcare sector. Therefore, this article proposes the development of a dynamic consent medical blockchain system called DynamiChain, based on a ruleset management algorithm for handling health examination data. Moreover, medical blockchain-related studies were systematically reviewed to prove the novelty of DynamiChain. The proposed system was implemented in a scenario where the exercise management healthcare company provided health management services based on data obtained from the data provider’s hospital. The proposed research is envisioned to provide a widely compatible blockchain medical system that could be applied in future healthcare fields.

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Genomic Sequencing Capacity, Data Retention, and Personal Access to Raw Data in Europe

Cited by 10 publications

References 31 publications

Please give me a copy of my child’s raw genomic data

Please give me a copy of my child’s raw genomic data

Parental Access to Children's Raw Genomic Data in Canada: Legal Rights and Professional Responsibility

DynamiChain: Development of Medical Blockchain Ecosystem Based on Dynamic Consent System

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