Who’s on third? Regulation of third-party genetic interpretation services

Guerrini, Christi J.; Wagner, Jennifer K.; Nelson, Sarah C.; Javitt, Gail; McGuire, Amy L.

doi:10.1038/s41436-019-0627-6

Cited by 33 publications

(25 citation statements)

References 20 publications

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“…What about greater regulation of third-party interpretation services, especially when it comes to children's genetic data? (Guerrini et al, 2020)…”

Section: Leveraging Professional Expertise With Access Rightsmentioning

confidence: 99%

“…Parents may seek access to their child's genomic data for a number of reasons: to seek a second medical opinion about the child's condition, to inform the parents' health or reproductive choices, to share data with a health research project or repository, or to analyze the data themselves to better understand health conditions affecting their child or entire family (though, importantly, their motivation may be unknown in the context of legal access requests). We expect parental access to become more pressing in coming years as a result of three trends: (1) patients are taking a greater role in directing their care and managing their data 1 , (2) sequencing of children is expanding, particularly to new clinical and newborn screening contexts 2 , and (3) a growing ecosystem of third party interpretation services and data sharing platforms are emerging directed toward patients (Capaci et al, 2020;Guerrini et al, 2020).…”

Section: Introductionmentioning

confidence: 99%

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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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“…What about greater regulation of third-party interpretation services, especially when it comes to children's genetic data? (Guerrini et al, 2020)…”

Section: Leveraging Professional Expertise With Access Rightsmentioning

confidence: 99%

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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“…13 Some patients may make use of raw genetic data to generate nutrigenomics-related information that was not part of the original test results, as various software is available online to perform this kind of analysis. 89 HCPs should follow the same principles indicated in Steps 1 and 2 when reviewing genetic results brought by the patient. Box 3 provides a case study overview of Step 3.…”

Section: Reviewing Nutrigenomics Testsmentioning

confidence: 99%

Guiding Global Best Practice in Personalized Nutrition Based on Genetics: The Development of a Nutrigenomics Care Map

Horne¹,

Nielsen²,

Madill³

et al. 2022

Journal of the Academy of Nutrition and Dietetics

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“…For example, in the absence of congressional action, the Food and Drug Administration (FDA) has performed mental gymnastics to contort direct-to-consumer genomic interpretation and predictive algorithms as “medical devices” in order to act within the boundaries of its authority specifically defined in the Food Drug and Cosmetic Act (FD&C Act). 27 Similarly, in the area of wearables and other “internet of things” consumer products, the Consumer Product Safety Commission (CPSC) has a limited focus on protecting consumers from physical injuries only. 28 In this extraordinary and essential “first responder” role, the FTC should be brave and bold, taking swift and decisive actions that promote businesses and protect consumers.…”

Section: Ftc Structure and Consumer Protection Authoritymentioning

confidence: 99%

The Federal Trade Commission and Consumer Protections for Mobile Health Apps

Wagner¹

2020

J. Law. Med. Ethics

Self Cite

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The Federal Trade Commission (FTC) has an important role to play in the governmental oversight of mobile health apps, ensuring consumer protections from unfair and deceptive trade practices and curtailing anti-competitive methods. The FTC’s consumer protection structure and authority is outlined before reviewing the recent FTC enforcement activities taken on behalf of consumers and against developers of mhealth apps. The article concludes with identification of some challenges for the FTC and modest recommendations for strengthening the consumer protections it provides.

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Who’s on third? Regulation of third-party genetic interpretation services

Cited by 33 publications

References 20 publications

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

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

Guiding Global Best Practice in Personalized Nutrition Based on Genetics: The Development of a Nutrigenomics Care Map

The Federal Trade Commission and Consumer Protections for Mobile Health Apps

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