A5005759906- Ethics in Clinical Research
- Privacy, Security, and Data Protection
- Health Systems, Economic Evaluations, Quality of Life
- BRCA gene mutations in cancer
- Privacy-Preserving Technologies in Data
- Genomics and Rare Diseases
- Lipoproteins and Cardiovascular Health
- Ethics and Social Impacts of AI
- Spectroscopy and Quantum Chemical Studies
- Artificial Intelligence in Healthcare and Education
- COVID-19 Digital Contact Tracing
- Statistical Methods in Clinical Trials
- Intellectual Property and Patents
- Pharmacogenetics and Drug Metabolism
- Pharmaceutical Economics and Policy
- Biomedical Ethics and Regulation
- Health and Medical Research Impacts
- Fluid Dynamics and Turbulent Flows
- Mobile Health and mHealth Applications
- Law, AI, and Intellectual Property
- Patient Dignity and Privacy
- Ethics in Business and Education
- Mental Health and Patient Involvement
- Biosimilars and Bioanalytical Methods
- Advancements in Semiconductor Devices and Circuit Design
Duke University
2021-2025
Center for Neuro-Oncology
2021-2024
Harvard Pilgrim Health Care
2019-2023
Harvard University
2019-2023
Digital Research Alliance of Canada
2023
Ohio University
2022-2023
Creative Commons
2022
Michigan Public Health Institute
2022
Robert Wood Johnson Foundation
2022
Future of Privacy Forum
2021
The Global Alliance for Genomics and Health (GA4GH) aims to accelerate biomedical advances by enabling the responsible sharing of clinical genomic data through both harmonized aggregation federated approaches. decreasing cost sequencing (along with other genome-wide molecular assays) increasing evidence its utility will soon drive generation sequence from tens millions humans, levels diversity. In this perspective, we present GA4GH strategies addressing major challenges revolution. We...
Artificial intelligence (AI) and machine learning (ML) technology design development continues to be rapid, despite major limitations in its current form as a practice discipline address all sociohumanitarian issues complexities. From these emerges an imperative strengthen AI ML literacy underserved communities build more diverse workforce engaged health research. has the potential account for assess variety of factors that contribute disease improve prevention, diagnosis, therapy. Here, we...
<sec> <title>BACKGROUND</title> Biomedical innovation is often dependent on individuals’ expressed willingness to donate health data generated in real world settings (real-world or RWD). Yet, unresolved ethical, legal, and social implications (ELSI) concerns (i.e., genetic privacy nondiscrimination) exist alongside aging populations’ share RWD with researchers. </sec> <title>OBJECTIVE</title> To describe an today post-mortem researchers summarize their ELSI-related concerns....
Abstract Point‐of‐care trials, an approach to trial design that assesses medical product effectiveness while fully integrating research and care, represent a promising opportunity generate practically relevant evidence efficiently for priority disease areas. However, this presents unique considerations appropriate ethical informed consent. As point‐of‐care trials evolve, it will be important examine consent through the lens of their supporting technology, clinicians who are responsible...
International harmonization of real-world data and evidence (RWD/E) standards is a goal among data/real-world policy stakeholders. The Duke-Robert J. Margolis Institute for Health Policy developed an online 'International Harmonization RWE Standards Dashboard' to provide timely updates around these goals. Guidance industry (draft final) related literature available by medical product regulators globally was sought and, where needed, translated into English language using certified...
<sec> <title>UNSTRUCTURED</title> The role and use of race within health-related artificial intelligence machine learning (AI/ML) models has sparked increasing attention controversy. Despite the complexity breadth related issues, a robust holistic framework to guide stakeholders in their examination resolution remains lacking. This perspective provides broad-based, systematic, cross-cutting landscape analysis race-related challenges, structured around AI/ML lifecycle framed through “points...
Abstract Objectives Artificial intelligence (AI) proceeds through an iterative and evaluative process of development, use, refinement which may be characterized as a lifecycle. Within this context, stakeholders can vary in their interests perceptions the ethical issues associated with rapidly evolving technology ways that fail to identify avert adverse outcomes. Identifying throughout AI lifecycle systematic manner facilitate better-informed deliberation. Materials Methods We analyzed...
This Viewpoint discusses privacy and discrimination issues raised when direct-to-consumer (DTC) genetic testing companies give law enforcement agencies access to their data, gaps in nondiscrimination HIPAA regulations protecting consumers of DTC more generally.
Direct-to-consumer genetic testing (DTC-GT) companies are engaging health consumers in unprecedented ways and leveraging the information they collect to further engage companies. This has produced controversy about DTC-GT consumer expectations, standards, perceptions of privacy. In this commentary, we highlight recent events involving privacy that followed those discuss studies have explored concerns We company standards upholding general accessibility terms use agreements policies written...
Background: There is a lack of African American (AA) community engagement in genomic medicine research.Recent popular interest the experience AAs, such as that Henrietta Lacks, has perhaps prompted research on how AA nurses can provide strategies to better engage communities research.Methods: The authors conducted one-on-one semi-structured interviews with 11 National Black Nurses Association (NBNA) chapter leaders from 8 different US states, representing 782 NBNA members.Results: Our...
Cardiovascular disease (CVD) is the leading cause of death in United States (US), with familial hypercholesterolemia (FH) being a major inherited and genetic risk factor for premature CVD atherosclerosis. Genetic testing has helped patients providers confirm presence known pathogenic likely variations FH-associated genes. Key organizations, such as Centers Disease Control Prevention (CDC), American Heart Association (AHA), FH Foundation, National Lipid (NLA), have recognized clinical utility...
<ns3:p>Genomic science is increasingly central to the provision of health care. Producing and applying robust genomics knowledge a complex endeavour in which no single individual, profession, discipline or community holds all answers. Engagement involvement diverse stakeholders can support alignment societal scientific interests, understandings perspectives promises better fairer outcomes. In this context we argue for F.A.I.R.E.R. data use that Findable, Accessible, Interoperable,...
Importance The conditions required for health record data sources to accurately assess treatment effectiveness remain unclear. Emulation of randomized clinical trials (RCTs) with and subsequent calibration the results can help elucidate this. Objective To pilot an emulation KEYNOTE-189 RCT using a commercially available electronic (EHR) source. Design, Setting, Participants This retrospective cohort study used EHR database spanning from April 2007 February 2023. Follow-up began on initiation...
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Employers in the United States (US) increasingly offer personalized wellness products as a workplace benefit. In doing so, those employers must be cognizant of not only US law but also European Union (EU) to extent that EU applies immigrants or guest workers US. To programs are implemented either public health employment contexts within and/or EU, sponsors these can partner with direct-to-consumer (DTC) genetic testing companies and other digital generate, collect, process sensitive...
Real-world data privacy is a complex yet underexplored topic. To date, few studies have reported adult perspectives around real-world and willingness to share with researchers.Relevant survey items were identified in the literature, adapted pilot tested among small convenience sample, finalized for distribution. The was distributed electronically April 2021 adults (≥18 years of age) registered ResearchMatch (www.researchmatch.org). Microsoft Excel used assess descriptive statistics across...
Background: Real-world data (RWD) privacy is an increasingly complex topic within the scope of personalized medicine, as it implicates several sources data. Objective: To assess how privacy-related experiences, when adjusted for age and education level, may shape adult research participants’ willingness to share various real-world with researchers. Methods: An electronic survey was conducted in April 2021 among adults (≥18 years age) registered ResearchMatch, a national health registry....