P.O. Box 117625
Gainesville, FL 32611-7625
United States
University of Florida Levin College of Law
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health information technology, privacy, data ownership, HIPAA, Common Rule, HITECH Act
Clinical Decision Support (CDS) Software, Food and Drug Administration (FDA), Software as a Medical Device (SaMD), product liability, artificial intelligence
precision medicine, citizen science, data commons, privacy, interoperable health data resources
genetics, return of results, First Amendment, direct-to-consumer genetic testing, CLIA
drug safety, torts, preemption, Wyeth v. Levine, Food & Drug Administration, FDA, genetic tests, drug regulation, clinical trial, health data network, Food & Drug Administration Amendments Act, FDAAA, pharmacogenomics
Clinical Decision Support Software, Software as a Medical Device, FDA, Artificial Intelligence, Machine Learning
DNA, genetics, genomics, GINA, HIPAA, privacy
HITECH Act, HIPAA Privacy Rule, consent waiver, privacy waiver, health IT, informational privacy
privacy, food and drug law, section 505(o)(3), postmarketing observational studies, HIPAA privacy Rule, Common Rule
FDA, gene sequencing, high-throughout sequencing, Part 812, IDE, research
Privacy, Sentinel System, health database, Nationwide Health Information Network (NHIN), public health, infrastructure regulation, infrastructure financing, Food and Drug Administration Amendments Act of 2007 (FDAAA), HIPAA Privacy Rule, privacy authorization, informed consent, drug safety, FDA
Citizen Science, Common Rule, FDA, IRB, IRBs, Mobile Devices, NIH, Research Ethics
Genetic Information Nondiscrimination Act, HIPAA Privacy Rule, genomic data, data privacy, data transparency, civil rights, genetic discrimination
Common Rule, Human-subject protections, Common Rule ANPRM, administrative law
Privacy, HIPAA, Preemption, Public Health, Interoperable Health Data Networks, Health IT
Reclassification, Genetics, Bioethics, Biolaw, Fifty-State Survey, Medical Malpractice, Torts
AI/ML medical software, clinical decision support (CDS) tools, data privacy, bias, HIPAA Privacy Rule, health equity
Transparency, Health Insurance, Contracts, Clinical Trials, ERISA, Antitrust
FDA, Sentinel network, FDAAA, health information technology, data network, health database, governance, HIPAA, privacy, data access, data use rights, public-private partnership
Data privacy, individual access rights, HIPAA Privacy Rule, citizen science, FDA research regulations
Data Privacy, Return of Results, Genomics, Biomedical Research, Civil RIghts, HIPAA, GINA, CLIA laboratory regulations