Kristen Rosati Reviews a Year of Health Law Updates for AHLA’s Annual Meeting

Kristen Rosati Publishes Article on Strategies for Complying with Revised NIH Policies in Harvard Data Science Review

The National Institute of Health’s (NIH) revised Data Management and Sharing Policy requires a data sharing plan for all NIH-funded research, triggering compliance challenges amid quickly evolving federal, state, and international privacy standards.  In a special issue of Harvard Data Science Review, Kristen Rosati published an article on adopting strategies for long-term compliance in light of changing laws. In her article, Kristen recommended strategic, long-term data sharing solutions, including using HIPAA’s expert determination method to de-identify data to minimize potential future disconnects in data de-identification standards. Additionally, in light of concerns about whether de-identification of data is sufficient protection of privacy, and in the absence of a federal law prohibiting the re-identification of individuals in de-identified data sets, she recommends utilizing contractual controls on the use...

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Kristen Rosati Co-Authors AHLA White Paper on AI in Healthcare

After planning and moderating a virtual convener session on artificial intelligence in healthcare for the American Health Law Association (AHLA), Kristen Rosati continues to help members understand AI’s applications for health care and dependence on big data strategies through a white paper. Kristen is a co-author of “Designing a Trusted Framework for the Application of AI in Health Care,” a white paper reflecting the opinions and perspectives of more than a dozen thought leaders from government and the health care industry. Topics addressed include data use, FDA regulation, liability, and transactional issues in AI. As one of the nation’s leading “Big Data” and HIPAA compliance attorneys, Kristen has extensive experience in data sharing for research and the development of artificial intelligence, as well as clinical integration, health...

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Kristen Rosati Reviews a Year of Health Law Updates for AHLA’s Annual Meeting

Kristen Rosati on Planning Committee for National Academies of Sciences, Engineering and Medicine Workshop on Data Sharing

The National Academies of Sciences, Engineering and Medicine invited Kristen Rosati to be on the planning committee for “Changing the Culture of Data Management and Sharing – a Workshop.” Kristen also moderated and spoke at a panel regarding legal barriers to data sharing and how to resolve them. The two-day virtual workshop explored challenges and opportunities for researchers, institutions and funders in establishing data management and sharing practices under the National Institute of Health’s new Data Management and Sharing Policy. Kristen’s presentation examined the legal and ethical issues that may prevent large-scale data sharing, including evolving laws on de-identification of health data. Kristen is considered one of the nation’s leading “Big Data” and HIPAA compliance attorneys. She offers deep experience in data sharing for research and clinical...

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Kristen Rosati Reviews a Year of Health Law Updates for AHLA’s Annual Meeting

Kristen Rosati Addresses “Big Data” Regulatory and Ethical Challenges in Research at University of California Symposium

Ethical and regulatory concerns arise when patient data is used for research. In a presentation for the University of California’s Ethics, Compliance and Audit Symposium, Kristen Rosati broke down common challenges when using “Big Data” in research, providing resources for researchers to understand de-identification practices and improve data governance.  Kristen explained the different compliance requirements for researchers using data gathered under various privacy laws, including HIPAA, 42 C.F.R. Part 2, the Common Rule, the California Consumer Privacy Act, and the European Union General Data Protection Regulation. She also shared best practices for good data governance in research, including prioritizing de-identified information, minimizing the amount of data used, implementing a data use agreement, and more.  Kristen is considered one of the nation’s leading “Big Data” and HIPAA compliance attorneys.  With extensive...

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Kristen Rosati on Planning Committee for National Academies of Sciences, Engineering and Medicine Workshop on Data Sharing

Kristen Rosati Shares Health Care Privacy Expertise with IAPP and AzHHA

Kristen Rosati shared her expertise on Big Data and health care privacy with a joint meeting of the International Association of Privacy Professionals and the Arizona Hospital and Healthcare Association on Sept. 29. Named the Best Lawyers® Phoenix Health Care Law “Lawyer of the Year” for 2014 and 2017, Kristen is one of the foremost HIPAA compliance attorneys in the nation. Her presentation shed light on a question facing many health care organizations today: how to share “Big Data” in an era of clinical integration. She explored statutory and regulatory privacy restrictions for data sharing arrangements including HIPAA, federal substance abuse treatment regulations, and state health information confidentiality laws....

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