Kristen Rosati

Kristen Rosati Presents Tips for Transactions Involving Big Data and Genomics at the American Health Law Association

Academic medical centers and hospital systems are increasingly being approached to share huge volumes of clinical data, biospecimens, and genetic sequencing data with a variety of partners, including pharmaceutical companies, biotech companies, AI and machine-learning companies, and other collaborative research partners. In a presentation at the American Health Law Association Academic Medical Centers and Teaching Hospitals Institute and the Physicians and Hospitals Law Institute in Orlando, Kristen Rosati explained how to manage and share health clinical and genomic data in a way that complies with HIPAA and state privacy laws. As part of her presentation, Kristen delved into special considerations for genomic data, including de-identification of genomic data, and dealing with evolving state genetic privacy laws. She also discussed the importance of implementing a good data...

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Kristen Rosati

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 Educates National Academies of Sciences, Engineering and Medicine about Patient Rights and Data Privacy

Looking to help oncology workshop attendees understand updates to patient privacy and data rights, the National Academies of Sciences, Engineering and Medicine turned to prominent “Big Data” and HIPAA compliance attorney Kristen Rosati. Kristen spoke during the two-day event: “Opportunities and Challenges for Using Digital Health Applications in Oncology: A Workshop.” Her presentation, “Legal Considerations – Patient Privacy and Data Security,” focused on ethical, security, governance, and payment issues with digital health applications and taught attendees about patients’ right of access to health information and new information blocking and interoperability rules. 2021 The Best Lawyers in America© and Phoenix Health Care “Lawyer of the Year,” Kristen has deep experience in data sharing for research and clinical integration initiatives, health information exchange, and clinical research privacy. She is...

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Kristen Rosati

Kristen Rosati Selected for AHLA’s Newest Fellowship Class

Leading health care attorney, Kristen Rosati, is one of seven elected as the American Health Law Association’s (AHLA) newest Fellows.  This honor recognizes career-long achievements, contributions and tenure with AHLA, and continuing service and leadership in the legal profession.  AHLA Fellows are ambassadors for the Association and serve as role models and mentors to current members. As a Past President, Member of the Board of Directors, and member of numerous AHLA programs planning committees, Kristen will be an outstanding addition to this esteemed group. “We truly had an impressive slate of candidates, which made the selection process a difficult one,” said AHLA President S. Craig Holden. “We greatly appreciate all those who expressed interest in serving our Association and welcome our newest class of AHLA leaders.” Considered...

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Kristen Rosati

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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ASU College of Health Solutions Lauds Mel Soliz’s Contributions to MDC Advisory Board

Melissa Soliz Informs Medical Practice Compliance Alert Readers about Interoperability and Clinical Notes

Under the new interoperability rules, health care providers should be prepared to share electronic health information — including clinical notes — with patients who request it. Medical Practice Compliance Alert recently turned to health care compliance attorney Melissa Soliz to help readers understand this requirement. Working closely with community health information exchanges, health care providers and health plans, Mel helps create compliance programs that meet new interoperability requirements. Industry outlets frequently turn to her for insight and she has been active in state and federal policy making on data privacy and health information exchange issues. Read the full article here. The article originally appeared in Medical Practice Compliance Alert, the authoritative leader on all things compliance....

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