Kristen Rosati Provides Insight on Data De-Identification

Partner Kristen Rosati recently addressed the HIPAA standards for de-identification of data at The American Health Law Association (AHLA) annual meeting in Washington, D.C. During the "De-Mystifying De-Identification" panel discussion, Kristen and her co-speakers discussed the challenges and solutions associated with new HIPAA, other federal laws, U.S. state privacy laws, and the EU GDPR. Because of the importance of de-identified data to research, innovation (such as the development of AI), and health care delivery improvement, a good understanding of data de-identification is key to the health care industry. A sought-after national speaker, Kristen has been active in national health care policy and served as past President (2013-2014) and Fellow of the American Health Law Association (AHLA), the nation’s largest health care legal organization. She was recently recognized...

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Mel Soliz BCBS

Mel Soliz Prepares Blue Cross Blue Shield Association (BCBSA) Conference Goers for CMS Expanded Interoperability Mandates

The deadline for compliance with CMS’s expanded application programming interface (API) requirements is closer than you think. Partner Mel Soliz was invited to the esteemed BCBSA 2024 Law, Audit, Compliance & Ethics Conference to discuss the new API requirements and significant implementation challenges. Mel covered what impacted payers need to achieve over the next three years to implement an expanded Patient Access API and a new Provider Access API, Payer-to-Payer API and Prior Authorization API. Mel’s regulatory practice focuses on compliance with data privacy, access and interoperability laws (such as the Information Blocking Rule and CMS interoperability mandates as well as state mini-interoperability laws), health IT/technology service contracting, and health information networks/exchanges (including national interoperability frameworks such as TEFCA, Carequality, CommonWell, DURSA, and DxF). She regularly...

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Kristen Rosati Moderates Panel on AI Governance in Health Care

As artificial intelligence (AI) is increasingly utilized by the health care industry, new legal challenges are emerging. The American Health Law Association (AHLA) invited Partner Kristen Rosati to their Chicago conference to moderate a panel discussion exploring the governance structures needed to handle the complexities of AI in health care. Kristen’s opening remarks spoke to how AI’s growing presence is contributing to a fundamental shift in health care. She noted how easily organizations can get swept off their feet by the hype around AI applications. Health care organizations’ aim should not be the adoption of AI, but rather adopting AI in particular use cases to achieve progress in better patient care, improved population health, reduced cost of care, and better patient and clinician experience. Kristen and the...

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Kristen Rosati Talks Data Strategy for Digital Health Companies at the American Telemedicine Association Annual Meeting

“Big Data” attorney Kristen Rosati spoke on a panel at the American Telemedicine Association’s Annual Conference, Nexus, on the pros and cons of moving direct-to-consumer functions within the HIPAA-regulated functions of a company. In the presentation, “The Cutting Edge of Digital Health Privacy Law,” Kristen spoke to the big shift in digital health companies’ approach to HIPAA compliance. While many digital health companies tried to avoid HIPAA in the past, the explosion of state consumer data privacy laws have started to change that calculus because all state laws to date have HIPAA exemptions. Kristen explained that complying with HIPAA reduces the complexity of compliance processes, and offers exemption from the Federal Trade Commission (FTC) health breach reporting rule, which has more stringent reporting obligations than HIPAA. Kristen...

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Attorney Kristen Rosati Guides Brain Health Nexus Leaders Through ‘Big Data’ Legal Nuances

Brain Health Nexus recently tapped Coppersmith Brockelman Attorney Kristen Rosati, one of the nation’s top lawyers on “big data,” to share legal insights on the evolving challenges in data sharing during a governance workshop in Washington, D.C. The workshop was part of a new effort to develop a “Brain Health Index,” modeled after the Heart Health Index, which will define and quantify brain health based on core domains of brain function using an information technology framework that collects, integrates and models global data. Ultimately, this type of index can help detect signs or likelihood of brain disease earlier, allowing patients to work with their providers to take preventative measures. Kristen weighed in on the data-sharing requirements for the Brain Health Index and provided insights into key...

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Kristen Rosati

Kristen Rosati Moderates Panel for the National Academies of Sciences, Engineering and Medicine on Data Sharing in Cancer Research

As a national expert on data sharing, Kristen Rosati was called to moderate a high-profile panel of experts during a session of the National Academies of Sciences, Engineering and Medicine’s workshop on Optimizing Public-Private Partnerships for Clinical Cancer Research. As a member of the planning committee, Kristen, along with Otis Brawley of Johns Hopkins University, facilitated the panel on Enhancing Data Sharing for Public-Private Partnerships for Clinical Cancer Research. The session provided insights on the roles various groups play in the process, including from government, research institutions, patients, sponsors, funders, and publications.  Panelists included members from NIH, Harvard University, the Leukemia and Lymphoma Society, Invitae/Ciitizen, Eli Lilly, Cancer Research UK/Cancer Research Horizons, the Journal of the American Medical Association, and the New England Journal of Medicine. Kristen also...

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