Oct 28 2024

Kristen Rosati Shares Insights on Artificial Intelligence Governance & Regulatory Trends at Arizona Healthcare Conference

Naomi Jorgensen
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At the Arizona Hospital and Healthcare Association Leadership Conference, Partner Kristen Rosati discussed tips for good governance of health care organizations’ use of artificial intelligence (AI) and explored the current state of regulation of AI. In her presentation, Kristen provided an overview of federal executive orders and regulations and offered a look ahead at potential future regulation. Kristen also discussed that states are stepping into the gap created by the lack of a comprehensive AI law at the federal level. From data privacy to transparency requirements for AI use, many states are already implementing their own regulations, shaping how the country approaches this technology as a whole. Her insights underscored the need for health care organizations to stay ahead of these regulatory requirements. A sought-after national...

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Oct 09 2024

Andy Gaona Provides Election Law Insight to Local Government Attorneys at National Conference

Naomi Jorgensen
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At the International Municipal Lawyers Association’s (IMLA) annual conference in Orlando, Andy Gaona recently contributed his election law expertise as part of a panel titled “Election Law in the Era of Hyperpartisanship.” Andy joined three other election law experts from around the nation to discuss the evolving legal landscape as the country gears up for the 2024 election. Drawing from firsthand experience representing the Arizona Secretary of State during both the 2020 and 2022 election cycles, Andy shared important lessons learned from those fiercely contested (and fiercely litigated) elections. He provided attendees with valuable insight into what he’s seen before, and what he expects for what lies ahead with another presidential election on the horizon. An experienced political, election, and constitutional law attorney, Andy has played a...

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Aug 01 2024

Amanda Coulter Demystifies Clinical Trial Agreements

Naomi Jorgensen
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During a recent Arizona Society of Healthcare Attorneys (AzSHA) webinar, Attorney Amanda Coulter shared her clinical trials legal expertise and provided a deep dive into clinical trial agreements (CTAs). This topic is essential to research sponsors, research personnel, and other healthcare stakeholders, helping them navigate complex regulations and legal contracts. Throughout the “Clinical Trials 101: What Health Care Lawyers Need to Know Now” webinar, Amanda spoke on the typical terms and issues encountered in CTAs, additional variations of research-related agreements and strategies for negotiations of research agreements.  Amanda also covered the main laws and regulations governing clinical trials. Amanda Coulter has extensive experience negotiating research agreements and developing research compliance policies and processes, template forms, and template agreements. She assists clients by reviewing and negotiating confidentiality agreements,...

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Jul 05 2024

Partner Kristen Rosati Breaks Down Big Data Deals for Academic Medical Centers

Naomi Jorgensen
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Kristen Rosati recently shared her expertise on “Big Data” arrangements with Academic Medical Centers (AMCs) at the National Association of College and University Attorneys (NACUA) Annual Conference in Columbus, Ohio. In the panel, “The Evolving Academic Medical Center: Addressing Regulatory, Strategic, and Financial Headwinds,” Kristen spoke about how the big data deals are driving revenue, supporting the development of artificial intelligence (AI) and other health care innovation, facilitating powerful research, creating rich data resources to improve health and health services and reduce the cost of health care, and bolstering public health activities. Despite Big Data’s positive influence, Kristen noted potential risks — breaches in data privacy and security and regulatory compliance chief among them. In these arrangements, the absence of thorough and thoughtful evaluation of the regulatory...

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Jul 03 2024

Kristen Rosati Provides Insight on Data De-Identification

Naomi Jorgensen
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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
May 29 2024

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

Naomi Jorgensen
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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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