Amanda Coulter Demystifies Clinical Trial Agreements

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,...

Read MoreRead More
Attorneys Kristen Rosati and Nate Kunz

Kristen Rosati & Nate Kunz Share Insights with the Arizona Society of Healthcare Attorneys on Online Tracking Tools for Health Care Organizations

After STAT Health News published an investigation into health care organizations' use of online tracking technologies, such as Meta Pixel, the Office for Civil Rights and the Federal Trade Commission launched their own investigations. The FTC has issued substantial fines, and now class actions are being filed across the U.S. The Arizona Society of Healthcare Attorneys hosted Kristen Rosati and Nate Kunz to provide insights on the regulatory and legal issues arising from health care organizations’ use of online tracking technologies. They explained online tracking compliance requirements for HIPAA, Federal Trade Commission regulations, and state data privacy laws. They also discussed best practices for protecting attorney-client privilege and the attorney work product while conducting internal investigations. Kristen, a past President and Fellow of the American Health Law...

Read MoreRead More
Karen Owens Advises Hospitals on Attracting Physician Leaders to Peer Review Committees

Karen Owens Blogs About Affordable Care Act Anti-Sex Discrimination for AzSHA

Following up to a recent presentation to the Arizona Society for Healthcare Attorneys (AzSHA),  Karen Owens provided a more in-depth examination of the anti-discrimination provisions in Section 1557 of the Affordable Care Act, including based on sex, limited English proficiency and disability. With major changes in the current regulations on sex discrimination expected and questions about the status of other parts of Section 1557, Karen’s blog helps readers understand the history and current status of Section 1557, major court decisions, practical realities for providers, and what may be next on the horizon. Karen, who serves on the AzSHA Board of Directors, represents health care systems, hospitals, clinics, and other providers in a variety of matters including quality management, medical staff credentialing and peer review, medical staff structures,...

Read MoreRead More

Melissa Soliz Updates Arizona Society of Healthcare Attorneys on Changes to Data Rules

Following a consequential year for health privacy and data rules, Mel Soliz updated the Arizona Society of Healthcare Attorneys about the upcoming changes to health data and privacy at a webinar. During the webinar “Got Data? : How the Health Data Rules are Changing,” Mel presented alongside Joanne Charles, principal corporate counsel, privacy and regulatory counsel at Microsoft, and Elliot Golding, a partner at Squire Patton Boggs. Together they covered HIPAA’s COVID-19 guidance, Information Blocking/Interoperability, 42 CFR Part 2, and the interplay between different state laws. Mel is frequently consulted for her deep knowledge of information blocking. She works closely with community health information exchanges, health care providers, and health plans to understand and create compliance programs for the Information Blocking Rule, as well as the CMS...

Read MoreRead More
Karen Owens Reappointed to Arizona Society of Healthcare Attorneys Board of Directors

Karen Owens Provides AzSHA with Affordable Care Act Anti-Sex Discrimination Overview

Karen Owens spoke at an Arizona Society for Healthcare Attorneys (AzSHA) meeting about the sex discrimination prohibitions in Section 1557 of the Affordable Care Act. Co-presenting with Trent Stechschulte, general counsel and compliance officer of Equitas Health in Ohio, Karen addressed the history and current status of Section 1557, along with major court decisions and practical realities for providers. Karen, who serves on the AzSHA Board of Directors, represents health care systems, hospitals, clinics, and other providers in a variety of matters including quality management, medical staff credentialing and peer review, medical staff structures, bylaws and confidentiality, as well as National Practitioner Data Bank, state professional board, and other government reporting. Review the full program summary here....

Read MoreRead More
Kristen Rosati

Kristen Rosati’s AHLA & AzSHA Presentations Highlight 2020 Health Care Law Developments

At the annual American Health Law Association (AHLA) Physicians and Hospitals Law Institute, Kristen Rosati educated industry professionals on the numerous legal developments 2020 brought to the health care industry. She also shared her “Year in Review” presentation at the Arizona Society of Healthcare Attorneys’ (AzSHA) February meeting. During these presentations, Kristen focused on significant legal updates resulting from the COVID-19 pandemic and a wave of regulations passed during the Trump Administration’s waning days. She provided health care lawyers with an overview of several topics related to the pandemic, including new legislation, the rapid rise of telemedicine, claims and developing immunity, and financial relief for providers and attendant risks. Her presentation also explored health care reform, including significant Supreme Court decisions and the status of the...

Read MoreRead More