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Firm News 17 results

Firm News | 3 min read | 02.15.24

Chambers Ranks Crowell Practices and Lawyers in 2024 Global Guide

Chambers and Partners has ranked 10 Crowell & Moring practice groups and 14 individual lawyers in the Chambers Global 2024 guide.

Firm News | 11.28.23

Crowell Health Solutions Examines the Adoption of Decentralized Clinical Trials and Provides Policy Recommendations

Washington – November 28, 2023: In recent years, rapid developments in digital health technologies has made it easier to collect, transfer, and store electronic data and has expanded the methods in which clinical trial sponsors may conduct research investigations, including through decentralized and hybrid clinical trials.
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Firm News | 4 min read | 07.19.23

Jodi Daniel Named to NAM’s AI Code of Conduct Project Steering Committee

Washington – July 19, 2023: Jodi G. Daniel, partner in Crowell & Moring’s Health Care Group and managing director of Crowell Health Solutions, has been named to the steering committee for the National Academy of Medicine (NAM)’s newly launched Artificial Intelligence Code of Conduct (AICC): Toward a Code of Conduct for Artificial Intelligence in Health, Health Care, and Biomedical Science Project.
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Client Alerts 83 results

Client Alert | 3 min read | 04.22.24

DOJ, FTC, and HHS Unveil Portal for Public Reporting on Anticompetitive and Monopolistic Practices in Health Care

In the latest sign that federal enforcers remain focused on increasing antitrust enforcement, last Thursday, the Justice Department (DOJ), Federal Trade Commission (FTC) and the Department of Health and Human Services (HHS) revealed an online portal, HealthyCompetition.gov, to encourage the public to submit reports on potential anticompetitive and monopolistic conduct in the healthcare sector.  The initiative seeks to address concerns that such behavior may affect healthcare affordability and quality, and employee wages. 
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Client Alert | 8 min read | 03.13.24

HHS Finalizes Significant Modifications Aligning Part 2 Regulations with HIPAA

On February 16, 2024, the U.S. Department of Health and Human Services (“HHS”) published a final rule (“Final Rule”) in the Federal Register modifying regulations at 42 C.F.R. part 2 (“Part 2”) governing the confidentiality of substance use disorder (“SUD”) records. The changes, which largely finalize those proposed in a notice of proposed rulemaking (“NPRM”), are intended to implement section 3221 of the Coronavirus Aid, Relief, and Economic Security (“CARES”) Act and more closely align Part 2 with privacy rules under the Health Insurance Portability and Accountability Act (“HIPAA”). Ultimately, the much-anticipated Final Rule relaxes some of Part 2’s very stringent requirements, which have historically limited the ability to include SUD data in electronic health information exchange and care coordination efforts. However, there may be more enforcement of Part 2 now that there can be civil enforcement that aligns with HIPAA. Compliance with the Final Rule is required by February 16, 2026.
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Client Alert | 7 min read | 01.31.24

CMS Issues Interoperability and Prior Authorization Final Rule

On January 17, 2024, the Centers for Medicare & Medicaid Services (CMS) issued the Interoperability and Prior Authorization Final Rule (Final Rule), which establishes requirements applicable to certain impacted payers which are intended to improve the electronic exchange of health information and prior authorization processes. The application programming interface (API) requirements will take effect January 1, 2027, while the operational provisions will take effect January 1, 2026. CMS has issued a helpful slide deck summarizing the Final Rule.
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Press Coverage 95 results

Publications 39 results

Events 17 results

Event | 05.08.24

2024 Health Data Leadership Institute

Crowell & Moring Partner and CHS Founder and Managing Director Jodi Daniel will be speaking at the 2024 Health Data Leadership Institute, taking place May 7-8 in Washington, DC. Her panel, "Accelerating the Data Transparency Movement to Understand the Costs and Impact of Care," will take place at 12:00 p.m. EST. 

Health Data Leadership Institute will convene individuals looking to gain a working knowledge of the current policy and regulatory landscape, where AI policies and practices are going (and how to reduce bias and harm), the impact of the Dobbs Decision on business operations and interoperability, and more.  

The Institute ensures opportunities for dialogue and small group discussion with practitioners in the field and peers who are experiencing similar challenges and opportunities. Attendees will hear from health policy experts, government program leaders, data users, entrepreneurs who have deep knowledge in data use, and data experts from technology and health care applications fields.

Event | 11.02.23, 4:00 PM EDT - 7:00 PM EDT

AI and Health Care: Perspectives from Policymakers and Movers in the Industry

Crowell invites you to an in-person roundtable discussion on Thursday, November 2nd at 4 PM EST, where we will dive into AI and health care from both the domestic and international perspectives. Consisting of two panels, the roundtable will bring representatives from the public and private sector to discuss current U.S. policy developments to regulate AI in healthcare settings, including a discussion of recent proposals from federal health agencies; recent actions by the United States and European Union and to govern use of AI in health care; companies’ current and future use of evolving health AI/ML technologies and the impact of pending regulations on AI technology; and how organizations can support ethical use and regulatory compliance when using health AI systems and technologies.

Event | 10.27.22, 11:00 AM EDT - 2:00 PM EDT

Crowell HealthTech Forum

The event will take place on October 27 from 3—6 PM ET and conclude with a networking reception on the Crowell terrace.
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Webinars 13 results

Webinar | 10.03.23, 12:00 PM EDT - 1:00 PM EDT

Approaches for Digital Health Organizations and Accountable Care Organizations to Develop Strong Compliance Programs

Our health care landscape is rapidly transforming. As the health care space has become more digitized and more reliant on technology than ever before, artificial intelligence (AI), telehealth services, data analysis, and medical devices have become drivers of our health care system. Likewise, value-based care is becoming increasingly popular among delivery systems, leaving accountable care organizations (ACOs) to adhere to changing federal compliance requirements. The burden falls on health care entities to remain up-to-date on how care is evolving as federal and state compliance regulations and privacy concerns continue to develop.
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Webinar | 12.13.22, 8:00 AM EST - 9:00 AM EST

What to Expect in Health Care in 2023: On the Hill, at Home and Abroad

The Crowell Health Solutions, Crowell & Moring Government Affairs Group and Crowell & Moring International (CMI) team invite you to attend a webinar on what to expect in health care in 2023 on Capitol Hill, in the U.S. and abroad, now that U.S. Mid-Term Elections are over. In particular, this webinar will focus on key issues such as drug pricing, health care supply chains, data privacy regulation, general and reproductive rights issues, telehealth and concerns that matter to U.S. and global healthcare companies. 
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Webinar | 03.22.22, 12:30 PM UTC - 4:00 PM UTC

AI/Machine Learning: Regulation, Development, and Real-World Performance Evaluation

On March 22, 2022 from 12:30 – 4:00 pm (EDT) the Duke-Margolis Center of Health Policy, with participation from the U.S. Food and Drug Administration (FDA) speakers and panelists, will hold a public webinar to spotlight updates and progress made since the release of FDA’s Artificial Intelligence/Machine Learning Action Plan in early 2021.
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Speaking Engagements 94 results

Speaking Engagement | December 4 - 6, 2023

HealthTech Investor Summit

Blog Posts 83 results

Blog Post | 04.18.24

Senate HELP Committee Ranking Member Issues Health Data Privacy Policy Recommendations

Crowell Health Solution’s Trends in Transformation

Blog Post | 04.05.24

ONC Releases an Updated Draft of Their 2024–2030 Federal Health IT Strategic Plan

Crowell Health Solution’s Trends in Transformation

Blog Post | 04.03.24

CMS Issues Guidance on HIPAA-Compliant Secure Texting Platforms

Crowell Health Solution’s Trends in Transformation

Podcasts 4 results

Podcast | 02.23.24

Payers, Providers, and Patients – Oh My!: Enabling Widespread Adoption of Decentralized Clinical Trials

In this episode, hosts Payal Nanavati, Jodi Daniel, and Cara Tenenbaum talk to Ben Moscovitch, Devon Adams, and Noah Goodson about recent policy developments on decentralized clinical trials (DCTs). They also discuss the Crowell Health Solutions’ white paper on DCTs, which issues to federal agencies a number of policy recommendations to advance DCT adoption and increase clinical trial diversity.
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Podcast | 12.08.21

Payers, Providers, and Patients – Oh My!: The New World of Health Data Interoperability

In this episode, hosts Payal Nanavati and Joe Records talk to Jodi Daniel and Savanna Williams about the latest developments in interoperability, including challenges of implementing recent CMS and ONC regulations and expectations about potential enforcement of these rules. 
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Podcast | 01.14.20

Payers, Providers, and Patients – Oh My!: Digital Health Innovation

In this episode, hosts Payal Nanavati and Joe Records sit down with Jodi Daniel and Ambassador Robert Holleyman to discuss how regulators—across the U.S. and the rest of the world—can overcome the challenges of regulating emerging digital health technologies without stifling innovation. Payers, Providers, and Patients – Oh My! Is Crowell & Moring’s health care podcast, discussing legal and regulatory issues that affect health care entities’ in-house counsel, executives, and investors.
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