Jodi G. Daniel
Overview
When health care and technology companies are developing or implementing innovative products and services to improve health care and wellness, they trust Jodi Daniel to navigate the complex and dynamic policy and regulatory environment to achieve their business goals. Jodi leverages her extensive experience in digital health and health data to provide strategic, practical advice to clients engaged in groundbreaking products and services that raise novel legal, policy and ethical questions.
Career & Education
- United States Department of Health and Human Services
Attorney-Advisor, Civil Rights Division, Office of General Counsel, 2000–2004
Senior Counsel for Health IT, Office of General Counsel, 2004–2005
Director, Office of Policy, Office of the National Coordinator for Health IT, 2005–2015
- United States Department of Health and Human Services
- Tufts University, B.A., cum laude, economics, community health, 1990
- Johns Hopkins University, M.P.H., health policy and management, 1996
- Georgetown University Law Center, J.D., magna cum laude, Order of the Coif, 1998
- District of Columbia
- New York
- National Academy of Medicine–Health Care Artificial Intelligence Code of Conduct; Steering Committee; July 2023–Present
- Academy Health, Committee on Advocacy and Public Policy Subcommittee on Health Data Policy 2023–Present
- Uniform Law Commission Telehealth Committee—Contributor, 2021–2022
- World Health Organization (WHO) Digital Health Roster of Experts, 2019–2022
- National Academy of Medicine/PCORI Workgroup: Building Stakeholder Demand for Health Data Sharing, Linkage, and Use, October 2018–2020
- National Academy of Medicine, Health Data Sharing to Support Better Outcomes, Research and Research Oversight Leaders Workgroup–2018–2019
- Asthma and Allergy Foundation of America Board of Directors, 2017–Present
- HIMSS Patient Generated Health Data Work Group, October 2015–October 2017
- Co–Chair, ABA Science and Technology Law Section, Healthcare Technology, 2016–2019
- Academy Health–Health Data Innovator Privacy and Security Advisory Committee, July 2016–August 2017
- Chesapeake Regional Information System for our Patients (CRISP) Data Use Committee, June 2016–June 2017
- National Medical Device Post–market Surveillance System Planning Board, 2014–2015
- HealtheWay Board of Directors, 2012–2015
- Medication Adherence Alliance Committee, Duke University, 2012–2015
- HHS Health IT Policy Committee and HHS Health IT Standards Committee, 2009–2015
- American Health Lawyers Association—Member
- State Alliance for e–Health, 2006–2011
- American Health Information Community, 2005–2008
- Medicare Governance Council, Quality Health Care Subcommittee, 2004–2005
Jodi is more than a subject matter expert and truly serves as a strategic thought partner for our business…Jodi is incredibly knowledgeable and provides sound, pragmatic advice…Jodi masterfully navigates the most complex legal issues. Her experience working at HHS has been invaluable…She's extremely knowledgeable in the digital health space generally.
— Chambers USA, 2022
Jodi's Insights
Client Alert | 23 min read | 10.31.24
Digital health companies, investors, and other healthcare organizations should follow policy developments with a strategic lens towards their market opportunities for key potential growth and risk mitigation. On a quarterly basis, we provide relevant legislative and regulatory updates on artificial intelligence (AI) and digital health policy developments.
Speaking Engagement | 09.23.24
"Advocacy Panel," 2024 DirectTrust Annual Conference, St. Louis, MO
Speaking Engagement | 09.13.24
Health Data Regulations - Privacy and Interoperability
Blog Post | 09.03.24
Representative Matters
- Provided regulatory counsel for a transaction for a global technology company negotiating a strategic partnership with a leading electronic health record (EHR) company to develop innovative products and tools for deployment across the health care market.
- Provided regulatory counseling and compliance guidance for a startup building a digital platform for clinical trials, including FDA regulatory interpretation, HIPAA and Common Rule compliance, and fraud and abuse prohibitions and exceptions.
- Advised life sciences and technology companies, as part of an international digital health coalition, on policies and legal issues related to software as a medical device (SAMD), software in a medical device (SiMD), AI and transparency for FDA and regulators globally.
- Advised an online health care marketplace company that provides patients with access to registered doctors and practices regarding HIPAA and state privacy law compliance and evolving telehealth laws.
- Provided strategic regulatory and product counseling for multiple innovative health technology companies ranging from startups to enterprise software platforms on advocacy of new information blocking legal prohibitions, including arranging meetings for clients with federal regulators to influence the regulations, and then on interpretation and compliance with interoperability, patient access APIs and information blocking.
- Provided privacy and security counseling to a technology company focused on women’s health solutions, including drafting its terms of use, reviewing its telemedicine contract, and identifying and crafting all privacy policies/procedures to be put in place.
- Advised a global technology company on various Medicare reimbursement and requirements for remote patient monitoring, including remote physiologic monitoring (RPM) and chronic care management (CCM) and for a wearable device.
- Provide strategic and legal advice to start-up health technology company combining consumer and social determinants of health data with clinical data to enable health care providers to target treatment to patients.
- Advise a multi-state health information exchange organization on data sharing and compliance with Part 2 rules regarding confidentiality of substance abuse records.
Jodi's Insights
Client Alert | 23 min read | 10.31.24
Digital health companies, investors, and other healthcare organizations should follow policy developments with a strategic lens towards their market opportunities for key potential growth and risk mitigation. On a quarterly basis, we provide relevant legislative and regulatory updates on artificial intelligence (AI) and digital health policy developments.
Speaking Engagement | 09.23.24
"Advocacy Panel," 2024 DirectTrust Annual Conference, St. Louis, MO
Speaking Engagement | 09.13.24
Health Data Regulations - Privacy and Interoperability
Blog Post | 09.03.24
Recognition
- National Law Journal: Healthcare Law Trailblazer, 2019, 2021
- Chambers USA: Band 3 for Healthcare—District of Columbia, 2024 | Band 3 for Privacy and Data Security: Healthcare–Nationwide, 2021–2024
- Financial Times: Top 10 Legal Practitioners, 2020
- Fierce Health IT: Top 10 Most Influential Women in Health IT, 2014
- HHS, National Coordinator Award, 2012, 2014
- HHS, Office for Civil Rights Director's Honor Award, 2002
- Center for Plain Language: Clearmark Award of Distinction, 2012
- Secretary's Commendation and Award for Distinguished Service, 2001, 2003, 2005, 2010
Jodi's Insights
Client Alert | 23 min read | 10.31.24
Digital health companies, investors, and other healthcare organizations should follow policy developments with a strategic lens towards their market opportunities for key potential growth and risk mitigation. On a quarterly basis, we provide relevant legislative and regulatory updates on artificial intelligence (AI) and digital health policy developments.
Speaking Engagement | 09.23.24
"Advocacy Panel," 2024 DirectTrust Annual Conference, St. Louis, MO
Speaking Engagement | 09.13.24
Health Data Regulations - Privacy and Interoperability
Blog Post | 09.03.24
Insights
Health Care Privacy: Closing the Gaps in HIPAA Regulation
|05.14.24
Privacy and Cybersecurity Outlook: The 2024 Landscape
- |
11.28.23
Crowell Health Solutions
How Will The Executive Order On Artificial Intelligence Impact Health Care?
|11.17.23
Health Affairs Forefront
Balancing The New Interoperability Rules With Existing Privacy Laws: Challenges for Payers
|10.01.20
AHLA Health Law Connection
Recent FTC Guidance On The Use Of Artificial Intelligence And Algorithms In The Age Of COVID-19
|09.01.20
The Computer & Internet Lawyer
Health Data Regulations - Privacy and Interoperability
|09.13.24
Accelerating the Data Transparency Movement to Understand the Costs and Impact of Care," AcademyHealth’s Health Data Leadership Institute, Washington, D.C.
|05.08.24
"Leveraging AI for Impact," Rock Health 2024 Spring Member Forum
|03.20.24
"High level overview of the business environment for healthtech companies in the US," HealthTech Investor Summit, Bruges, Belgium, 2023
|12.05.23
Biden Signs Sweeping Executive Order On AI, With Changes Coming For FDA And Healthcare
|10.30.23
Endpoints News
CMS Innovation Center Outlines Data Sharing Principles
|09.03.24
Crowell Health Solution’s Trends in Transformation
HHS Reorganizes ONC and Bolsters AI Leadership
|08.16.24
Crowell Health Solution’s Trends in Transformation
CMS opens Notice of Funding Opportunity (NOFO) for the Transforming Maternal Health (TMaH) Model
|07.30.24
Crowell Health Solution’s Trends in Transformation
- |
07.01.24
Crowell & Moring’s Health Law Blog
- |
06.27.24
Crowell Health Solution’s Trends in Transformation
AHRQ Outlines Principles and Recommendations to Advance Digital Healthcare Equity
|06.06.24
Crowell Health Solution’s Trends in Transformation
Taking a Closer Look at ONC’s AI Transparency Regulations
|05.03.24
Crowell Health Solution’s Trends in Transformation
Senate HELP Committee Ranking Member Issues Health Data Privacy Policy Recommendations
|04.18.24
Crowell Health Solution’s Trends in Transformation
ONC Releases an Updated Draft of Their 2024–2030 Federal Health IT Strategic Plan
|04.05.24
Crowell Health Solution’s Trends in Transformation
CMS Issues Guidance on HIPAA-Compliant Secure Texting Platforms
|04.03.24
Crowell Health Solution’s Trends in Transformation
Jodi's Insights
Client Alert | 23 min read | 10.31.24
Digital health companies, investors, and other healthcare organizations should follow policy developments with a strategic lens towards their market opportunities for key potential growth and risk mitigation. On a quarterly basis, we provide relevant legislative and regulatory updates on artificial intelligence (AI) and digital health policy developments.
Speaking Engagement | 09.23.24
"Advocacy Panel," 2024 DirectTrust Annual Conference, St. Louis, MO
Speaking Engagement | 09.13.24
Health Data Regulations - Privacy and Interoperability
Blog Post | 09.03.24