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Jodi G. Daniel

Partner & CHS Managing Director | She/Her/Hers
Partner & CHS Managing Director | She/Her/Hers
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VCardLinkedInTwitter/X

Areas of Focus

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.

As one of the first digital health lawyers in the US and a former lead policymaker at the US Department of Health and Human Services, Jodi has a broad and unique understanding of the digital health market and cutting-edge health innovation--including artificial intelligence and machine learning, remote monitoring tools, EHRs, mobile health applications, digital therapeutics, health data platforms, and data analytics tools.  

Jodi counsels health technology companies, health care providers, health plans, life science companies and others on regulatory issues, including data access and use, privacy and security, interoperability, health information exchange, information blocking, telehealth, FDA oversight, federal reimbursement, and state law issues. She literally wrote the rules that govern data use and digital health, including HIPAA and interoperability rules, brings together regulatory issues from across government agencies, including the Office of the National Coordinator for Health IT (ONC), Centers for Medicare and Medicaid (CMS), Food and Drug Administration (FDA), and the Federal Trade Commission (FTC). 

In addition to advising on innovative products and services, Jodi frequently advocates for clients for policy changes before regulators. She also analyzes clients on compliance with new regulations and policies.

Career & Education

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    • 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
      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

    • 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
    • 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
    • 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
    • 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 | 8 min read | 12.20.24

End of Year Regulations on Interoperability

Federal policy efforts to advance health data exchange and interoperability are continuing to change rapidly. The latest changes are the publication of two final rules by the Assistant Secretary for Technology Policy/Office of the National Coordinator for Health Information Technology (ASTP/ONC) finalizing parts of the of the Health Data, Technology, and Interoperability (HTI-2) Proposed Rule. These rules adopt requirements regarding the Trusted Exchange Framework and Common Agreement (TEFCA) (HTI-2 Part 1), and create a new Information Blocking exception under Protecting Care Access (HTI-2 Part 2), on December 16th and 17th, respectively....

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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 | 8 min read | 12.20.24

End of Year Regulations on Interoperability

Federal policy efforts to advance health data exchange and interoperability are continuing to change rapidly. The latest changes are the publication of two final rules by the Assistant Secretary for Technology Policy/Office of the National Coordinator for Health Information Technology (ASTP/ONC) finalizing parts of the of the Health Data, Technology, and Interoperability (HTI-2) Proposed Rule. These rules adopt requirements regarding the Trusted Exchange Framework and Common Agreement (TEFCA) (HTI-2 Part 1), and create a new Information Blocking exception under Protecting Care Access (HTI-2 Part 2), on December 16th and 17th, respectively....

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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 | 8 min read | 12.20.24

End of Year Regulations on Interoperability

Federal policy efforts to advance health data exchange and interoperability are continuing to change rapidly. The latest changes are the publication of two final rules by the Assistant Secretary for Technology Policy/Office of the National Coordinator for Health Information Technology (ASTP/ONC) finalizing parts of the of the Health Data, Technology, and Interoperability (HTI-2) Proposed Rule. These rules adopt requirements regarding the Trusted Exchange Framework and Common Agreement (TEFCA) (HTI-2 Part 1), and create a new Information Blocking exception under Protecting Care Access (HTI-2 Part 2), on December 16th and 17th, respectively....

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Insights

Client Alert | 8 min read | 12.20.24

End of Year Regulations on Interoperability

Publication | 12.06.24

Proposed Rule On Protecting Bulk Sensitive Data And Its Impact On Health Care

Publication | 11.27.24

U.S. Department Of Health And Human Services Proposes Using Procurement Policy To Push Health Information Technology Standards

Blog Post | 11.26.24

RCE Issues Technical Guidance Governing TEFCA Exchange
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Practices

Jodi's Insights

Client Alert | 8 min read | 12.20.24

End of Year Regulations on Interoperability

Federal policy efforts to advance health data exchange and interoperability are continuing to change rapidly. The latest changes are the publication of two final rules by the Assistant Secretary for Technology Policy/Office of the National Coordinator for Health Information Technology (ASTP/ONC) finalizing parts of the of the Health Data, Technology, and Interoperability (HTI-2) Proposed Rule. These rules adopt requirements regarding the Trusted Exchange Framework and Common Agreement (TEFCA) (HTI-2 Part 1), and create a new Information Blocking exception under Protecting Care Access (HTI-2 Part 2), on December 16th and 17th, respectively....

View All Insights