Jodi G. Daniel

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Jodi Daniel is a partner in Crowell & Moring's Washington, D.C. office and a member of the firm's Health Care Group, where she provides strategic advice to clients navigating the legal and regulatory environments related to technology in the health care sector. Jodi is the former director of the Office of Policy in the Office of the National Coordinator for Health Information Technology (ONC), U.S. Department of Health and Human Services (HHS). She served for a decade as the director at the ONC and 15 years at HHS, where she helped spearhead important changes in health information privacy and health information technology to improve health care for consumers nationwide.

For more than a decade, Jodi has been responsible for thought leadership, policy development, and identifying policy drivers for health IT activities within the federal government, and ultimately established the HHS' national health IT policy. As former director at the ONC, she addressed privacy and security issues to ensure that there was clear guidance on how the initial Health Insurance Portability and Accountability Act of 1996 (HIPAA) rules applied to health IT. Jodi set the strategic direction and set policy on consumer e-health and health IT safety. She is also credited with establishing the ONC’s regulatory capacity and led the development of all ONC regulations on health IT standards and certification.

As the first senior counsel for health information technology in the Office of the General Counsel (OGC) of HHS, Jodi developed HHS's foundational legal strategies and coordinated all legal advice regarding health IT for HHS. She founded and chaired the health information technology practice group within OGC and worked closely with the Centers for Medicare and Medicaid Services in the development of the e-prescribing standards regulations and the Stark and anti-kickback rules regarding e-prescribing and electronic health records.

Latest Articles

The HHS Office of Civil Rights (“OCR”) closed out the month of April with some updates to HIPAA civil monetary penalty (“CMP”) limits and clarifications to OCR’s stance on the Privacy Rule’s application to transfers of electronic protected health information (“ePHI”) to third-party applications and application programming interfaces (“APIs”). Differential CMP Caps Based on Enforcement Discretion Under the current HIPAA Enforcement Rule, HHS employs a four-tier level of culpability scale in line with the HITECH…
On March 27, 2019, the Centers for Medicare & Medicaid Services (CMS) announced a $1.65 million competition to accelerate development of AI solutions in health care. The Artificial Intelligence (AI) Health Outcomes challenge seeks innovative, AI-driven solutions that can predict unplanned hospital and skilled nursing facility (SNF) admissions and adverse events. The challenge is a 1-year, three stage competition; the Launch State is open to the public and seeks to attract a wide range of…
In order to move health care organizations towards consistency in mitigating important cybersecurity threats to the health care sector, the Department of Health & Human Services (HHS) published multiple guidance documents on best practices for health care organizations to reduce cybersecurity risks (“HHS Cyber Guidance”). The HHS Cyber Guidance is the result of HHS’ public-private partnership with more than 150 cybersecurity and health care experts. While compliance is voluntary, this guidance serves as direction to…
  More of our health information is becoming digital every day, as new technology companies enter the health care and wellness markets. Many companies that hold a wealth of consumer health information are not covered by HIPAA. Many consumers may not realize that their health information only is protected and they only have certain rights with respect to that information when it is held by certain entities, but not when it is held by others.…
CMS has finalized the adoption of multiple CPT codes in the CY 2019 PFS that create more opportunities for providers and digital health companies to collaborate on chronic care management business models in the fee-for-service market. Virtual Check-Ins CMS finalized the creation of a new code to reimburse providers for brief “check-in” services conducted using communications technology by creating HCPCS code G2012, defined as “[b]rief communication technology-based service, e.g. virtual check-in.”…
Yesterday, the FDA released draft guidance on the management of cybersecurity in medical devices submitted to the agency for premarket review. Noting that cybersecurity threats to the healthcare sector have increased in number and severity, the FDA offered new recommendations for device design, labeling, and documentation that medical device manufacturers will need to consider during premarket submission processes. The guidance comes shortly after the FDA’s launch of its Medical Device Cybersecurity Playbook, which provides…
On October 15, 2018, the Centers for Medicare & Medicare Services (“CMS”) in the Department for Health and Human Services proposed a rule to require prescription drug manufacturers to post the Wholesale Acquisition Cost (“WAC”) for drugs and biological products covered by Medicare or Medicaid in direct-to-consumer television advertisements. The WAC reflects the manufacturer’s list price for a drug to direct purchasers, not inclusive of any discounts or rebates. CMS is proposing this rule in…
CMS has issued its 2019 Physician Fee Schedule Proposed Rule, containing highly anticipated new reimbursement policies for telehealth, remote monitoring, and other uses of digital tools, as well as updates to health IT requirements in the Quality Payment Program, with a stronger focus on patient access to health information. Comments are due September 10 at 5pm.…
This blog post has been prepared in collaboration with Validic. Mr. Schiller is CEO of Validic. Jodi Daniel is a partner in Crowell & Moring’s Health Care Group in Washington, D.C. Our healthcare system is in the midst of a fundamental shift toward value-based care to drive down costs and improve the quality of care. We won’t be able to achieve that goal without technology that allows providers to collect and use health data…
On April 17, 2018, the Food and Drug Administration (FDA) released its Medical Device Safety Action Plan which outlines FDA’s intended steps to address medical device safety while preserving enough space for innovation in the market. The FDA’s plan is the latest effort by the FDA on medical device safety, including a recent budget request seeking $70 million to create a Center of Excellence on Digital Health that would, among other things, craft new regulations…