Jodi G. Daniel

Jodi Daniel is a partner in Crowell & Moring's Health Care Group and a director at C&M International (CMI), an international policy and regulatory affairs consulting firm affiliated with Crowell & Moring. She leads the firm's Digital Health Practice and provides strategic, legal, and policy advice to all types of health care and technology clients navigating the dynamic regulatory environment related to technology in the health care sector to help them achieve their business goals.

Firm/Organization: Crowell & Moring LLP

Blogs: C&M Health Law, Data Law Insights

Latest Articles

C&M Health Law

Podcast: Digital Health Innovation

By Jodi G. Daniel, Robert Holleyman, Joe Records & Payal Nanavati

January 14, 2020

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. 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. Subscribe to Payers, Providers,…

C&M Health Law

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

By Jodi G. Daniel, Joe Records, Payal Nanavati & Shaina Vinayek

October 23, 2019

Payers, Providers, and Patients – Oh My! Is Crowell & Moring’s biweekly health care podcast, discussing legal and regulatory issues that affect health care entities’ in-house counsel, executives, and investors. In this episode, hosts Payal Nanavati and Joe Records discuss recent FDA guidance related to digital health with Jodi Daniel and Shaina Vinayek. For more information on this topic, please see our previous blog post. Subscribe to Payers, Providers, and Patients – Oh…

C&M Health Law

FDA Seeks Comment on Clinical Decision Support Software Guidance and Issues Policy Updates on its Oversight Authority Regarding Medical Software and Apps

By Jodi G. Daniel, Stephanie Willis & Shaina Vinayek

October 23, 2019

In September 2019, the Food & Drug Administration (FDA) issued a new draft “Clinical Decision Support Software” guidance for public comments, which are due December 26, 2019. Concurrently, the agency published updates to four related guidance documents centered on regulation of digital health software products along with a consolidated summary titled “Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act,”[1] but is not…

C&M Health Law

Trump Administration’s Executive Order Calls for Innovation in Services, Technology, and Payment Models for Medicare and Medicare Advantage

By A. Xavier Baker, Jodi G. Daniel & Grace Fleming

October 8, 2019

medicare-and-medicaid-national-health-insurance-program-in-the-united-picture-id1156622320

On October 3, President Trump signed an Executive Order on Protecting and Improving Medicare for Our Nation’s Seniors (EO), directing the Department of Health and Human Services (HHS) to develop various proposals to “protect and improve the Medicare” program as an alternative to the Medicare for All Act. The EO aims to: • Expand Medicare Advantage (MA), • Encourage innovative plan designs, and • Reduce regulatory burdens on providers These policies, if implemented, could have…

C&M Health Law

OCR Announces First Enforcement Action Under Its Right to Access Initiative

By Brandon C. Ge & Jodi G. Daniel

September 11, 2019

On Monday, the Office for Civil Rights (“OCR”) at the U.S. Department of Health & Human Services (“HHS”) announced an enforcement action against Bayfront Health St. Petersburg (“Bayfront”) for allegedly failing to provide a mother timely access to her unborn child’s prenatal medical records. The enforcement action is noteworthy in that it marks OCR’s first enforcement action under its Right of Access Initiative, announced earlier this year to focus more on enforcing patients’ rights to…

C&M Health Law

New Proposed Rules on Confidentiality of Substance Use Disorder Data Would Address Care Coordination and Law Enforcement Challenges

By Jodi G. Daniel, Stephanie Willis, Brandon C. Ge & Maya Uppaluru

August 28, 2019

HHS’s Substance Abuse and Mental Health Services Administration (“SAMHSA”) proposed updated rules to clarify the scope of perceived barriers to sharing information regarding treatment for substance use disorders (SUDs) among providers, with research entities, and for law enforcement purposes. The proposed changes to the 42 C.F.R. Part 2 (“Part 2”) regulations appear in two Notices of Proposed Rulemaking (“NPRMs”), which are also summarized in a Fact Sheet. These proposals are part of HHS’s…

C&M Health Law

Allscripts Close to Reaching Deal with DOJ for Health IT Certification, Anti-Kickback Statute, and HIPAA Issues

By Jodi G. Daniel, Stephanie Willis & Maya Uppaluru

August 16, 2019

Electronic health record (EHR) vendor Allscripts recently disclosed on an earnings call that it has reached a tentative agreement with the Department of Justice (DOJ) to pay $145 million to settle an investigation into the regulatory compliance of one of its recent acquisitions, Practice Fusion. This news, combined with DOJ’s other recent successful enforcement actions against EHR companies, represents a trend and should be a warning that compliance is a priority when it comes health…

C&M Health Law

Trump Administration and Congress Are Moving Quickly on Health Care Price Transparency and Lowering Costs

By Maya Uppaluru, Jodi G. Daniel, Mike Lieberman & Joseph Miller

August 1, 2019

A patient has an emergency and goes to a hospital she knows is in her plan’s network. She receives treatment. She leaves the hospital. Weeks later, she receives a medical bill for tens of thousands of dollars. Unbeknownst to her, some or all of her treating doctors were out-of-network. This all-too-common story has contributed to a significant medical debt crisis in this country, and has captured the attention of policymakers on all sides of the…

C&M Health Law

HIPAA Spring Cleaning! Tidying Up Penalty Limits and FAQs on Patients’ Right of Access

By Jodi G. Daniel & Stephanie Willis

May 15, 2019

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…

C&M Health Law

CMS offers $1.65 million in AI Health Outcomes Challenge

By Jodi G. Daniel & Amber Mulcare

April 23, 2019

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…

Jodi G. Daniel

Podcast: Digital Health Innovation

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

FDA Seeks Comment on Clinical Decision Support Software Guidance and Issues Policy Updates on its Oversight Authority Regarding Medical Software and Apps

Trump Administration’s Executive Order Calls for Innovation in Services, Technology, and Payment Models for Medicare and Medicare Advantage

OCR Announces First Enforcement Action Under Its Right to Access Initiative

New Proposed Rules on Confidentiality of Substance Use Disorder Data Would Address Care Coordination and Law Enforcement Challenges

Allscripts Close to Reaching Deal with DOJ for Health IT Certification, Anti-Kickback Statute, and HIPAA Issues

Trump Administration and Congress Are Moving Quickly on Health Care Price Transparency and Lowering Costs

HIPAA Spring Cleaning! Tidying Up Penalty Limits and FAQs on Patients’ Right of Access

CMS offers $1.65 million in AI Health Outcomes Challenge

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