C&M Health Law

C&M Health Law

Analysis, commentary, and the latest developments in health care law and policy

Jodi G. Daniel

Jodi G. Daniel

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.

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FDA’s Medical Device Safety Action Plan

Posted in Digital Health, FDA, Health IT
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… Continue Reading

FDA Advances Flexibility-Based Framework for Digital Health and AI

Posted in FDA, Health IT, Medicaid, Medicare
The Food and Drug Administration (FDA) has announced several new initiatives that reflect its ongoing commitment to maintain patient safety, while also championing the need and opportunity for health care innovation. During opening day of Health Datapalooza, FDA Commissioner Scott Gottlieb highlighted the critical import of novel digital health tools in achieving patient-centered care, and… Continue Reading

The Freight Train Gathers Steam: An Update on the Federal Response to the Opioid Crisis

Posted in FDA, Medicaid, Medicare
Despite the Trump Administration’s declaration of a state of emergency on October 26, 2017, the federal response to the opioid crisis largely languished on the back burner—much to the chagrin of states in the trenches of the opioid epidemic. However, based on the flurry of activity over the past several weeks, the federal government response… Continue Reading

CMS Signals Future Patient Access Requirements for Medicare Advantage Plans

Posted in Health IT, Medicare
Building on momentum from Administrator Seema Verma’s announcement of the MyHealtheData initiative at HIMSS 2018, CMS has published more clues as to future action to liberate health information for patients. In the CY 2019 call letter to Medicare Advantage organizations and Part D programs, CMS describes the Blue Button 2.0 project and its use of… Continue Reading

Liberating Data to Transform Value-Based Care: MyHealthEData, Blue Button 2.0, and Price Transparency

Posted in Health IT
On March 6, 2018 at the Healthcare Information and Management Systems Society (HIMSS) 2018 conference, Centers for Medicare & Medicaid Services (CMS) Administrator Seema Verma announced a new initiative furthering the current Administration’s focus on value-based care and increasing patient access to healthcare data. The initiative — called MyHealthEData — will be led by the… Continue Reading

FDA Issues New Guidance for Clinical and Patient Decision Support Software

Posted in Digital Health, EHR, Health IT
This morning, the Food and Drug Administration released highly anticipated guidance on clinical and patient decision support that has been in the works at the agency for several years, advising the digital health community about how it plans to regulate software that offers recommendations or feedback to its users—both healthcare professionals, and patients and caregivers.… Continue Reading

New Reimbursement for Remote Patient Monitoring and Telemedicine

Posted in EHR, Health IT, Medicare
CMS announced important changes to Medicare reimbursement for remote patient monitoring and telemedicine that can help accelerate adoption and use of these digital health tools. These changes are implemented through two rules released this week that will take effect January 1, 2018. Understanding these rules can help you incorporate these tools into clinical practice and… Continue Reading

Interoperability by Design: FDA Issues New Final Guidance for Connected Medical Devices

Posted in FDA, Health IT
The FDA is focusing on safety and effectiveness of interconnected medical devices with the issuance of final guidance on medical device interoperability, released last week. As the FDA notes, medical devices are becoming increasingly connected to one another and to other technologies, and it is critical to address their ability to exchange and use information… Continue Reading

Hospitals Beware: Medicare Electronic Health Records Incentive Payments to Hospitals are in the OIG’s Crosshairs

Posted in Digital Health, EHR, Fraud, Waste & Abuse, Health IT
The Department of Health and Human Services, Office of the Inspector General (OIG), modified its Work Plan to announce that the agency will be conducting a nationwide audit of hospitals that participated in the Medicare Electronic Health Records (EHR) Incentive Program (also known as the Meaningful Use Program).  The OIG review is focusing on hospitals… Continue Reading

Congress Remains Focused on Electronic Health Records

Posted in Digital Health, EHR, Health IT
Congress is considering several adjustments to health IT policy which may have significant impact on the Centers for Medicare and Medicaid Services’ (“CMS”) electronic health records (“EHR”) incentives. On July 20th and 21st, Representatives met to discuss bipartisan legislation to improve the Meaningful Use program and introduced legislation that would authorize a CMS Innovation Center… Continue Reading

Bringing Innovative Technology to Healthcare…What about HIPAA?

Posted in Health IT, HIPAA & Privacy
If you are a technology company developing products for the health market, you have probably heard about and maybe even been “warned” about HIPAA (the Health Insurance Portability and Accountability Act). If you are asking, “How can I avoid complying with HIPAA?” you might be asking the wrong question. Health care is almost 20 percent… Continue Reading

The AMA Takes a Position on Mobile Health Applications

Posted in Health IT
The AMA recently adopted a set of principles on mHealth applications (mHealth apps) and other similar digital health tools, to guide coverage and payment policies and the AMA’s advocacy efforts. While many have touted the potential health benefits of mHealth apps and digital devices, the AMA also raises concerns about the potential health and safety… Continue Reading

ONC Releases New Guidance on Electronic Health Record Vendor Contracting

Posted in Health IT
On September 26, 2016, the Office of the National Coordinator for Health Information Technology (ONC) released guidance, entitled EHR Contracts Untangled, to help providers navigate the complexities of electronic health record (EHR) vendor contracting. The guidance breaks down important considerations for selecting EHR systems, and provides strategic pointers – including sample contract language – to… Continue Reading

Blocking Access to Health Information May Violate HIPAA

Posted in Health IT, HIPAA & Privacy
The HHS Office of Civil Rights published a new FAQ response (OCR FAQ) detailing the agency’s position that generally information blocking will violate the HIPAA Privacy and Security Rules if it affects a covered entity’s access to its own protected health information (PHI) or its ability to respond to requests for access to PHI from… Continue Reading

Addressing Health Privacy and Security Gaps in ONC Report

Posted in Health IT, HIPAA & Privacy
On July 19th, the Office of the National Coordinator for Health Information Technology (“ONC”) released a report expressing concerns about major gaps in policies and oversight surrounding the access to, security, and privacy of health information held by certain mobile health (“mHealth”) technology companies and health social media.  While the report frames the issue well,… Continue Reading

FDA Finalizes Guidance on Low Risk “General Wellness Products”

Posted in Health IT
In a final guidance document released July 29th, the U.S. Food and Drug Administration (“FDA”) officially confirmed that it does not intend to review or require regulatory compliance for fitness trackers and certain health apps, collectively termed “general wellness products.”  This guidance, which is largely unchanged from the draft guidance issued in January 2015, coincides… Continue Reading

Digital Health, Big Data, Cybersecurity, and Privacy – Four Key Takeaways from C&M’s Digital Health Strategies Conference

Posted in Health IT, HIPAA & Privacy
In late June, Crowell & Moring partnered with Accenture to host a comprehensive one-day conference on legal issues affecting the digital health landscape. The program covered a wide range of topics, some of which you can read more about via the following links: Developing Digital Health Platforms; the Health Care Economy’s Internet of Things; and… Continue Reading

New Payment Models and Data: Changes and Themes to Watch

Posted in Events, Fraud, Waste & Abuse, Health IT, Medicare
On June 23, Crowell & Moring and Accenture co-hosted the Fostering Innovative Digital Health Strategies Conference in Crowell’s D.C. office. The conference provided a broad analysis of the business and legal issues that must be addressed as health care organizations and technology companies consider innovative strategies to use digital health technologies. The conference covered several… Continue Reading

6 Trends in the Health Care Economy’s Internet of Things

Posted in Events, Health IT, HIPAA & Privacy
Crowell & Moring and Accenture co-hosted a conference, “Fostering Innovative Digital Health Strategies,” in late-June. The program aimed to provide a broad analysis of the business and legal issues that must be addressed as health care organizations and technology companies consider innovative strategies to use digital health technologies. The first session of the conference, “Trends… Continue Reading

In Case You Missed It . . . Five Key Takeaways in Developing Digital Health Platforms

Posted in Health IT
On June 23, Crowell & Moring and Accenture co-hosted the Fostering Innovative Digital Health Strategies Conference in Crowell’s D.C. office. The goal of the conference was to take a comprehensive look at all of the business and legal issues that need to be addressed as health care organizations and technology companies are considering innovative strategies… Continue Reading

The Rise of the One-Stop Shop? ONC Outlines Four Mechanisms to Help Providers Compare Certified Health IT Products

Posted in Health IT
Earlier this month, the Office of the National Coordinator for Health Information Technology (ONC) released a report to Congress on the feasibility of creating tools to help providers compare and select certified health IT products. As part of the Medicare Access and CHIP Reauthorization Act (MACRA), Congress required ONC to conduct a study to examine… Continue Reading

Help Shape Federal Policy on the Internet of Things

Posted in Health IT
The National Telecommunications and Information Administration (NTIA) is looking for input on federal policy related to the Internet of Things (IoT).  On April 5, NTIA published a request for comment on federal efforts to promote IoT efforts and foster innovation.  The Department of Commerce will use the comments to develop a “green paper” identifying key… Continue Reading

Tell HHS How to Measure Interoperability

Posted in Health IT
Congress set its sights on achieving the widespread exchange of health information through interoperable-certified electronic health records (“EHR”) by declaring it a national objective in the Medicare Access and CHIP Reauthorization Act of 2015 (“MACRA”). To accomplish this goal, MACRA directs the Department of Health and Human Services (“HHS”) to establish metrics in consultation with… Continue Reading

Medicaid Matching Funds Available to Connect Providers Eligible for Meaningful Use with other Providers

Posted in Health IT, Medicaid
There is a very significant funding opportunity for State Medicaid Programs, which can support use of health information technology by health care providers that provide care to Medicaid recipients and those who may exchange information with Medicaid providers eligible for Meaningful Use incentives. It may also benefit technology developers that are engaged in health information… Continue Reading