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 in the Health Care Economy’s Internet of Things,” featured the following distinguished panelists: Zane Burke (president, Cerner); Jodi Daniel (partner, Crowell & Moring); Cheryl Falvey (partner, Crowell & Moring); Melissa Goldstein (assistant director, Bioethics and Privacy Office of Science and Technology Policy, Executive Office of the President); and Kaveh Safavi (senior managing director, Global Health Industry Lead, Accenture).

A series of five videos from the session can be watched below:

Here are key health care Internet of Things (IoT) trends discussed in Session 1:


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

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 using digital health technologies. The conference covered a wide array of digital health topics, including trends in the healthcare Internet of Things, setting up digital health platforms, legislative activity regarding health IT and telehealth, privacy, cybersecurity, and use of digital health technology to support new payment models.

Session 2, “Setting up a Platform for Digital Health,” featured panelists Jodi Daniel (Partner, Crowell & Moring), Bakul Patel (Associate Director for Digital Health, Center for Devices and Radiological Health, FDA), Anna Shimanek (Senior Legal Counsel, CVS Health), Paul L. Uhrig (EVP, Chief Administrative, Legal, & Privacy Officer, Surescripts) and Ronan Wisdom (Managing Director, Accenture Digital).  Key takeaways include:

  • New partnerships are emerging. There is a broad movement among a variety of stakeholders – providers, payors, consumers, technology companies, and the government – toward using digital health to improve communicating with providers and patients’ understanding of their own health. This leads to new opportunities to partner with other organizations and require strategies for doing so effectively from a legal and business perspective.


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

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 the feasibility of establishing mechanisms to assist providers in comparing and selecting certified EHR technology products. Congress suggested that ONC consider mechanisms like establishing a website of aggregated survey results that would allow meaningful EHR users to directly compare the functionality of certified health IT products. Congress also suggested compiling information from vendors of certified health IT products, and making that information publicly available in a standardized format.

In response to its Congressional directive, and drawing upon recommendations from the Certified Technology Comparison (CTC) Task Force, public input, and its own market analysis, ONC’s report focused on two subgroups of the health care community – providers and comparison tool developers – and identified specific problem areas in the comparison tool marketplace. Ultimately, the report proposed four mechanisms to improve the health IT comparison marketplace:


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

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

On February 25, President Obama addressed a small audience at the White House, identifying the need for patient participation in health care and the importance of individualizing treatments for a particular patient. Obama said that precision medicine can lead to reduced costs, better care, and a more efficient health care system.  He stated “the health care system is actually more of a disease-care system in which the patient is passive, you wait until you get sick, a bunch of experts then help you solve it,” and that precision medicine is about “empowering individuals to monitor and take a more active role in their own health.” His remarks were quite genuine and showed his personal interest in precision medicine as he seemed to talk “off script” with his panelists.

A year ago the President launched the Precision Medicine Initiative (PMI) to accelerate medicine that delivers the right treatment at the right time to the right person, taking into account individuals’ health history, genes, environments, and lifestyles. This includes efforts by the NIH to build a 1 million-person voluntary national research cohort who will partner with researchers, share data, and engage in research to transform our understanding of health and disease through precision medicine.  It also includes efforts by the Department of Veterans Affairs (VA), which has enrolled over 450,000 Veterans in the Million Veteran Program (MVP), a participant-driven research cohort.Vice President Biden’s cancer moonshot initiative builds on this initiative.


Continue Reading President Obama Addresses Precision Medicine, Health IT, Data Access, and Security

The Office of the National Coordinator for Health Information Technology (“ONC”) began the month of March and the HIMSS Annual Conference with the announcement of an unexpected proposed rule, the Enhanced Oversight and Accountability Rule (the “Oversight Rule”). The Oversight Rule would expand ONC’s role in the ONC Health IT Certification Program (“Program”). Specifically, the Oversight Rule provides ONC with express powers to directly review health IT certified under the Program and employ review, suspension, and termination processes to address “non-conformities” found in certified health IT.  The ONC is seeking comment on key issues such as the scope of ONC’s proposed direct review authority, its processes for reviewing certified and uncertified health IT capabilities, and the agency’s potential overlap with the authority of other agencies.  All public comments will be due to ONC on or before May 1, 2016.

As stated in the ONC’s press release, the Oversight Rule focuses on three areas: Direct Review, Enhanced Oversight, and Greater Transparency and Accountability.


Continue Reading The ONC Proposes the Direct Review of Certified Health IT in Oversight Rule

A key event in Congress affecting health information technology occurred last week when two members of the Senate HELP Committee issued a discussion draft of their bipartisan legislation on health information technology (health IT).  This ambitious bill addresses many of the same areas as other recent bills, including information blocking, transparency, a star rating system