C&M Health Law

C&M Health Law

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

Tag Archives: Digital Health

Early Stage Investing in Health Technology

Posted in Digital Health, Digital Transformation, Medicaid, Medicare
Next week, on June 21, 2018, attorneys from Crowell & Moring will hold a bootcamp entitled “Early Stage Investing in Health Technology.” Crowell & Moring attorneys will present on topics of interest to entrepreneurs, investors, and early stage health technology companies. Attendees will have the opportunity to learn about a range of matters including formation… Continue Reading

Transforming the Patient-Provider Relationship: A Comprehensive Approach to Patient Access and Patient-Generated Health Data

Posted in Health IT
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… Continue Reading

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

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

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

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

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

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

You’re Invited: Fostering Innovative Digital Health Strategies Conference June 23rd

Posted in Health IT
Accenture and Crowell & Moring LLP are excited to host the “Fostering Innovative Digital Health Strategies” conference on June 23, 2016 at the Crowell & Moring Washington, DC office. This event will bridge the intersection of business, legal, and policy issues that innovative companies face in developing and integrating successful digital health tools and platforms.… 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