C&M Health Law

C&M Health Law

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

Category Archives: Health IT

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New OCR Settlement Targets Safety Net Provider on Security Rule Deficiencies

Posted in Health IT, HIPAA & Privacy
On Wednesday, the U.S. Department of Health and Human Services, Office for Civil Rights announced a $400,000 settlement with Metro Community Provider Network arising from MCPN’s alleged failure to implement adequate security management processes to safeguard electronic protected health information in accordance with the Health Insurance Portability and Accountability Act Security Rule. This settlement followed… 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

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

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

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

Posted in Health IT, HIPAA & Privacy
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… Continue Reading

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

Posted in Health IT
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… Continue Reading

Congress Introduces Bipartisan Bill to Expand Telehealth, Remote Patient Monitoring

Posted in Fraud, Waste & Abuse, Health IT, Medicaid, Medicare
Last week, Democrats and Republicans from both chambers introduced the Creating Opportunities Now for Necessary and Effective Care Technologies (CONNECT) for Health Act (S. 2484, H.R. 4442), which would improve health care quality and realize cost savings by eliminating current restrictions on telehealth and remote patient monitoring. Click here to read our detailed analysis of… Continue Reading

HHS Proposes New Substance Abuse Confidentiality Rules, Solicits Comments

Posted in Health IT, HIPAA & Privacy
The U.S. Department of Health and Human Services (“HHS”) announced a proposed rule to modernize the federal substance abuse confidentiality rules set forth in 42 C.F.R. Part 2.  The proposed updates seek to address longstanding complaints from providers and Health Information Exchanges (“HIE”) that the highly stringent confidentiality rules often stymie patient care by limiting… Continue Reading

Senate Health IT Bill May Get Traction

Posted in Health IT, HIPAA & Privacy
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… Continue Reading

Crowell & Moring’s 2016 Litigation & Regulatory Forecasts: What Corporate Counsel Need to Know for the Coming Year

Posted in Administrative Law, Antitrust, EHR, Health Care Reform & ACA, Health IT, Litigation, Medicaid, Medicare, Tax
Featured Industry: Health Care Spotlight on Best Practices, Litigation, Antitrust, and Tax for Health Care Companies Crowell & Moring LLP is pleased to release its “2016 Litigation & Regulatory Forecasts: What Corporate Counsel Need to Know for the Coming Year.” The reports examine the trends and developments that will impact health care companies and other… Continue Reading

U.S. Copyright Office Authorizes New Access to Medical Device Programs and Data under Digital Millennium Copyright Act

Posted in FDA, Health IT
On October 28, 2015, the U.S. Copyright Office of the Library of Congress (the “Office”) issued a Final Rule containing several exemptions to the Digital Millennium Copyright Act that expanded access to medical device computer programs and the patient data they generate.  The Digital Millennium Copyright Act allows intellectual property holders to install “technological protection… Continue Reading