C&M Health Law

C&M Health Law

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

Tag Archives: Interoperability

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

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

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

Health Information Blocking Leads to New Requirements and May Lead to Enforcement Actions

Posted in Fraud, Waste & Abuse, Health IT
The federal government has spent billions to promote adoption and “meaningful use” of health information technology (HIT). There is growing government interest in ensuring that HIT is used to support patient care, but doing so requires electronic exchange of information. Congress, the Department of Health and Human Services (HHS), and States have taken action to… Continue Reading

CMS and ONC Announce New Proposed Rules for Stage 3 of the Medicare and Medicaid EHR Incentive Program and HIT Certification Criteria

Posted in Health Care Reform & ACA, Health IT
On March 30, the Centers for Medicare & Medicaid Services (CMS) published a proposed rule (CMS Proposed Rule) detailing the policies it will introduce during Stage 3 of the Medicare and Medicaid Electronic Health Record (EHR) Incentive Program. In tandem with CMS’s publication, the Office of the National Coordinator for Health Information Technology (ONC) also… Continue Reading