Health Information Exchanges

On 1 July 2024, Germany has enacted stricter requirements for the processing of health data when using cloud-computing services. The new Section 393 SGB V aims to establish a uniform standard for the use of cloud-computing services in the statutory healthcare system which covers around 90% of the German population. In this blog

Continue Reading Germany enacts stricter requirements for the processing of Health Data using Cloud-Computing – with potential side effects for Medical Research with Pharmaceuticals and Medical Devices

On May 3, 2021, the European Commission (the “Commission”) opened a further public consultation (“Consultation”) on the European Health Data Space (“EHDS”).

This follows a consultation earlier in the year, on the Commission’s “Inception Impact Assessment” in relation to the EHDS.  (For further information on the earlier consultation and an overview of the EHDS, please see our blog post available here).Continue Reading European Commission Conducts Further Consultation on the European Health Data Space Initiative

On December 23, 2020, the European Commission (the “Commission”) published its inception impact assessment (“Inception Impact Assessment”) of policy options for establishing a European Health Data Space (“EHDS”).  The Inception Impact Assessment is open for consultation until February 3, 2021, encouraging “citizens and stakeholders” to “provide views on the Commission’s understanding of the current situation, problem and possible solutions”.
Continue Reading European Commission Conducts Open Consultation on the European Health Data Space Initiative

On January 6, 2021 the UK’s Department of Health and Social Care (“DHSC”)  published “A Guide to Good Practice for Digital and Data-Driven Health Technologies” (the “Guidance”).  The Guidance updates the DHSC’s “Code of Conduct for Data-Driven Health and Care Technologies” (the “Code”) (for further information on the Code see our earlier blog, here).

As with the Code, the Guidance is a valuable resource to help parties understand what the National Health Service (“NHS”) looks for when acquiring digital and data-driven technologies for use in health and care.Continue Reading UK’s Department of Health and Social Care Publishes Updated Guidance on Good Practice for Digital and Data-Driven Health Technologies

On March 9, 2020, the Department of Health and Human Services (HHS) issued two final rules aimed at improving patient access to electronic health information (EHI), as well as the standardization of modes of exchange for EHI.  The rules, which were issued by the Office of the National Coordinator for
Continue Reading HHS Finalizes Interoperability Rules

Reflecting evidence from 280 witnesses from the government, academia and industry, and nine months of investigation, the UK House of Lords Select Committee on Artificial Intelligence published its report “AI in the UK: ready, willing and able?” on April 16, 2018 (the Report). The Report considers the future of AI in the UK, from perceived opportunities to risks and challenges. In addition to scoping the legal and regulatory landscape, the Report considers the role of AI in a social and economic context, and proposes a set of ethical guidelines. This blog post sets out those ethical guidelines and summarises some of the key features of the Report.
Continue Reading Covington Artificial Intelligence Update: House of Lords Select Committee publishes report on the future of AI in the UK

In March, CMS issued a State Medicaid Directors Letter (SMDL) about the availability of enhanced federal funding for state Medicaid programs’ eligibility and enrollment (E&E) systems. This SMDL represents CMS’s most recent effort to encourage States to use commercial “off-the-shelf” technology and “software as a service,” instead of customized electronic systems developed and built specifically for individual States.
Continue Reading CMS Issues Guidance Encouraging the Use of Commercial Off-the-Shelf Technology and Software-as-a-Service for Medicaid Eligibility and Enrollment Systems

On February 29, 2016, the Centers for Medicare and Medicaid Services (CMS) issued a State Medicaid Directors Letter (SMDL) that expands the scope of expenditures eligible for the 90 percent federal match for activities to promote the use of a health information exchange (HIE) and the adoption of certified electronic health record (EHR) technology by Medicaid providers.

Specifically, this updated guidance permits States to claim the enhanced match for expenditures that promote coordination of care between entities eligible for EHR incentive payments and other Medicaid providers who may not necessarily qualify for such payments.   This SMDL supersedes earlier guidance that did not permit the enhanced match for these activities.Continue Reading CMS Expands Scope of Enhanced Match for Promotion of Health IT

Last month, the Department of Health and Human Services (HHS) announced that a number of large health care companies and providers had “agreed to implement three core commitments” to improve access to electronic health records (EHR).  HHS touted the commitments as a significant step toward increased EHR interoperability.
Continue Reading Health Care Companies Agree to “Core Commitments” to Improve Access to EHR

Open enrollment for 2016 marketplace exchange plans begins Sunday, November 1. Individuals and families will be able to enroll, re-enroll, or change their health plans from November 1, 2015 through January 31, 2016.

Several new features have been added to HealthCare.gov to ease enrollment for consumers. For the first time, consumers may preview 2016 exchange health plans and premium prices before open enrollment begins. Federal officials from the Department of Health and Human Services (HHS) are encouraging consumers to use this feature to evaluate premium prices in particular, because in many places they may be higher than last year. An online, out-of-pocket expense calculator has also been added to the website to help consumers estimate deductibles and co-payments as well as the monthly premiums.
Continue Reading HealthCare.gov to Launch Open Enrollment for 2016 Plan Year on November 1, 2016