Last Tuesday afternoon, the US Food and Drug Administration (FDA) held a webinar to outline a recently-published Digital Health Innovation Action Plan (Plan). In the Plan, the agency recognized that the traditional regulatory approach toward moderate and high risk medical
Of Digital Interest
Legal news and analysis of all things digital
Of Digital Interest, published by McDermott Will & Emery, focuses on legal developments and issues related to data privacy, cybersecurity, and digital regulation. The blog covers topics such as compliance with the California Consumer Privacy Act (CCPA) and its enforcement, litigation trends involving privacy rights, and proposed legislative changes like the California Privacy Rights Act. It also addresses emerging concerns around technologies such as facial recognition systems, including their legal, ethical, and accuracy challenges. The blog provides insights into how evolving digital laws impact businesses, particularly in areas like data security, consumer rights, and regulatory enforcement.
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Regulating the Internet of Toys
New technologies and the expansion of the Internet of Things have allowed children of this generation to experience seamless interactive technologies through microphones, GPS devices, speech recognition, sensors, cameras and other technological capabilities. These advancements create new markets for entertainment…
False Claims Act Settlement with eClinicalWorks Raises Questions for Electronic Health Record Software Vendors
On May 31, 2017, the US Department of Justice announced a Settlement Agreement under which eClinicalWorks, a vendor of electronic health record software, agreed to pay $155 million and enter into a five-year Corporate Integrity Agreement to resolve allegations that…
Round Two: Significant Telehealth Expansion Re-Proposed in Bipartisan Senate Bill
On May 3, 2017, the Creating Opportunities Now for Necessary and Effective Care Technologies for Health Act of 2017 (S. 1016) (CONNECT Act of 2017) was reintroduced by the same six senators who had initially introduced the legislation in early…
OIG Reports More Than $731 Million in Inappropriate Medicare Meaningful Use Payments
The Electronic Health Records (EHR) Incentive Program run by Centers for Medicare and Medicaid Services (CMS) garnered attention again last week following the release of a report by the Office of Inspector General of the US Department of Health and…
Texas Changes its Tone on Telemedicine
As one of the last states to retain highly restrictive (and arguably anti-competitive) telemedicine practice standards, health care providers, regulatory boards, technology companies, payors and other stakeholders have been actively monitoring Texas’ approach to telemedicine regulation and the related Teladoc…
China’s Network Security Law Comes into Effect: What It Means for Your Company
Today, China’s much anticipated Network Security Law comes into effect after two years of review, revisions over three drafts and a public commenting process. The law is a historical development for China’s legislative coverage of information security and data protections.…
Recent $2.5 Million OCR Settlement Is a Warning to Wireless Health Service Providers
On April 24, the US Department of Health and Human Services (HHS) Office for Civil Rights (OCR) announced a Health Insurance Portability and Accountability Act of 1996 (HIPAA) settlement in the amount of $2.5 million based on the impermissible disclosure…
Guide from the Italian Data Protection Authority on the Application of the GDPR: Recommendations on How to Get Started!
On April 28, 2017, the Italian Data Privacy Authority published a Guide on the application of the new General Data Protection Regulation (GDPR). The Guide does not set out implementing rules of the GDPR but rather provides a summary of…
More Federal Legislation Aimed at Expanding Medicare Coverage of Telehealth Services
Late last month, Senator Cory Gardner (R-CO) and Senator Gary Peters (D-MI) introduced Senate Bill 787, the Telehealth Innovation and Improvement Act (Telehealth Improvement Act), which is focused on expanding Medicare’s currently limited coverage of telehealth services and opportunities…