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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 it caused its customers to submit false claims for Medicare and Medicaid meaningful use payments … Continue Reading

What You Need to Know about Changes to the Common Rule

The Final Rule published by the US Department of Health and Human Services on January 18, 2017, largely avoids major modifications to the Common Rule. However, it specifically addresses creation of biospecimen and data repositories and use of those repositories for secondary research. All stakeholders involved in federally funded research should be aware of the … Continue Reading

HHS Finalizes Overhaul of Federal Human Subjects Research Protections

On January 18, 2017, the Department of Health and Human Services (HHS) and 15 other federal agencies issued a final rule overhauling the federal human subjects research regulations known as the “Common Rule.” These are the first revisions to the Common Rule since its original enactment in 1991, and have been in progress since HHS … Continue Reading

OMB Reviewing Common Rule Overhaul

On January 4, 2017, the Department of Health and Human Services (HHS) submitted a draft final rule to amend the federal human research regulations to the Office of Management and Budget (OMB). These regulations, often referred to as the Common Rule, were originally developed in 1991 and have been adopted by multiple federal departments and … Continue Reading

The Joint Commission Puts the Brakes on Text Messaging Patient Orders

The Joint Commission (TJC) recently clarified that licensed independent providers (LIPs) or other practitioners may not utilize secure text messaging platforms to transmit patient care orders. TJC’s earlier position provided that use of secure text messaging platforms was an acceptable method to transmit such orders, provided that the use was in accordance with professional standards … Continue Reading

The FTC Continues to Flex its Safe Harbor Enforcement Muscles

On August 17, 2015, the Federal Trade Commission (FTC) announced settlements with 13 companies on charges that they misled consumers by claiming that they were certified members of the U.S.-EU or U.S.-Swiss Safe Harbor programs when in fact their certifications had lapsed or never existed in the first place. The FTC’s announcement comes on the … Continue Reading

Amendment to the Personal Information Protection Act Passed in the National Assembly July 6, 2015

On July 6, 2015, the Korean National Assembly passed a bill containing several amendments to the Personal Information Protection Act (PIPA). This bill (the Amendment Bill) combines a number of major provisions from nine previous different bills – e.g., one introduced in 2013 and eight proposed in 2014 following the massive data breach of three … Continue Reading

Argentina Adopts New Data Protection Regulations for the Use of Do Not Call Registry and CCTV

The Argentinian Data Protection Authority (DPA) beefs up penalties to fight robocalls and unconsented-to video surveillance by enacting Do Not Call and CCTV regulations. Because robocalls are cheap and efficient, they have become a quite popular form of advertising in Argentina. In order to curb the variety of abuses that can come from robocalling–such as … Continue Reading
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