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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 first published an Advanced Notice of Proposed Rulemaking in July 2011. According to the press release accompanying the final rule, HHS made “significant changes” to its most recent proposals (published in September 2015) in response to the 2,100+ public comments they received. The majority of the Common Rule’s changes and new provisions will go into effect in 2018. We are reviewing the final rule in detail, and a summary of changes and new provisions is forthcoming.

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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 agencies. OMB review is the last step before final publication and suggests that HHS is trying to release a final rule before President Obama leaves office on January 20, 2017. Through its Office for Human Research Protections (OHRP), HHS initially published an Advanced Notice of Proposed Rulemaking in July 2011. The Advanced Notice generated significant controversy and OHRP did not publish a notice of proposed rulemaking (Proposed Rule) for over four years, ultimately doing so on September 8, 2015. The Proposed Rule, like its earlier Advanced Notice counterpart, suggested major changes to the Common Rule, including changes...

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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 of practice, law and regulation, and policies and procedures. TJC identified the rationale for the reinstated prohibition against secure text messaging for patient care orders as one of patient safety—after “weighing the pros and cons” TJC and the Centers For Medicare and Medicaid Services (CMS) concluded that as the impact of the modality on patient safety remained unclear, and determined that approving its use was premature. Read more here about how this clarification impacts health care organizations.

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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 heels of two previous settlements reached in late May 2015 with companies that had lapsed certifications despite representations to the contrary made to online consumers. This recent activity by the FTC serves as yet another reminder to businesses to monitor their Safe Harbor program certification renewal dates and to exercise care when making representations in privacy policies related to Safe Harbor program certification. The Safe Harbor programs provide a method for U.S. companies to transfer personal data outside of the European Union (EU) or European Economic Area (EEA) consistent with the requirements of the...

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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 major credit card companies that occurred in January 2014 (the Credit Card Company Data Breach). Although the amended version of the PIPA (the Amended Act) will take effect upon its promulgation (yet to be determined), most of the provisions that will significantly affect the obligations and responsibilities of data handlers are scheduled to take effect either a year after the Amended Act’s promulgation or on January 1, 2016. For timely compliance with the amended law, companies processing customer or employee data need to keep an eye on the respective effective dates of provisions of the Amended Act that are...

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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 deceptive and abusive marketing--Argentina is injecting into their regulatory regime penalty-driven regulations that will address the problems presented by robocalls. This will preserve their beneficial use while still complying with Argentina's privacy law requirements. Specifically, the February 2015 sanctions regulation addresses the recently adopted national Do Not Call registry that was implemented at the start of this year. To comply with the Do Not Call regulations, companies need to register and download the database of individuals who do not want to be called. If companies fail to do so, they can...

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