What Is the Information Blocking Rule? – Faegre Drinker on Law and Technology Podcast

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Want to better understand what the Office of the National Coordinator for Health IT’s (ONC) Information Blocking Rule (IBR) is, how it works and why we need it? In this episode of the Faegre Drinker on Law and Technology Podcast, host Jason G. Weiss sits down with Faegre Drinker partners Jeff Ganiban and Doriann Cain, and associate Alex Eschenroeder to discuss all things IBR.

Expected in September 2022, the final draft of the HHS Office of Inspector General’s (OIG) first IBR enforcement rule is aimed at two of the three actor types defined in the IBR: Health IT Developers of Certified Health IT and Health Information Networks / Health Information Exchanges. Under the Cures Act, each IBR violation by a Health IT Developer of Certified Health IT or Health Information Network / Health Information Exchange would be subject to penalties of up to $1 million. The expected rule will establish how the OIG intends to assess and enforce these penalties. (Unfortunately, there is still no guidance on when we can expect a rule regarding the penalties that will apply to IBR violations by Health Care Providers.)

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How We Spent Our Summer Vacation or Summary of CCPA Amendments

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The long anticipated amendments to the CCPA were passed by the California Legislature in early September and now await Governor Newsom’s signature.  Some of the changes were “clean up” amendments to update cross references, standardize language, and generally address issues of drafting.  What follows is a summary of the most significant and substantive amendments:

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$3 Million Settlement for Two Separate HIPAA Breaches Affecting Over 62,500 Individuals

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Cottage Health and the Office for Civil Rights at the U.S. Department of Health and Human Services (HHS-OCR) recently entered into a $3 million no-fault settlement and three year corrective action plan to settle potential violations of the Health Insurance Portability and Accountability Act (HIPAA). This was HHS-OCR’s last HIPAA related settlement of 2018 – a record year in HIPAA enforcement activity, as detailed in this DBR on Data blog post.

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2018 An All-Time Record Year for HIPAA Enforcement Actions by HHS-OCR

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The Office for Civil Rights at the U.S. Department of Health and Human Services (HHS-OCR) had a record-breaking year in 2018 with Health Insurance Portability and Accountability Act (HIPAA) enforcement activity.  HHS-OCR entered into 10 settlements and received summary judgment in a case before an Administrative Law Judge, totaling nearly $28.7 million in enforcement actions. According to the HHS-OCR Director, Roger Severino, this record year underscores the need for covered entities to be proactive about their HIPAA data security.

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FDA Releases Updated Working Model for Software Precertification Program

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The U.S. Food and Drug Administration (FDA) recently released “A Working Model v.1.0” for its Software Precertification Program, which is aimed at organizations that design, test and monitor software products used for medical purposes (“Software as Medical Device” or “SaMD” products).  The goal of the Software Precertification Program is to encourage innovation in digital health technologies by streamlining regulatory approaches while ensuring patient safety and device effectiveness.

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Another Big Blockchain Initiative Announced in Health Care Insurance Industry

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Several large health insurance companies, including Aetna, Anthem, and Healthcare Service Corporation, have announced a collaboration with PNC Bank and IBM to utilize blockchain technology to “improve transparency and interoperability in the health care industry” and “address a range of industry challenges, including promoting efficient claims and payment processing, to enable secure and frictionless healthcare information exchanges, and to maintain current and accurate provider directories.”

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