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New Products on the Common Rule

The Common Rule is a set of a federal regulations shared by fifteen Federal departments and agencies that govern all research involving human subjects conducted or supported by the relevant department or agency. With few exceptions, research institutions subject to the Common Rule must secure informed consent from each human subject, receive approval from an Institutional Review Board (IRB), and... Read More >

New Products on the Use of Information for Research Purposes

Researchers frequently create, collect, use, and/or share individually identifiable health information to conduct research.  The HIPAA Privacy Rule dictates how research is defined, who is subject to its requirements, and what the requirements are to use individually identifiable information for research purposes. The HITECH Act's modifications to the HIPAA Privacy and Security Rule also... Read More >

New Products on Health Information Exchanges (HIEs)

For over a decade, stakeholders and policy-makers have been working to digitize the nation’s health care system to, among other goals, enable the electronic exchange of health information between providers.  Recently these efforts have driven the creation of legal entities known as “Health Information Exchanges” (HIEs).  HIEs are regionally-based groups of providers... Read More >

New Products on the Qualified Entity Program

 A “Qualified Entity or QE” is an organization approved by the Centers for Medicare & Medicaid Services (CMS) to produce performance reports on the quality and efficiency of health care providers and suppliers. The QE program was authorized by the Patient Protection and Affordable Care Act (ACA) to encourage provider performance measurement and public reporting using Medicare... Read More >

New Products on Data Collection and Use in the New Health Insurance Marketplaces

With the open enrollment period for the Affordable Care Act’s Health Insurance marketplaces drawing to a close at the end of March 2014, potential applicants and others have expressed concern about the types and amount of information that marketplaces are collecting in order to enroll individuals and families in new Qualified Health Plans.  The vast majority of marketplace enrollments... Read More >

New Products on CLIA and its 2014 Amendments

The CLIA Amendments of 1988 set forth the uniform federal regulatory quality standards for clinical laboratory testing of humans, except for clinical trials and research. CLIA empowers HHS to set the rules for laboratory testing and to certify labs, which authorizes them to conduct tests on specimens derived from humans for the purpose of diagnosis, health assessments, or prevention or... Read More >

New Products on FERPA

The Family Educational Rights and Privacy Act (FERPA) generally requires education agencies and institutions to protect the privacy of student education records. Except in specified circumstances, education agencies and institutions must obtain the consent of a student or their parent/guardian before releasing education records. To learn more about the complete scope of FERPA, including when... Read More >

New Products on ERISA Preemption of State Reporting Laws

On February 4, 2014, the U.S. Court of Appeals for the Second Circuit invalidated a Vermont law requiring health insurers to regularly submit health care data to a centralized database. The Second Circuit held that the state's law (as it applied to employee benefit plans) was preempted by the Employee Retirement Income Security Act of 1974 (ERISA), which governs employee benefit plans. ERISA... Read More >

New Products on Data Use Agreements

The HIPAA Privacy Rule establishes minimum federal requirements for the use and disclosure of protected health information (PHI) by covered entities. However, if a covered entity seeks to release PHI to a non-covered entity for research, public health activities or health care operations, then the covered entity may do so only in a “limited data set” and with an accompanying Data... Read More >

New products available on the proposed HIPAA amendments impacting the federal firearm background check database

The National Instant Criminal Background Check System (NICS) is a federal database containing the names of individuals prohibited under federal law from purchasing a firearm. Recently, the Department of Health and Human Services (HHS) announced a proposed rule amending the HIPAA regulations (governing the privacy and security of individually identifiable health information) to expressly permit... Read More >