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HITECH's HHS and FTC security breach notification requirements

McDermott Will & Emery
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USA
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August 27 2009

The Health Information Technology for Economic and Clinical Health Act (HITECH Act), part of the American Recovery and Reinvestment Act of 2009, includes significant investment in health information technology (IT) to facilitate the adoption of a nationwide health information network

OCR’s proposed revisions to accounting for disclosures standard produces strong opposition from many covered entities

McDermott Will & Emery
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USA
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October 14 2011

The Office for Civil Rights (OCR) of the U.S. Department of Health and Human Services (HHS) is reviewing comments submitted by interested parties to OCR’s proposed rule (Proposed Rule) to implement a provision of the Health Information Technology for Economic and Clinical Health Act (HITECH Act) that expands the accounting for disclosures standard under the privacy standards (Privacy Standards) adopted under the Health Insurance Portability and Accountability Act of 1996 (HIPAA

New flexibility for pharmaceutical and medical device companies in Massachusetts, but at a price

McDermott Will & Emery
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USA
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August 1 2012

In July 2012 Massachusetts amended its Gift Ban Law and its Anti-Kickback Statute, both of which are among the most restrictive state laws of their kind

FDA proposes new regulation to require sponsors to report suspected data falsification

McDermott Will & Emery
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USA
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March 9 2010

The Proposed Rule requires sponsors of clinical studies to report information indicating that any person has, or may have, engaged in falsification of data collected as part of a clinical study to the appropriate FDA center no later than 45 calendar days after the sponsor become aware of the information

GINA & HIPAA: interim final rules and privacy proposed rule published

McDermott Will & Emery
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USA
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October 15 2009

The next chapter in the ongoing effort by the federal government to narrow the permissible uses of personal health information by entities engaged in the health care industry has arrived

AAMC task force releases new guidance on managing conflicts of interest in clinical care

McDermott Will & Emery
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USA
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August 2 2010

On June 30, 2010, the Association of American Medical Colleges (AAMC) issued a report entitled In the Interest of Patients: Recommendations for Physician Financial Relationships and Clinical Decision Making (the 2010 AAMC Report, or the Report

OHRP revises federalwide assurance

McDermott Will & Emery
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USA
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July 7 2011

The Office for Human Research Protections recently revised its Federalwide Assurance application form

New FDA draft guidance regarding financial disclosures by clinical investigators

McDermott Will & Emery
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USA
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July 11 2011

New recommendations recently released by the FDA demonstrate the changing environment for conflicts of interest management and emphasize the need for pharmaceutical companies, medical device manufacturers and health care providers to ensure they have internal processes that adequately anticipate and meet the baseline requirements

HHS proposes overhaul of human subject protections for domestic clinical trials

McDermott Will & Emery
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USA
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July 28 2011

In an advance notice of proposed rulemaking published in the July 26, 2011, Federal Register, the U.S. Department of Health and Human Services issued a request for comments on amendments to 45 C.F.R. Part 46, Subpart A (the Common Rule) to improve protections of human subjects in research and to revise the research process to reduce burdens, delays and ambiguities for investigators

HHS finalizes new financial conflicts of interest regulations

McDermott Will & Emery
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USA
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September 1 2011

The U.S. Department of Health and Human Services recently published its final rule governing financial conflicts of interest involving investigators conducting Public Health Service (PHS)-supported research

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