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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

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

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

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

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

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

Navigating the evolving regulation and commercialization of stem cell research

McDermott Will & Emery
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European Union, USA
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March 22 2012

Interested parties that can successfully navigate the evolving regulation of stem cell research stand to gain significant scientific and commercial advantage

FCC announces rulemaking enabling remote monitoring of health care data

McDermott Will & Emery
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USA
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June 20 2012

The Federal Communications Commission recently adopted rules that will enable the growth of Medical Body Area Networks, low-power wideband networks that transmit a variety of patient data recorded through patient-worn sensors to a hub device

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