Health Science, Computers & Technology

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HHS releases new software for updating (but not replacing) HIPAA security risk assessment toolkits

Last week, the Department of Health and Human Services (HHS) released a new, free, downloadable tool to assist small and medium-size health care provider offices to conduct security risk assessments (SRA)....more

Free HIPAA Help

Health care providers, health plans, business associates, and other entities affected by the federal HIPAA privacy and security regulations are quickly running out of excuses for not having a robust HIPAA compliance program...more

OCR Releases Information on What Phase 2 HIPAA Audits Will Look Like

The HHS Office for Civil Rights (OCR) recently presented information about the new look of its Phase 2 audit program. The new audits will look little like the old ones, with OCR conducting the audits itself and focusing on...more

FDA Seeks Information for Implementation of Drug Supply Chain Security Act

On November 27, 2013, the Drug Supply Chain Security Act (DSCSA) was enacted "to build an electronic, interoperable system to identify and trace certain prescription drugs as they are distributed within the United States." To...more

Special New York Edition: Summary of the 2014-2015 Work Plan of the New York State Office of the Medicaid Inspector General

On April 2, 2014, the New York State Office of the Medicaid Inspector General (OMIG or the Agency) released its Medicaid Work Plan (the Work Plan) for federal fiscal year 2014. OMIG’s core function is to prevent, detect, and...more

Overview of Primary Provisions of U.S. and French Sunshine Reporting Requirements

2013 was a year of unprecedented scrutiny of financial relationships between manufacturers and health care professionals, such as physicians. Both the United States and France imposed sweeping new reporting and disclosure...more

2015 Payment Notice and Final Call Letter: A Mixed Bag for Medicare Advantage and Prescription Drug Plans

On April 7, 2014, the Centers for Medicare & Medicaid Services ("CMS") released the Announcement of Calendar Year ("CY") 2015 Medicare Advantage ("MA") Capitation Rates and Medicare Advantage and Part D Payment Policies...more

New HIPAA Tool Released by the Federal Government – Makes Assessing Risks Easier and It Won’t Cost You a Dime

Do you lie awake at night wondering if you or the health care entity for which you work is complying with the Health Insurance Portability and Accountability Act (“HIPAA”)? If so, you will be happy to hear that a good night’s...more

Federal agencies propose health IT regulatory framework, seek stakeholder input and participation in new initiatives

A little more than five years after the passage of the Health Information Technology Economic and Clinical Health (HITECH) Act, the Food and Drug Administration, Federal Communications Commission and the Office of the...more

Indiana Governor Signs Biosimilar Substitution Bill

On March 25, Indiana Governor Mike Pence signed legislation (Senate Bill 262) that will allow pharmacists in Indiana to substitute an interchangeable biosimilar product for a prescribed biological product if certain...more

Two Recent 340B Developments: New Hospital Registration Guidance and Proposed Rules Under Review at OMB

Earlier this week, the much-anticipated 340B Drug Pricing Program (340B Program) proposed rule arrived at the Office of Management and Budget for review. Publication of this proposed rule is expected in June and will likely...more

Future OCR Audits Have Little in Common With Previous Round—Here’s How to Prepare

The HHS Office for Civil Rights (OCR) recently presented information about the new look of its Phase 2 audit program. The new audits will look little like the old ones, with OCR conducting the audits itself and focusing on...more

Government targets ‘risky business’ with free HIPAA assessment tool

Last week, the Office for Civil Rights of the U.S. Department of Health and Human Services released a toolkit for covered entities and business associates to use to perform a security risk assessment. The HIPAA Security Rule...more

No More Excuses: HHS Issues New HIPAA Tool for Small Businesses

Three U.S. Department of Health and Human Services (“HHS”) agencies, the Office for the National Coordinator for Health IT (“ONC”), in conjunction with the Office for Civil Rights (“OCR”) and the Office of the General Counsel...more

ONC’s Security Risk Assessment Tool Is Useful but Could Be Improved

The Office of the National Coordinator for Health Information Technology (ONC) released a Security Risk Assessment Tool (SRA Tool) on March 28. According to the User Guide for the SRA Tool, the Tool is designed to help small...more

FDA, ONC and FCC Report Outlines Proposed Health Information Technology Regulatory Strategy and Recommendations

On April 3, 2014, the U.S. Food and Drug Administration, in conjunction with the Office of the National Coordinator for Health Information Technology and the Federal Communications Commission, issued a draft report that...more

Global Food, Drugs, Medical Devices and Cosmetics Newsletter

Welcome - We are pleased to provide you with the Spring edition of the Global Food, Drugs, Medical Devices and Cosmetics newsletter. As stated in our inaugural issue, this newsletter provides updates on important...more

FDA, ONC, and FCC Issue Report on the Regulation and Oversight of Health IT Technologies

On April 3, 2014, the Food and Drug Administration (“FDA”) released its long-awaited report on a proposed framework for the regulation and oversight of health information technology (“health IT”). The report, developed in...more

Is Your HIPAA Compliance Program Going Out the Window with XP?

April 8, 2014 marks the end of Microsoft’s support for the Windows XP operating system, which means the end of security updates from Microsoft and the beginning of new vulnerability to hackers and other intruders into systems...more

New Round of HIPAA Audits To Begin Later This Year

The Department of Health and Human Services’ Office for Civil Rights (OCR) recently announced it will resume its HIPAA compliance audit program — launched as a pilot program in 2012 — on a permanent basis in 2014. In...more

Harvard Researchers Take FDA Approval of Implantable Cardiac Devices to Task

Based on new documents uncovered within the bowels of the Food and Drug Administration (FDA), researchers at Harvard University have joined voices with many FDA watchers to conclude the way most medical devices make it to...more

One Step Away: European Parliament Approves New Clinical Trials Regulation

On April 2, 2014, the European Parliament approved the new clinical trials regulation (the “Regulation”) for the European Union (“EU”), with 594 votes in favor, 17 opposed and 13 abstentions. The European Parliament approved...more

FDA Releases Draft Guidance on Section 503B Fees for Drug Compounding Outsourcing Facilities; Details Process for Paying and...

On April 1, 2014, the U.S. Food and Drug Administration (FDA) published notice of its Draft Guidance for Industry on Fees for Human Drug Compounding Outsourcing Facilities Under the Federal Food, Drug, and Cosmetic Act...more

Draft Guidelines for TeleICU Operations Released

The American Telemedicine Association released draft Guidelines for TeleICU Operations on March 28, 2014 and is seeking public comments through April 26, 2014. Practice guidelines can serve as a useful reference point...more

Tri-Agency Health IT Report Issued

Today, the three federal agencies charged with regulating components of health information technology (“Health IT”) issued their long-awaited Health IT Report: Proposed Strategy and Recommendations for a Risk-Based Framework...more

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