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Health Care Update - December 2014 #5

In This Issue: - Hospital-Acquired Infections Hit Hospitals’ Bottom Line - Will a new treatment option for hepatitis C bring down health care costs? - Implementation of the Affordable Care Act -...more

New California Privacy Laws

California continues to lead the way in passing new or updating existing data protection legislation. The weekly disclosure of new data breaches that involve retail and other corporations has focused the general public...more

New Colorado Durable Medical Equipment Supplier License Requirements Become Effective 12-31-14

Effective December 31, 2014, durable medical equipment (DME) suppliers that do business in the State of Colorado will be required to have a license from the Colorado Secretary of State. In addition, as part of the license...more

Counties Seek To Implement Drug Disposal Ordinances

The Northern California County of Alameda has apparently begun to seek payment from select pharmaceutical manufacturers pursuant to the Alameda County Safe Drug Disposal Ordinance (Alameda County Code Chapter 6.53, §§...more

Office for Human Research Protections Extends Comment Period for Draft Guidance

The Office for Human Research Protections (OHRP) is extending the comment period for its Draft Guidance on Disclosing Reasonably Foreseeable Risks in Research Evaluating Standards of Care (Draft Guidance). Parties interested...more

Healthcare & Life Sciences Private Equity Deal Tracker: CardioDx Secures $35 Million in Financing

CardioDx, headquartered in Redwood City, Calif., is a molecular diagnostics company specializing in cardiovascular genomics. Participants in this round of financing included Alberta Investment Management Corp. and the...more

Federal Prosecutors Charge NECC Employees with Second Degree Murder: A Shot Across the Bow to Healthcare Companies Navigating...

Federal prosecutors charged the head pharmacist and the president of New England Compounding Center (NECC), a now-bankrupt Massachusetts compounding pharmacy, with second-degree murder and racketeering in the U.S. District...more

What Can You Expect in 2015 Regarding HIPAA Enforcement?

As of earlier this month, 1, 170 breaches involving 31 million records have been reported to the Department of Health and Human Services (HHS) since mandated reporting of breaches began in September 2009.  An increase in the...more

CMS Issues Additional Sunshine Act Guidance With Respect to Payments to Speakers at Continuing Medical Education Events

In a final rule published in the Federal Register on November 13, 2014, the Centers for Medicare and Medicaid Services (CMS) eliminated the federal Sunshine Act reporting exclusion for payments to physicians at continuing...more

Health Headlines: Also in the News - December 2014 #3

ONC Issues New Federal Health IT Strategic Plan –On December 8, 2014, the Office of the National Coordinator for Health Information Technology (ONC) released its Federal Health IT Strategic Plan 2015-2020 (Plan). The Plan...more

Health Alert (Australia) - December 22, 2014

In This Issue: Judgments; Legislation; and Reports. Excerpt from Judgments: New South Wales - 19 December 2014 – Dr Reid v Medical Council of NSW - [2014] NSWCATOD 152 - The Medical Council...more

Banking and Financial Services E- Note - December 2014

In This Issue: - Congress Move to Roll Back Bank 'Push-Out' Regulation Meets Anger - NCUA Calls for Retailers to Cover Data Breach Costs - Regulators Propose 8 Biggest Banks Increase Capital...more

Registration Begins for American Telemedicine Association’s New Accreditation of Online Medical Services

The American Telemedicine Association (ATA) is now accepting limited registrations for organizations that wish to gain ATA’s seal of approval for online medical services. Registration for the new Accreditation Program for...more

News from the Health Law Gurus™

Patient Medical Records Stolen from New Jersey Storage Facility – Tribeca Medical Center is notifying patients that their protected health information may be compromised. According to a privacy notice posted on Tribeca...more

Employer Liability for Employees’ Privacy Violations: What your organization should learn from Walgreens’ expensive lesson (hint:...

You may already have read the scintillating facts surrounding a jury award of $1.44 million (recently challenged unsuccessfully on appeal) against Walgreen Co. (Walgreens) following its pharmacist’s alleged inappropriate...more

Health Care E-Note - December 2014

In This Issue: - Cybersecurity Breaches Have Costly Impact on Health Care Industry - Many Patients Being Asked to Pre-Pay for Procedures - Health Care Providers Given Active Shooter Emergency Guidance -...more

Blog: OIG Report Encourages States to Explore Alternate Methods for Calculating Medicaid Supplemental Rebates

On December 12, 2014, the U.S. Department of Health & Human Services Office of Inspector General (OIG) published a report titled: “States’ Collection of Offset and Supplemental Medicaid Rebates” (OEI-03-12-00520). ...more

HHS Issues Notice of Proposed Rulemaking for Clinical Trials Registration and Results Submission to ClinicalTrials.gov

On November 19, 2014, the Department of Health and Human Services (HHS) published, for a 90-day public comment period, a Notice of Proposed Rulemaking (NPRM) for Clinical Trials Registration and Results Submission. The...more

On The Eighth Day of Privacy, Health Care Systems (Over)Shared Data

When is “sharing” too much of a good thing? And will it get worse for health care systems in 2015? Data sharing has become a point of sharp focus in the efforts to improve the quality and efficiency of health...more

Blog: No More Paper PIs? FDA Issues Proposed Rule on Electronic Distribution of Prescribing Information

Yesterday, the U.S. Food and Drug Administration (FDA) announced a proposed rule to require electronic distribution of the prescribing information intended for health care professionals (often called the “PI”) for human...more

CMS Announces Next Phase in Medicare DMEPOS Competitive Bidding Program

On December 11, 2014, CMS announced the bidding timeline for the Medicare Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) Competitive Bidding Program Round 2 Recompete and National Mail-Order...more

Latest HIPAA Settlement: Compliance is an Ongoing Process

The U.S. Department of Health and Human Services, Office for Civil Rights (OCR) issued its first settlement under new OCR Director Jocelyn Samuels earlier this month. This latest settlement serves as a reminder that a...more

Preliminary Injunction Order in Actavis Casts a Skeptical Eye Toward the “Hard Switch”

Last week, we briefly reported on the injunction granted by the U.S. District Court for the Southern District of New York in the New York Attorney General’s “product hopping” suit against Actavis and its subsidiary, Forest...more

Failure to take basic security measures may result in HIPAA penalties – 6 tips to keep up with updates and patches

Covered Entities and their Business Associates must comply with HIPAA’s Security Rule, or they may face substantial penalties. The Office of Civil Rights (OCR) recently shared a resolution agreement that emphasizes the...more

FDA Science Chief Reports Quicker Medical Device Clinical Trial Approvals

In a speech in Cambridge on December 11, 2014 (which was reported on in an article in the Boston Business Journal), Dr. Bill Maisel- the science chief of the U.S. Food and Drug Administration’s center to oversee approval of...more

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