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The 37th International Conference of Data Protection & Privacy Commissioners – Some Observations

The annual conference of the world’s data protection regulators is a three day exercise, with half of the conference being “closed door” for the regulators only, and the other half being a series of side meetings and...more

Promoting Antitrust Compliance – The Antitrust Division’s Subtle Shift Regarding Corporate Compliance: A Step Toward Incentivizing...

INTRODUCTION: A surprising feature of many corporate compliance programs is their limited emphasis on antitrust. Compliance efforts are a key feature of modern corporate governance initiatives, and it stands to reason...more

You Can Check Out Anytime You Want, But You Can Never Leave: FDA Import Detentions and Recommendations to Minimize Delays

In The Eagles’ song, “Hotel California,” Don Henley sings, “You can check out anytime you want, but you can never leave.” Life science companies can try to import all they want, but that doesn’t mean the products will make it...more

Australia Biotech Week showcases sophistication and growth

On October 9, Australia's biotech community completed its annual pilgrimage to Melbourne at the conclusion of Australia Biotech Invest 2015 and AusBiotech 2015. This year's conferences once again evidenced the primacy and...more

HHS OIG “Reminder” about Information Blocking & the Federal Anti-Kickback Statute

The HHS Office of Inspector General (OIG) recently released a “Policy Reminder” on how “information blocking” — defined by HHS as knowingly and unreasonably interfering with the exchange or use of electronic health...more

Beware the Feds: Emerging Risks to Health Care Executives Under the Yates Memo

Last month’s “Yates Memo” from the Department of Justice (DOJ) promises to be a game-changer in the world of government investigations and enforcement activity. While several U.S. Attorney Offices had been applying many of...more

The “Other” Safe Harbor: OIG Warns Healthcare Providers and Vendors Against Information Blocking and Federal Anti-Kickback...

For those of us who work in the privacy and security space this past week has been a whirlwind with focus on the ramifications of the European Court of Justice (ECJ) decision invalidating the EU-U.S. Safe Harbor Agreement....more

Hospira Moves to Dismiss Amgen’s BPCIA Claims in Epogen Biosimilars Suit

Last month, Amgen sued Hospira in Delaware under the Biologics Price Competition and Innovation Act of 2009 (BPCIA) over Hospira’s proposed biosimilar version of Amgen’s Epogen (epoetin alfa). In addition to claims for...more

Trans-Pacific Partnership: Compromise on Biologics Exclusivity Unclear

Earlier this month, a final agreement was reached on the Trans-Pacific Partnership that could provide for as little as five years of exclusivity for biologics. In recent months, it was reported that the biologics exclusivity...more

Bristol-Myers Squibb Pays $14 Million to SEC to Resolve China FCPA Offenses

On October 5, the SEC announced a settlement with Bristol-Myers Squibb to resolve allegations that the pharmaceutical company’s Chinese joint venture, BMS China, gave cash, jewelry, and other benefits to health care providers...more

FDA Releases First Wholesaler and 3PL Facility Licensure Data to the Public

Last week FDA took another important step in implementing the complex and interlocking provisions of the Drug Supply Chain Security Act (DSCSA). We have previously discussed the new Federal drug traceability requirements and...more

OIG Reports Insufficient Oversight Of HIPAA Compliance

The HHS Office for Civil Rights (OCR) must improve its oversight and enforcement of patient information privacy and security rules by “covered entities” and their business associates under the Health Information Portability...more

Is Your HIPAA Compliance Program Ready for the FTC?

Everyone in healthcare knows that the next round of HIPAA audits is coming. Covered entities and business associates have long been advised to review and update their HIPAA security risk analyses, have business associate...more

Four Clear Messages from Bristol Meyers Squibb FCPA Enforcement Action

The SEC’s FCPA enforcement action for $14.6 million against Bristol Meyers Squibb (“BMS”) in China provides a textbook example of how things can go wrong in China. For the compliance practitioner (as well as CEO and...more

Some Useful Insights from Steris-Synergy Merger Case

The Federal Trade Commission suffered a rare loss when, on Sept. 24, the U.S. District Court for the Northern District of Ohio denied its request for a preliminary injunction, despite having accepted the FTC’s “actual...more

Bristol-Myers Squibb FCPA Enforcement Action

Yesterday, the Securities and Exchange Commission (SEC) announced a Foreign Corrupt Practices Act (FCPA) enforcement action against Bristol-Myers Squibb Company (BMS) for the actions of the company’s joint venture (JV) in...more

OCR announces launch of Phase 2 of HIPAA audits

Although the Office for Civil Rights (OCR) has indicated in the past that it would start its next round of HIPAA audits, apparently it means business now. In the wake of an Inspector General report that the OCR was merely...more

Blog: HHS To Launch New HIPAA Audits in Early 2016 in Response to OIG Reports

The Office of Inspector General (OIG) of the U.S. Department of Health and Human Services (HHS) issued two reports yesterday calling for the HHS Office of Civil Rights (OCR) to strengthen its Health Insurance Portability and...more

It’s About Time! 10 Key (Needed) Changes Proposed to the Human Subjects Protection “Common Rule”

The world has changed drastically since 1991 when Operation Desert Storm was underway; the USSR crumbled; Prince Charles and Princess Diana separated; the World Wide Web was born; gas cost $1.14; and the Dow peaked at 3168....more

Fitbit Agrees to Sign Business Associate Agreements and Take on HIPAA Compliance

Is your Fitbit data covered by HIPAA? It depends upon where you got it (kind of). If you go to the store and pick up a Fitbit on your own, the data it generates is governed by the user agreement that you click through...more

Trustee Alert – Medical Identify Theft On the Rise

The increased use of electronic medical records and breaches of that data by computer hackers or handling errors by insurers and providers has increased medical identity theft in recent years. This increase reemphasizes the...more

FCC Guidance on Cellphones Puts the Squeeze on Medical Debt Collectors

In July, the FCC released an order it touted as strengthening “consumer protections against unwanted calls and texts.” It was a series of rulings based on the Telephone Consumer Protection Act meant to clarify the use of...more

Stolen Laptop Bag Leads to $750,000 Fine for Oncology Group

On September 2, 2015, the U.S. Department of Health and Human Services Office for Civil Rights (OCR) announced a substantial settlement with an Indiana-based oncology group, Cancer Care Group, P.C. (CCG). Under the terms of...more

Crafting a more realistic business associate agreement

According to a recent survey by KPMG, eighty percent (80%) of health care executives report that their information technology systems have been compromised by cyber attacks. Most healthcare institutions, the survey found,...more

True Health Diagnostics Makes Offer to Acquire Health Diagnostic Laboratory

True Health Diagnostics, based in Frisco, Texas, has offered to acquire Health Diagnostic Laboratory (HDL), based in Richmond, Va., for $32 million, according to a Richmond Times Dispatch report....more

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