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Alert: Key Regulatory Considerations for Digital Health Companies

Digital health is a growing field that promises improved patient education, wellness, engagement, access to care, and outcomes, among other things. However, with these new technologies come unique regulatory concerns that...more

Parties Continue to Challenge the FCC’s July 2015 Declaratory Ruling and Order

On September 4, 2015, both Vibes Media, LLC and Rite Aid Hdqrtrs. Corporation filed petitions for review of the FCC’s July 10, 2015 Declaratory Ruling and Order with the United States Court of Appeals for the District of...more

Health Alert (Australia) - September 7, 2015

In This Issue: -Judgments; Legislation; and Reports -Excerpt from Judgments Australia. High Court 2 September 2015 - AstraZeneca AB v Apotex Pty Ltd AstraZeneca AB v Watson...more

Inevitable Disclosure Doctrine Held Inapplicable To Failed Business Transaction

An Illinois appellate court recently rejected applying the inevitable disclosure doctrine in a trade secret misappropriation spat arising out of a failed business transaction....more

FCC Releases Guidance on Autodialing and Pre-Recorded Voice Calls to Wireless Phone Numbers

This past July, the Federal Communications Commission (“FCC”) released a ruling (the “Ruling”) interpreting the Telephone Consumer Protection Act (“TPCA”) restrictions on certain communications to wireless telephone numbers....more

St. Elizabeth’s Medical Center Pays $218,400 to Settle Alleged HIPAA Security Case Stemming from Use of Cloud-Based Document...

Alleged HIPAA Violations Resulted from Medical Center’s Failure to Risk Assess Internet-Based Document Sharing Application and Inadequate Breach Response. The US Department of Health and Human Services (HHS) Office for...more

Marginal Evidence of Customer Diversion Won’t Support a Price Discrimination Claim

In Cash & Henderson Drugs, Inc v. Johnson & Johnson, Case No. 12-4689 (2nd Cir. Aug. 27, 2015), the Second Circuit upheld a summary judgment in favor of defendant pharmaceutical manufacturers accused of price discrimination....more

Mechanical Ventilation Innovation Challenge

According to press releases, the American Association for Respiratory Care (AARC) and Edison Nation Medical have partnered to search for innovations for improving the process, outcomes, and comfort for patients requiring...more

Health Alert (Australia) - August 24, 2015

In This Issue: - Judgments; Legislation; and Reports. - Excerpt from Judgements: Victoria 17 August 2015 - Bourke v Coroners Court [2015] VSC...more

Another FTC Conduct Case to Bolster Generic Drug Competition: Pharmaceuticals Charged with Illegal Non-Compete for Generic ADHD...

The Federal Trade Commission’s (“FTC” or “Commission”) ever-expanding list of enforcement actions to preserve competition for generic pharmaceuticals just grew in a new direction. This week, two generic pharmaceutical...more

The Top Six Things You Need to Know About the Internet of Things: A Legal Perspective

IoT is discussed in the media more and more frequently. It has important social, economic and legal implications, most of which are yet to be fully understood. The following sets out a brief list of things you should...more

Identifying the likely beneficiaries of an emerging biosimilars market

Financial analysts have predicted that over the next five years, biosimilars will be a $10 billion market, so it is understandable why considerable attention and investment is being made in this space. However, while there is...more

“Everything Old is New Again” – Issues in Recent Cyber Insurance Litigation

Early days still for coverage litigation about cyber risks – whether under cyber insurance policies or other types of policies. This is not surprising given the relatively short history of cyber risks and even shorter history...more

The Supreme Court Addresses Scope of Section 11 Liability for Statements of Opinion

As the Supreme Court recently explained in Omnicare, Inc. v. Laborers District Council Construction Industry Pension Fund, 135 S. Ct. 1318 (2015), that distinction is significant when it comes to liability under Section 11 of...more

Massachusetts Hospital Agrees to Six-Figure Payment Related to HIPAA Compliance Allegations

St. Elizabeth’s Medical Center (SEMC), a tertiary care hospital based in Brighton, Mass., agreed to pay $218,400 to address deficiencies in its HIPAA compliance activities. The SEMC settlement continues a pattern of...more

Medicaid managed care proposed rule expands program integrity obligations

On June 1, 2015, the US Centers for Medicare & Medicaid Services (“CMS”) published its proposed rule on Medicaid managed care (CMS-2390-P). As noted in our two earlier advisories, which provided an overview of the proposed...more

Alert: Second Circuit Rules that "Product Hopping" May Constitute Unlawful Monopolization; Pharmaceutical Companies are Likely...

Recent antitrust challenges to pharmaceutical companies' efforts to transition patients from drugs nearing the end of their patent life to next-generation drugs have increased the risk of pursuing such "product hopping"...more

Blog: General Wellness Products: Will the FDA Regulate Your Medical App or Device?

In January 2015, the U.S. Food and Drug Administration (FDA) released its draft guidance on general wellness products, a reassuring indication that the FDA will focus its efforts on regulating higher risk products rather than...more

How to Keep What is Yours: Practical Considerations for Healthcare IT Protection

One of the worst kept secrets is the experienced and expected growth in healthcare IT. In 2013, over $650 million was invested into healthcare IT companies, and the trend is continuing to grow. Combined with the fact that...more

Is Your Pharmacy Ready for Drug Supply Chain Integrity?

Beginning July 1, 2015, most pharmacies in the U.S. will be required to have systems in place to receive transaction information regarding the prescription drugs they purchase from suppliers. The requirement stems from a...more

Gavel to Gavel: Protect your data

The ever-increasing expense of corrective actions taken by companies after data breaches is often publicized. What’s not as apparent, or as publicized, are steps companies can take that may reduce the costs and the likelihood...more

Cloud Computing Contracts Top Issues for Healthcare Providers

In this Issue: - Summary - Overview - Cloud - Use - Security - Privacy - Functions - Availability - Performance - Location - Services -...more

Life Sciences Spotlight - Asia Pacific - Issue 5, 2015

In This Issue: - Harper Review Dispenses Important Recommendations For The Life Sciences Sector - Pharmaceutical Patent Term Extensions In Australia - PRC Anti-Corruption Regime 101 - Revisions To The Medicines...more

Blog: Changes to Sunshine Law Included in Proposed 21st Century Cures Legislation

As we recently discussed, a bipartisan group of representatives from the House of Representatives’ Energy and Commerce Committee released a new discussion draft of the 21st Century Cures initiative (Legislation) that seeks to...more

HIPAA Enforcement Remains a Concern for Providers of All Sizes

On Monday, April 27, 2015, the Department of Health and Human Services ("HHS"), Office for Civil Rights ("OCR") announced a settlement with Cornell Prescription Pharmacy ("Cornell"). Under the Resolution Agreement, Cornell...more

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