Health Science, Computers & Technology

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China’s State Council Announces Major Policies to Reform the Pharmaceutical Industry

China will launch further reforms in the pharmaceutical sector as part of the healthcare reform initiatives announced by the State Council in its February 9, 2017 Circular on Several Opinions Concerning Further Reforms of the...more

Tokyo Dispute Resolution & Crisis Management Newsletter – February 2017

Product Pricing and Antitrust Law in the United States - A recent US court action by a Japanese company in respect of a competitor’s volume discounts - Introduction - The current position in the US on the rules...more

Expanding Duties and Eroding Protections for Medical Device Manufacturers

Earlier this month, the Washington Supreme Court saddled medical device manufacturers with a new duty to warn under Washington law—the duty to warn hospitals about potential risks their products may pose—and eroded exemptions...more

Non-Physician Learned Intermediaries

One of us was asked a question the other day that we couldn’t answer immediately. “Does the learned intermediary rule apply to a physician’s assistant?” We didn’t remember any cases actually deciding that issue. So we did...more

Want to Know Why Memorial Healthcare Systems Is Paying HHS OCR $5.5 Million?

On February 16, 2017, HHS OCR announced that Memorial Healthcare Systems (MHS) had paid the U.S. Department of Health and Human Services (HHS) $5.5 million to settle potential violations of HIPAA’s Privacy and Security Rules...more

FDA Hardens Its Stance on Intended Use and Off-Label Use and Industry Responds

From 2015 to 2016, FDA appeared to open the door to loosening the standards around intended use and off-label use, but recent rule-making and public comments suggest that FDA is becoming more sclerotic instead of flexible....more

Major Effects of Revised Common Rule on Regulation of Clinical Research in New York

On January 19, 2017, the U.S. Department of Health and Human Services (HHS), together with 15 other federal Departments and Agencies, issued a final rule to revise and modernize the federal Policy for the Protection of Human...more

News from the Vermont State House - An analysis from DRM's Government & Public Affairs Team - February 2017 #2

Governor’s $35 Million Housing Bond Discussed in Ways and Means Committee - Executive Director Gus Selig of the Vermont Housing and Conservation Board revealed some of the details this week behind the $35 million bond...more

Modernization? SAMHSA Falls Short in Updating 42 C.F.R. Part 2

On January 18, 2017, the Department of Health and Human Services Substance Abuse and Mental Health Services Administration (“SAMHSA”) published a final rule amending 42 C.F.R. Part 2 (“Part 2”), with an effective date that...more

New HHS Secretary Delays Effective Date of Part 2 Final Rule

We previously reported that the 30 year old regulations (last updated in 1987) relating to the disclosure of substance abuse treatment information has been updated by SAMHSA to bring it into the modern world of electronic...more

HIPAA for HR - Some Good News for Employers

The Health Insurance Portability and Accountability Act of 1996 (HIPAA) is a federal law that was enacted to ensure protection of individuals’ protected health information (PHI). The Standards for Privacy of Individually...more

Advocating for Patient Safety: Coalition for Patient Vision Care Safety submits comments in response to FTC Proposed Rule...

The Coalition for Patient Vision Care Safety (“Coalition”) is a group of health care providers, medical device manufacturers and academic institutions dedicated to ensuring the safe and appropriate use of contact lens so that...more

Health Care E-Note - Februaury 2017

Ransomware: A Reportable Breach? In the past several years, a huge increase has occurred in the number of electronic attacks in the United States using ransomware, a form of malware that targets and encrypts critical...more

Six Key Changes to the Common Rule

On January 19, 2017, sixteen federal agencies, including the Departments of Health and Human Services and Labor, published the first revision to the federal regulations governing the protection of human subjects participating...more

Technical Noncompliance with HIPAA Can Lead to Big Penalties

As discussed in prior client alerts, the Office of Civil Rights (OCR), the agency charged with HIPAA enforcement, has increased HIPAA compliance initiatives in recent months and is poised to continue its enforcement...more

TrumpCare: The Pharmaceutical Industry and FDA

Hope in the Midst of Uncertainty - The New Year ushered a period of uncertainty for the pharmaceutical industry. We face the beginning of the Trump Administration and a Congress with both houses controlled by Republicans...more

FDA Hits “Pause” on Regulation of LDTs

On January 13, 2017, the U.S. Food and Drug Administration (FDA) issued a Discussion Paper on Laboratory Developed Tests (LDTs) (LDTs) (Discussion Paper). The Discussion Paper follows FDA’s late 2016 announcement that,...more

California Rule Change: Drug Labeling Requirements

Recently, the California Board of Pharmacy announced changes to its drug labeling rules that will take effect on April 1, 2017. The Board of Pharmacy amended Section 1744 of Article 5 of Division 17 of Title 16 of the...more

Cybersecurity 2017: The Year in Preview

Introduction - Cybersecurity was a prominent factor in 2016 in all aspects of government, business and personal affairs. Russian and other foreign national hacking has the potential to spark a new form of cold...more

What Is “Product Liability”?

We’re serious – we’re not planning to give a flip answer like “an extortion racket.” No, it’s more like law school, where a first-year contracts professor began with the question “What is Chicken?” (Hint – that’s discussed...more

Health Alert (Australia) February 13, 2017

In This Issue: - Judgments; Legislation; and Reports. - Excerpts from Judgments: Commonwealth. Federal Court 3 February 2017 - Australian Nursing and Midwifery Federation v Royal Children's...more

Briefing Complete in Appeal in Amgen v. Apotex

The parties in Amgen v. Apotex have completed briefing in Amgen’s appeal to the Federal Circuit from the district court’s judgment of noninfringment. As we have previously reported, in September 2016 the District Court for...more

Blog: Enforcement Trend: Patient Assistance Programs

Multiple pharmaceutical companies have disclosed the receipt of subpoenas from various U.S. Attorney’s offices, including Massachusetts and the Southern District of New York, related to the companies’ patient assistance...more

The Anthem Breach – A Retrospective (Part II)

We published Part I of our “Anthem Breach Retrospective” in January 2017. Coincidentally, at around the same time several plaintiffs in one of the earliest filed cases arising out of the Anthem data breach voluntarily asked...more

HHS Issues Final Revisions to the Common Rule – New Protections for Human Research Subjects

On January 19, 2017, the U.S. Department of Health and Human Services (HHS) and fifteen other Federal Departments and Agencies issued a final rule to update “Federal Policy for the Protection of Human Subjects,” also known as...more

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