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The Office for Civil Rights (OCR) of the Department of Health and Human Services today proposed an expansion of the rights of individuals to obtain reports from health providers and insurers about how their protected health information (PHI) is used.1 The draft regulations will require health providers and insurers (called “Covered Entities”) to provide more data faster and in a variety of formats as requested by individuals ...

The Centers for Medicare and Medicaid Services (CMS) announced the creation of so-called “Pioneer ACOs” on May 17 in an attempt to blunt heavy criticism over the draft regulations on Accountable Care Organizations (ACOs) issued on March 31, 2011 (the “Draft Regulations”).1 The Draft Regulations have been criticized due to their burdensome data collection requirements, large start-up costs, uncertain savings, possible losses and troublesome governance mandates ...

Southwest Health Alliance (“Southwest”), an independent practice association with approximately 900 member-physicians, has agreed to a proposed order recently entered by the Federal Trade Commission (“FTC”) settling charges that it engaged in anticompetitive conduct in its dealings with insurers and other payors for the provision of physician services (collectively, “insurers” or “payors”) ...

A former GlaxoSmithKline attorney, Lauren Stevens, was acquitted on May 10 of all criminal charges stemming from her response to an FDA investigation. The acquittal, ordered by U.S. District Judge Roger W. Titus, is a stunning defeat for the government’s anti-fraud enforcement measures. The judge also severely rebuked the government’s efforts in the matter, stating the case should never have been prosecuted. Had she been convicted, Stevens would have faced a prison term of up to 60 years ...

Haynes and Boone, LLP | April 2011

On April 18, 2011, the Centers for Medicare and Medicaid Services (CMS) began the attestation phase under its $27 billion Medicare EHR Incentive Program. Incentive payments for the meaningful use of electronic health records (EHR) will begin in May 2011 and will continue over the next several years. Eligible professionals (i.e ...

Haynes and Boone, LLP | April 2011

Accountable Care Organizations (ACOs) will face large start-up costs under proposed rules issued on March 31, 2011 by the Centers for Medicare and Medicaid Services (CMS), with an uncertain outlook for savings and even possible losses. An ACO is an organization of health care providers that agrees to be accountable for cost, quality and the overall care of Medicare beneficiaries who are assigned to it ...

How is health care in your jurisdiction organised? The basic principles of the organisation of the health-care system are governed by Act CLIV of 1997 (the Health-care System Act), more specifically by sections 141 et seq. Pursuant to section 141, the state is ultimately responsible for the state of health of the population, and for the creation of a system that protects, promotes and – if necessary – restores it ...

Haynes and Boone, LLP | March 2011

The Office for Civil Rights (OCR) of the U.S. Department of Health and Human Services has recently announced two significant enforcement actions against health care providers for violating the HIPAA Privacy Rule. In the first matter, Cignet Health Care of Prince George’s County, MD was fined $4.3 million for failure to provide patients with access to their health records and for failing to cooperate with the ensuing OCR investigation ...

The situation is this: you represent a manufacturer in a tort dispute.  During discovery, plaintiffs notice a Rule 30(b)(6) deposition of your client’s representative, but elect to forgo the deposition in exchange for negligible admissions filed by your client.  Discovery has closed.  The trial date is looming ...

MinterEllison | February 2011

Alternative dispute resolution benefits the public no matter what the outcome Attorney-General Robert McClelland continues to pus alternative dispute resolution after launching the report A Strategic Framework for Access to Justice in the Federal Civil Justice System late last year. One of its main recommendations is to encourage Commonwealth agencies to use ADR ...

Shoosmiths LLP | February 2011

The majority of disputes are settled before trial, and an increasing number are settled before proceedings are issued. The Civil Procedure Rules that provide the framework for litigation in England and Wales encourage parties to consider alternative ways to resolve their differences. There are a variety of techniques that can be utilised to achieve an early and cost effective settlement. Collectively, these are known as ADR ...

Gianni & Origoni | February 2011

The AGCOM (the Italian Media Authority) has recently published (on December 28th, 2010) two resolutions concerning the broadcasting services of audio and/or video contents (so-called “audiovisual media services”) in “linear” mode (“streaming” or “simulcast” services: Resolution n ...

Lavery Lawyers | February 2011

HARMONIZATION OF CLINICAL RESEARCH CONTRACTS IN QUEBEC OLGA FARMAN and MARIE-ÈVE CLAVET [email protected] [email protected] Over the past few decades, a high-quality system of research and innovation has been built in the Province of Quebec. The contractual research conducted by university-affiliated health-care institutions in Quebec has become a fundamental scientific, economic and social activity ...

Delphi | December 2010

A new version of the well-known International Chamber of Commerce (ICC) Incoterms® becomes effective on 1 January 2011. EXW, FCA, DDP, FOB and CIP – are some of the three-letter abbreviations of Incoterms® commonly found in sales and delivery agreements around the world ...

Delphi | December 2010

In Sweden, the directive has been implemented through amendments to the Medical Devices Act (1993:584), and through the regulation which the Medical Products Agency has issued in connection with this Act and the directive. The revised directive contains some clarifications but also some news ...

Shepherd and Wedderburn LLP | November 2010

The word litigation usually strikes fear into the hearts of the business community.  Litigation can be time-consuming and expensive.  Badly-managed litigation is a very painful experience indeed.  Managing litigation risk is therefore of huge importance for businesses.  But the challenge doesn’t start at the Court door ...

Hunton Andrews Kurth LLP | October 2010

  Hunton & Williams announced today the launch of its new website — the Hunton & Williams Health Care Reform Center,  huntonhealthcarereform.com ...

Van Doorne | September 2010

The hospital has lost lengthy legal proceedings about the uninsured patients from the governments of the Netherlands Antilles and Curaçao. The governments are not obligated to write a “blank check”, as it were, for the costs Sehos had to incur for uninsured persons that cannot be recovered, according to judge Van Schendel yesterday ...

ALRUD Law Firm | August 2010

Dear Sirs, On August 2, 2010 the Federal Law “On the alterations to the Arbitrazh Procedural Code of the Russian Federation” (“The Law”) was published ...

Haynes and Boone, LLP | July 2010

The U.S. Department of Health and Human Services, the U.S. Department of Labor and the U.S. Department of Treasury have released another set of interim final regulations (the “IFR”) regarding the coverage of preventive care without cost sharing. As with all guidance, the IFR cannot be considered in isolation ...

MinterEllison | June 2010

A new feature of the civil justice reform system came into effect on 1 January 2010, nine months into the revamp. Steven Yip and James Yeung report that the introduction of mediation, as prescribed by Practice Direction 31 ('PD 31'), is expected to have a profound impact on the way parties conduct cases ...

Dykema | June 2010

In 2010, the legal services industry—and for that matter almost every industry—faces a new landscape that requires not only a different way of thinking but also a different way of doing business to ensure short-term survival and longterm success ...

Shoosmiths LLP | May 2010

Shoosmiths - EnglandWhat is disclosure? It is the stage of a dispute when each party is required to disclose to the other party the documents relevant to the issues in dispute. It normally takes place after each party has set out its position in their statement of case ...

Shoosmiths LLP | April 2010

The music, film and broadcast industries look set to get the robust protection from illegal peer-to-peer (P2P) file-sharing they crave, as the Digital Economy Bill moves closer to becoming law. It passed its third reading at the House of Commons on 7 April ...

Gianni & Origoni | April 2010

Legislative Developments In July 2009, new rules came into force in Italy concerning class actions brought by consumers and final users who are the victims of unfair trade practices or anti-competitive conduct. Under the new rules, collective damages actions may be brought either by individual class members or by associations empowered by them or committees of which they are members for claims based on breaches of competition law ...

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