SUMMARY

The last decade has seen the creation of complex genomic tests, sometimes as the outcome of tens of millions of dollars of research, designed from ground up to solve a recognized clinical problem. These tests, which range in price from $500 to $3000, are the “poster child” for the potential as well as the challenges when genomics and advanced bioinformatics are brought together and enter the clinic. According to a number of published studies, at least some tests in these categories can be net cost-saving in real-world scenarios, in addition to improving medical decision-making.

In March 2012, the local Medicare contractor for all California-based laboratories plans to launch an elaborate program for genomic test evaluation, coding, and pricing. This essay discusses major features of the program, as they have been released up to November 2011. The program is likely one of the most distinctive strategic policy efforts proposed by a Medicare contractor in the forty-five year history of the Medicare program. 

SUMMARY

This guide is intended to provide foreign business-people with an introduction to the basic kinds of laws and regulations that affect the conduct of business in the United States, and particularly in The Commonwealth of Massachusetts. The level of detail is varied, reflecting the nature of the legal areas discussed. For example, environmental law and taxation are subjects of detailed and technical regulation, while labor relations are governed as much by custom and practice as
by direct regulation.

The discussion under each heading is intended to provide only general guidance and is not an exhaustive description of all provisions of federal, state and local law with which a non-U.S. business operating in Massachusetts might be required to comply.

 

SUMMARY

Introduction

The core set of genetic test codes used by U.S. insurers and Medicare date to 1993. Only general information is conveyed by these codes to insurers – “DNA probe x 2.” They lead to payment for genetic tests based on a fixed price per genetic test step (such as “DNA probe x 2” or “DNA amplification x 3”). The payment was set using rules for the Medicare clinical laboratory fee schedule, rules which date to 1984. [more... ]

SUMMARY

An overview and summary tables of federal and state laws regulating data security privacy in the United States as of September 2011.

SUMMARY

Directors of nonprofit corporations owe fiduciary obligations to the corporation. They are bound by Massachusetts law to perform their duties as directors in good faith, in a manner reasonably believed to be in the best interests of the corporation, and with such care as an ordinarily prudent person in a similar position would exercise under similar circumstances. As stewards of the nonprofit corporation, directors are required (1) to act with care in their oversight and, (2) to keep the interests of the corporation paramount above their own personal interests when acting for, or on behalf of the corporation. These legal duties are known as the duty of care and the duty of loyalty.

SUMMARY

This volume summarizes related bodies of law – false advertising, commercial disparagement, and defamation – that govern the conduct of business communications. It sets forth elements, damages, and related defenses for each of these causes of action and suggests ways to reduce the risk of liability in business communications, advertising, and marketing. Related claims, such as trademark infringement, copyright infringement, and interference with contractual relations, are also addressed. Risk management procedures, a checklist for compliance training, and a sample complaint, answer and jury instructions are provided.

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SUMMARY

The Affordable Care Act (also known as the ACA) was enacted earlier this year culminating over a year of intense political negotiations, legislative drafting and numerous Congressional hearings over whether, and how, to comprehensively reform the nation's health care system.

SUMMARY

A year and a half has passed since Congress sought to make document productions and associated pre-production privilege review less costly and less burdensome with the passage of Federal Rule of Evidence 502. In this column, we examine the new rule, describe what parties can do to maximize their protection under the rule, and highlight the potential risks the rule has left unaddressed.

SUMMARY

MassChallenge is a recently created partnership designed to accelerate the development and success of high-growth, high-impact new businesses and to stimulate job creation across the Commonwealth and beyond. Foley Hoag LLP is proud to be a sponsor and supporter of this initiative. MassChallenge has launched a series of initiatives aimed at recruiting and cultivating entrepreneurs who are interested in entering the competition. A training seminar hosted on May 25 titled "Incorporating Your Startup" was presented by Foley Hoag lawyers Gil Arie, Mark Haddad, David Pierson and Paul Sweeney. The course covered the basics of incorporation from choosing a form of legal entity and deciding when to incorporate. Interested entrants can download the full presentation here.

SUMMARY

Executive Summary

This report explores the benefits that Talisman Energy Inc. (“Talisman”) might derive and the challenges it might encounter if it were to adopt a policy to secure the free, prior, and informed consent (“FPIC”) of indigenous peoples potentially impacted by its global operations. Talisman commissioned this report at the request of two responsible investors, Bâtirente and Regroupement pour la responsabilité sociale des entreprises (“RRSE”). The World Resources Institute (“WRI”), a think tank and thought leader on FPIC, was asked to provide a third party commentary on it. The scope of the report, as agreed by Talisman, the responsible investors, and WRI, includes the legal history of FPIC, the opportunities and challenges attendant to a FPIC policy, FPIC best practices, and guidance on FPIC policy language and implementation guidelines.

SUMMARY

For several major cancers, drug selection already pivots on biomarker results (e.g., trastuzumab for breast cancer, and gefitinib and erlotinib for lung cancer). Fast-paced advances in genomic and proteomic laboratory technologies could enable the widespread use of molecular testing before therapy selection in any field of medicine. This article describes two potentially large obstructions to such innovation. First, laboratory tests have traditionally been commodities with low prices, prices that matched the resources required to operate the laboratory technology itself.

SUMMARY

Contents

1. Exposure to Liability in the Hiring Process

2. Failure to Adequately Document Terms and Conditions of Employment

3. Misclassification Issues
    - Employee or Independent Contractor
    - Exempt or Non-exempt

4. Failure to Comply with Wage Payment Laws

5. Inadequate Protection of Intellectual Property

SUMMARY

Introduction

The insurance relationship is primarily one of contract, with the insurance policy as the principal source of the parties’ obligations. As with other types of insurance, the duties of the parties—and the consequences of breaching those duties—are affected by government regulation, primarily in the form of state statutes addressing insurer conduct. Another source of law affecting insurance obligations is the judiciary. As liability insurance disputes became a staple of the courts’ civil dockets during the second half of the twentieth century, recurring issues generated a significant body of common law. Nevertheless, in any study of the obligations of insurer and insured under liability coverages, there is no avoiding the oft-used insurer admonition, “Read Your Policy.”

SUMMARY

In March, President Obama signed an executive order lifting the Bush Administration restrictions on federal funding for human embryonic stem cell (HE S) research. The possibility of new federal funding opportunities, in combination with more than a decade of scientific advances in both embryonic and adult stem cell research, signal that stem cell-based therapies (“SCBT”) could soon be available for patients in a clinical setting. For those wishing to commercialize such therapies, it will be important to ascertain how the U.S. Food and Drug Administration (“FDA ”), which has regulatory authority over U.S. marketing of SCBT, will exercise this oversight.

This article is not intended to be an exhaustive dissertation on all laws and regulations pertaining to stem cell research, embryonic or otherwise.1 Rather, it discusses the controversial history of federal funding for stem cell research, and then focuses on regulations and guidelines likely to govern FDA approval of clinical applications of SCBT. It also discusses some of the recent recommendations included in the International Society for Stem Cell Research Guidelines in the context of U.S. application of those recommendations.  (continues...)

SUMMARY

In Massachusetts, charitable corporations, trusts and associations are not liable for more than $20,000 in damages for injuries (“torts”) caused by the organization while engaging in charitable activities. An organization will be categorized as charitable if “the dominant purpose of its work is for the public good.” Its activities will be characterized as charitable if they contribute directly to its charitable purposes. (more...)

SUMMARY

Information security — the discipline of protecting information found in paper documents, electronic files and emails — has become increasingly important in business. As reports of identity theft, data breaches and cybercrime have become more common, government has begun to call on businesses, both large and small, to take on new responsibilities for protecting sensitive information.

Responding to the rising tide of damaging security incidents, the federal government and the majority of states have enacted laws and regulations requiring individuals and companies to adopt comprehensive information security programs to protect sensitive information. (more...)

SUMMARY

A glossary of programs administered by the Treasury, the FDIC and the Federal Reserve.

Excerpt:

TARP, TALF, TGLP… Help!!! Ever since Congress passed the Emergency Economic Stabilization Act on October 3, 2008, the Secretary of the Treasury, the Federal Deposit Insurance Corporation (FDIC) and the Federal  Reserve have been working at a feverish pace to come up with solutions to the unprecedented crisis in the financial markets   continues...

 

Originally published in Bank Accounting & Finance.

 

SUMMARY

Trade secrets can be a valuable component of an intellectual property (IP) portfolio, whether as a complement to patents or as an alternative. Companies benefit from an IP portfolio that matches the unique benefits of trade secrets and patents to the types of information they seek to protect. Trade secret protection can be available immediately, without going through a government agent, whereas a patent is available only after an application to and approval by the government. And unlike patents, trade secrets provide IP protection of potentially infinite duration. Trade secret protection is also available for a broad array of information for which patents are not available.

SUMMARY

This chart shows a side-by-side comparison of Least Costly Alternatives, Inherent Reasonableness, and Functional Equivalence.

SUMMARY

The Employee Free Choice Act is proposed federal legislation that would greatly improve union chances of winning certification elections and would increase union membership throughout the country. Businesses have identified the EFCA as a serious threat and one that has a good chance of becoming law.

At this point, no one can predict whether the EFCA will pass as proposed, whether it will pass in an amended form, or whether it will pass at all. But, regardless, union organizing activity will likely increase in coming years due to the changed political environment, and employers need to be prepared.

I hope that you find the information in this booklet helpful, and please feel free to contact me if you have any questions.

Sincerely,

Jonathan A. Keselenko
Partner, Labor and Employment Department

Partner, Labor and Employment Department