Regions

FDA Issues Draft Guidance Encouraging More Widespread Use of Electronic Health Record Data in Clinical Trials

On May 17, 2016, FDA issued Draft Guidance for Industry on Use of Electronic Health Record Data in Clinical Investigations (“Draft Guidance”).  This Draft Guidance builds on prior FDA guidance on Computerized Systems Used in Clinical Investigations and Electronic Source Data in Clinical Investigations, and provides information on FDA’s expectations for the use of Electronic Health Record (“EHR”) data to clinical investigators, research institutions and sponsors of clinical research on drugs, biologics, medical devices and combination products conducted under an Investigational New Drug Application or Investigational Device Exemption.

While the recommendations set forth in the Draft Guidance do not represent a significant departure from existing guidance, research sponsors, institutions and investigators should consider the extent to which their existing policies and procedures, template agreements, protocols and informed consent documents should be updated to incorporate FDA’s recommendations.

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What Issues Might the SEC and/or NLRB Have with Employee Confidentiality Agreements?

It is a common practice for employers to obtain a written agreement from employees to refrain from disclosing company trade secrets and other confidential and proprietary information. Such agreements are structured to be effective after an employee departs, as well as while he or she is actively employed. Confidentiality and non-disclosure agreements can be an important tool in an employer’s efforts to protect trade secret, business-sensitive, and other confidential information, but if they are not thoughtfully and carefully drafted, they could engender unwelcome scrutiny, or even enforcement action, from executive agencies, such as the U.S. Securities and Exchange Commission (“SEC”) and the National Labor Relations Board (“NLRB”). The SEC and NLRB have shown interest in confidentiality provisions even in the absence of an existing action or a complaint from the employee.

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OSHA’s Electronic Recordkeeping Rule: New Pitfalls for Employers

Our colleague Valerie Butera, a Member of the Firm at Epstein Becker Green, has a post on the OSHA Law Update blog that will be of interest to many of our readers in the technology industry: “OSHA’s New Electronic Recordkeeping Rule Creates a Number of New Pitfalls for Employers.”

Following is an excerpt:

On May 12, 2016, OSHA published significant amendments to its recordkeeping rule, requiring many employers to submit work-related injury and illness information to the agency electronically.  The amendments also include provisions designed to prevent employers from retaliating against employees for reporting injuries and illnesses at work.  The information employers provide will be “scrubbed” of personally identifiable information and published on OSHA’s website in a searchable format. …

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OSHA’s Electronic Recordkeeping Rule: New Pitfalls for Employers

Our colleague Valerie Butera, a Member of the Firm at Epstein Becker Green, has a post on the OSHA Law Update blog that will be of interest to many of our readers in the financial services industry: “OSHA’s New Electronic Recordkeeping Rule Creates a Number of New Pitfalls for Employers.”

Following is an excerpt:

On May 12, 2016, OSHA published significant amendments to its recordkeeping rule, requiring many employers to submit work-related injury and illness information to the agency electronically.  The amendments also include provisions designed to prevent employers from retaliating against employees for reporting injuries and illnesses at work.  The information employers provide will be “scrubbed” of personally identifiable information and published on OSHA’s website in a searchable format. …

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The Insolvency and Bankruptcy Code, 2016 – a brief snapshot

The Insolvency and Bankruptcy Code, 2016 (“Code”) has been passed by the Lok Sabha on May 5, 2016 and Rajya Sabha on May 11, 2016, and shall come into force, once, it receives the Presidential assent. The Code, seeks to consolidate and amend the existing laws on bankruptcy and insolvency matters and creates a unified legal framework for resolution of insolvency/bankruptcy issues in a time bound manner. 

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Ændringer i byggeloven

Folketinget har den 21. april 2016 vedtaget et lovforslag om ændring af byggeloven. Loven lemper bl.a. reglerne om byggeskadeforsikring, indfører en certificeringsordning i forbindelse med byggesagsbehandlingen og indfører en gebyrmulighed i byggesager.

Reglerne om byggeskadeforsikring bliver lempet i relation til udlejningsejendomme

Fremover undtages bygherren fra kravet om byggeskadeforsikring ved opførelse af udlejningsejendomme, og dermed bliver det frivilligt, om bygherren vil tegne en byggeskadeforsikring. Det er ejendommens tiltænkte anvendelse, der er afgørende for, om en ejendom er omfattet af undtagelsen.

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Ninth Circuit Approves Time-Rounding Practice – Employment Law This Week

One of the top stories featured on Employment Law This Week: The U.S. Court of Appeals for the Ninth Circuit reaffirms an employer’s time-rounding practice. A call-center employee in California recently brought a class action lawsuit against his employer for time-rounding practices. The employee claims that the policy caused him to be underpaid by a total of $15 over 13 months. Relying on a California Court of Appeals precedent, the Ninth Circuit found that the company’s facially neutral rounding policy—one that rounds time both up and down—is legal under California law. The employee also argued that he was denied payment for a total of one minute when he logged into call software before he clocked in. The Ninth Circuit found that the de minimis doctrine applied in this case, because identifying a single instance in order to provide payment would create an undue burden on the employer.

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Health Care Providers May Soon See a Twofold Increase in False Claims Act Penalties

In fiscal year 2015, the U.S. Department of Justice (“DOJ”) recovered more than $3.5 billion from False Claims Act (“FCA”) cases. A staggering $1.9 billion of that amount was recovered from health care providers who were alleged to have provided unnecessary care, paid kickbacks or overcharged federal health care programs.  While this amount may seem high, the drastic increases in FCA penalties expected this summer have the potential to skyrocket FCA recoveries in coming years. DOJ has not yet released the increased penalty amounts that would apply to FCA cases involving companies in the health care and life sciences industries, but penalty increases released this month by another agency, the U.S. Railroad Retirement Board (“Railroad Board),[1] seem to be a good indication of what providers can expect.

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NLRB May Make It Harder for Employees to Decertify Unions

Our colleague Steven M. Swirsky, a Member of the Firm at Epstein Becker Green, has a post on the Management Memo blog that will be of interest to many of our readers in the technology industry: “NLRB Looks to Make It Harder for Employees to Decertify Unions.”

Following is an excerpt:

National Labor Relations Board (NLRB) General Counsel Richard F. Griffin, Jr., has announced in a newly issued Memorandum Regional Directors in the agency’s offices across the country that he is seeking a change in law that would make it much more difficult for employees who no longer wish to be represented by a union to do so.  Under long standing case law, an employer has had the right to unilaterally withdraw recognition from a union when there is objective evidence that a majority of the employees in a bargaining unit no longer want the union to represent them. …

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Trade Union Reforms Become Law

The Trade Union Bill, introduced by the UK Government in 2015, has received Royal Assent and is now the Trade Union Act.

The Bill was introduced after the Government announced a series of reforms last year that it said aimed to ensure strikes would only be able to go ahead as a result of a clear and positive democratic mandate from union members. Under the Trade Union Act, industrial action will only be able to take place when there has been a ballot turnout of at least 50%.

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