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On April 24, 2014, the Food and Drug Administration (FDA) issued its long-awaited proposed regulations (Deeming Regulations) to bring electronic cigarettes, cigars, pipe tobacco, water pipe (hookah) tobacco, dissolvables and nicotine gels (Newly Covered Products) under the agency’s tobacco regulatory authority. The Deeming Regulations would subject Newly Covered Products to ... Read More »
Category Archives: Healthcare law
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Insurers nationwide continue to drop medical providers from medicare advantage plans
February 14, 2014
Since last fall, tens of thousands of physicians, medical practices and pharmacies nationwide, and their patients, have received notifications from some of the country’s largest Medicare Advantage plan providers, including health insurance giants UnitedHealthcare (UHC) and Humana, that the physicians, and entire provider groups, will be terminated from the insurers’ ... Read More »
OSHA Proposes Increased Obligations to Report Injury and Illness Data
December 20, 2013
The Occupational Safety and Health Administration (“OSHA”) issued a press release on November 7, 2013 announcing that it is proposing a rule that would increase the obligations of certain establishments to report injury and illness data. Read More »
FDA Quickly Leverages its Jurisdiction over Compounding Pharmacies
December 18, 2013
Within one week of President Obama’s signing a law that will give the U.S. Food and Drug Administration (FDA) partial jurisdiction over compounding pharmacies, the FDA has taken important action that will effectively change how the industry is regulated. Read More »
U.S. Senate approves the Drug Quality and Security Act
December 5, 2013
On November 18, 2013, the U.S. Senate, by voice vote, passed the Drug Quality and Security Act ( the “Act”) (H.R. 3204), marking the culmination of a nearly decade-long effort by many in the drug and pharmacy industry to clarify and strengthen both the regulatory framework for compounding pharmacies and ... Read More »
Expanded HIPAA Privacy Rules Impose Requirements on Non-Healthcare Businesses in Possession of Medical Records
November 19, 2013
On September 23, 2013, tough new privacy regulations under the Omnibus Final Rule (Omnibus Rule) update to the Health Insurance Portability and Accountability Act of 1996 (HIPAA) went into effect. Healthcare providers and others that fall under the category of healthcare Business Associates (BA) can expect increased levels of enforcement ... Read More »
New Wellness Program Rules for 2014
November 5, 2013
Employers continue to look for ways to manage the cost of employee health care coverage as they navigate the turbulent waters of healthcare reform, and wellness programs continue to be a popular strategy. Read More »
Banks are Increasingly Becoming Targets of Americans with Disabilities Act ATM Class Action Lawsuits
October 28, 2013
Amendments to the Americans with Disabilities Act (ADA) require ATMs to include audio-based capabilities for all features on the machine. For example, if standard users are able to obtain transaction histories or account balances, then blind customers must be able to obtain the same information using the text-to-speech mode. ATMs ... Read More »
Factors deciding on the amount of compensation due to medical mistakes in the view of judicial decisions
June 14, 2012
The court, while determining an amount of the compensation due to medical mistake committed by the physician, first of all evaluates a type of the Read More »
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by: Kalwas & Partners
in Healthcare law, Poland
Few remarks on rights of patients suddering from medical mistakes
May 24, 2012
In a current legal status patient suffering from medical error is entitle to seek, in one civil proceedings, compensation for the harm caused Read More »
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by: Kalwas & Partners
in Healthcare law, Poland
Measures of the patients’ legal protection in course of clinical tests of medicines
May 11, 2012
A total anonymity and strict protection of patients’ data are measures of patient’s legal protection while taking part in clinical tests of medicines Read More »
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by: Kalwas & Partners
in Healthcare law, Poland
Legal amendments to various laws on disability matters
May 10, 2012
Act II of 2012 (‘the Act’) addresses the rights of disabled persons under Maltese law aiming to ameliorate existing laws combating discrimination on the Read More »
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by: EMD Advocates
in Healthcare law, Malta
Adoption of the drug policy reform in Slovakia
February 16, 2012
On September 13, 2011 Slovak Parliament adopted a new Act on Drugs and Medical Devices (hereinafter „the Law“) which, replaced Act No.140/1998 Coll. The Law became effective as of 1st December 2011. Read More »
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by: alianciaadvokatov
in Healthcare law, Slovakia
Price cuts and public discounts in the Turkish pharma industry
January 27, 2012
One of the most controversial developments in the Turkish pharma industry, in 2011, has undoubtedly been the increase in public discounts of reimbursement and decrease of prices of pharmaceuticals. Read More »
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