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|Are You Prepared to Deal with Potential Exposure to Ebola in the Workplace?|
Bennet D. Alsher, Amy R. Turci; Ford & Harrison LLP;
October 17, 2014, previously published on October 14, 2014Executive Summary: With the diagnosis of the second Ebola case in the United States on October 12, 2014 - one in which a healthcare worker contracted the lethal disease while performing her job duties - U.S. employers are examining what necessary precautions should be taken to control and prevent...
|Telemedicine Advances Allow Remote Patient Care|
Sigrid C. Haines; Lerch Early Brewer Chartered;
October 17, 2014, previously published on September 25, 2014The field is changing for the use of remotely-provided medical services. While the possibility of remotely-provided medical services received attention in the press some years ago, it has been slow to become a reality. Various issues have contributed to its slow adoption, including the need for...
|Commercially Confidential Information at Risk: The European Medicines Agency Issues Disclosure Policy|
Christian B. Fulda; Jones Day;
October 16, 2014, previously published on October 2014As if the fight for reasonable returns on investment into drug development, currently exemplified by the discussion on the pricing of innovative products, is not enough, the pharmaceutical industry is facing one of its biggest challenges in Europe: the protection of commercially confidential...
|OIG Seeks Comment on Recently Published Proposed Rule Expanding Anti-Kickback Safe Harbors|
Lynsey Morris Barron, Richard H. Deane, Gerald M. Griffith, Rebekah N. Plowman, Stephen G. Sozio; Jones Day;
October 16, 2014, previously published on October 2014The federal Anti-Kickback Statute ("AKS") criminalizes the solicitation or payment of remuneration in order to induce business that is reimbursable under the Medicare and/or Medicaid programs, such as kickbacks, bribes, and certain rebates. The U.S. Department of Health and Human Services...
|FDA: Industry Must Address Cybersecurity Risks for Medical Devices.|
Theodore P. Augustinos, Sharon A. Blinkoff, Ellen Marie Giblin, Mark E. Schreiber, David S. Szabo; Edwards Wildman Palmer LLP;
October 16, 2014, previously published on October 2014On October 1, 2014 the U.S. Food and Drug Administration finalized guidance on recommendations to manufacturers for managing cybersecurity risks to better protect patient health and information. The purpose of the guidance is to encourage manufacturers to consider possible cybersecurity risks while...
|Hospice Industry Will Face Stricter Scrutiny Under New Law Aimed at Post-Acute Care Data Standardization|
Lisa A. Estrada, Asha M. Natarajan; Foley & Lardner LLP;
October 15, 2014, previously published on October 8, 2014President Obama signed the “Improving Medicare Post-Acute Care Transformation Act of 2014” or the IMPACT Act of 2014 (the Act) on October 6, 2014. The new law is broadly focused on requiring all post-acute care providers to adopt standardized data protocols for patient assessment,...
|Proposed Rule Issued by OIG Realigns Its Enforcement Views with Health Care Reform Goals|
Theresa C. Carnegie, Thomas S. Crane, Carrie A. Roll, Stephanie D. Willis; Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.;
October 15, 2014, previously published on October 9, 2014Fridays never seem to be slow in the health care regulatory world. On Friday, October 3rd, the HHS Office of the Inspector General (OIG) issued a highly anticipated proposed rule (the Proposed Rule) that provides amendments to the Anti-Kickback Statute’s regulatory safe harbors (AKS Safe...
|Supreme Court Holds Health Care Professional Engaged to Provide an Independent Medical Records Review Owes No Duty of Care to Patient.|
Nicole J. Benjamin; Adler Pollock & Sheehan P.C.;
October 15, 2014, previously published on September 24, 2014In a case of first impression, the Rhode Island Supreme Court held that a doctor who was hired by a third party to provide an opinion about a patient based solely on his review of the patient’s records did not owe a duty of care to the patient. Consequently, the doctor cannot be held liable...
|Does the Medicare Telehealth Parity Act of 2014 Stand a Chance?|
Nathaniel M. Lacktman; Foley & Lardner LLP;
October 15, 2014, previously published on October 9, 2014“Telehealth saves money and helps save lives. By expanding telehealth services, we can make sure the best care and the best treatments are available to all Americans, no matter where they live.”
|CMS Rolls Out Open Payments in Effort to Increase Transparency and Accountability|
Loeb Loeb LLP;
October 14, 2014, previously published on September 2014CMS published its first round of data as laid out in the Sunshine Act, and stakeholders, including the American Medical Association, are concerned.