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|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...
|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...
|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...
|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,...
|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.”
|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...
|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.
|FDA Sends Warning Letters to Companies that Made Claims on Social Media that their Products Treat, Cure Ebola, Marking the First Time the Agency Singles Out Pinterest|
Loeb Loeb LLP;
October 14, 2014, previously published on September 2014The FDA sent warning letters to three companies making claims on social media platforms that their products are possible treatments and cures for the Ebola virus. This marks the first time that the FDA has taken notice of claims made on Pinterest.
|Managing Social Media Risks in Healthcare|
Laura R. Hammargren; Mayer Brown LLP;
October 14, 2014, previously published on October 9, 2014The staggering statistics on the use of social media should come as a surprise to no one. According to 2014 numbers, 74% of adults with online access use social networking sites. For Internet users between ages 18 and 29, that figure is over 90%. Facebook alone has 1.32 billion active users.
|Voters Will Soon Cast Vote on Proposed Constitutional Amendment to Legalize Medical Marijuana - A Summary of the Amendment|
October 14, 2014, previously published on October 8, 2014Amendment 2 will be on the November 4, 2014 election ballot, which if approved by the Florida voters, legalizes a broader use and possession of medical marijuana than the Compassionate Medical Cannabis Act of 2014 commonly referred to as "Charlotte's Web."