Utilizing Electronic Health Record Data in Clinical Investigations

August 30, 2018

  On July 19, 2018, the Food and Drug Administration (FDA) finalized its draft guidance for clinical trial sponsors, investigators, contract research organizations, institutional review boards and others using electronic health record (EHR) data in FDA-regulated clinical investigations. Click Here to read entire Legal Alert. Garfunkel Wild can work with your organization to improve your …

ADA Website Accessibility Lawsuits against FQHCs are on the Rise

July 31, 2018

  In order to avoid litigation, FQHCs should review their websites for compliance with the Americans with Disabilities Act (“ADA”). As many of you heard, a few months ago there were a number of lawsuits brought against Federally Qualified Health Centers (“FQHCs”) or demand letters sent to FQHCs in which persons with visual impairments, or …

New York Enacts Drug Take-Back Law: New Requirements for Pharmaceutical Manufacturers and Certain Pharmacies

July 18, 2018

  New York just took its reliance on the voluntary disposal of unused drugs a step further, enacting legislation that requires: (i) pharmaceutical manufacturers to establish formal drug take-back programs, and (ii) chain pharmacies and mail-order pharmacies to provide for the safe collection of drugs (both prescription and non-prescription) by providing consumers with on-site collection, …

New York Expands Medical Marijuana Program as Alternative to Opioids

July 17, 2018

  The New York State Department of Health issued emergency regulations that took effect on July 12, 2018, to expand the conditions for which medical marijuana may be prescribed. Practitioners registered with the Department of Health may issue certifications for the use of an approved medical marijuana product for patients diagnosed with post-traumatic stress disorder …

New York State Authorizes Advanced Home Health Aides

July 12, 2018

  Amendments to the New York Public Health Law and Education Law authorize a Registered Nurse (RN) to assign advanced tasks to a certified home health aide who has obtained additional training and certification as an “Advanced Home Health Aide” (“AHHA”).  The law took effect on May 28, 2018 and the Department of Health and …