As of September 1, 2012, Intel-GE Care Innovations LLC (“Care Innovations”) declares that, to the best of our knowledge as of this date, we are in compliance with California Health and Safety Code, Division 104, Part 15, Chapter 8, Sections 119400‐119402 (the “Statute”), based on our good faith understanding of the requirements of the Statute as they apply to medical device manufacturers. We have developed a compliance program tailored to the size, organizational structure, nature of our business, and resources of the company, in compliance with the Statute. Care Innovations’ compliance program is designed in accordance with the most recent version of the AdvaMed Code of Ethics on Interactions with Health Care Professionals (“AdvaMed Code”), a voluntary ethical code established by the medical device and technology industry. The AdvaMed Code is substantively equivalent to the Pharmaceutical Research and Manufacturers of America Code on Interactions with Healthcare Professionals (“PhRMA Code”), but reflects the unique interactions between medical device companies and health care professionals. In addition, Care Innovations’ compliance program is designed in accordance with the United States Department of Health and Human Services, Office of Inspector General’s “compliance program Guidance for Pharmaceutical Manufacturers,” to the extent the guidelines apply to the medical device industry.
California Health and Safety Code, Division 104, Part 15, Chapter 8, Sections 119400‐119402 was signed into law in September 2004 and became effective on July 1, 2005. It mandates compliance with existing voluntary guidance on marketing of prescription drugs by “pharmaceutical companies.” Although the Statute’s legislative history appears to indicate that it was not intended to apply to medical device manufacturers, Care Innovations has posted documents in accordance with the requirements imposed by the Statute on “pharmaceutical companies,” since it is possible California may interpret the Statute to apply to medical device manufacturers as well.