Corporate Compliance Program
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We understand that most of our U.S. customers are "Covered Entities" under the Health Insurance Portability and Accountability Act ("HIPAA") privacy and security regulations. As HIPAA Covered Entities, our customers are legally obligated to maintain the privacy of all patient information that they create or receive. While Spectranetics is not a HIPAA Covered Entity (except for certain portions of our group health plan and a small portion of our Neurovascular subsidiary, which is a hybrid entity), we recognize the impact that HIPAA privacy and security regulations have on our customers. Spectranetics remains committed to interacting with our customers and their patients as responsible professionals who are dedicated to maintaining the privacy of information that we receive on the job, consistent with applicable law and regulations.
To perform our jobs, Spectranetics employees may create, develop or receive information about patients' experiences with our medical devices in a variety of situations, including:
- Providing information or technical support for our products
- Interacting with other members of the health care provider team regarding a particular patient´s diagnosis and treatment
- Receiving questions and suggestions about our products and services from patients, nurses, physicians and other health care providers
- Enrolling patients in clinical trials we sponsor and in our remote monitoring system for certain cardiac rhythm management patients
- Collecting information as required by the FDA and other governmental authorities relating to the quality, safety and efficacy of our devices
- Collecting, analyzing and re-analyzing our data in a continuous effort to improve the design, quality and function of our devices
We have provided training materials on HIPAA to our sales and marketing teams and expect our employees to respect each customer's explicit and implicit instructions regarding incidental exposure to protected health information while visiting that customer's site.
If you have any questions or concerns, please contact us at compliance@spnc.com.
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