As applicable:
Cardiopulmonary Products
Services may include or relate to on-site and/or remote product: maintenance, repairs, technical support, education, training, installation, operation, performance and data management.
Neuromodulation Products
Services may include or relate to on-site and/or remote: product maintenance, technical support, education, training, use, operation, battery-life calculation, performance and data management; patient support services; logistical support; and cloud-based patient data solutions.
For both Cardiopulmonary and Neuromodulation Products, the “Services” do not include the following: (a) any Treatment or Payment activities of Business Associate involving the use and/or disclosure of PHI pursuant to 45 C.F.R. § 164.506(c), to the extent Business Associate acts in the capacity of a Health Care Provider; (b) any uses or disclosures by Business Associate of PHI received in its capacity as a medical device manufacturer subject to the jurisdiction of the FDA with respect to its FDA-approved VNS therapy devices and/or related products pursuant to 5 C.F.R. § 164.512(b)(iii); or (c) any uses or disclosures by Business Associate of PHI received pursuant to a HIPAA authorization under 45 C.F.R. § 164.508.
Cardiopulmonary Products
Services may include or relate to on-site and/or remote product: maintenance, repairs, technical support, education, training, installation, operation, performance and data management.
Neuromodulation Products
Services may include or relate to on-site and/or remote: product maintenance, technical support, education, training, use, operation, battery-life calculation, performance and data management; patient support services; logistical support; and cloud-based patient data solutions.
For both Cardiopulmonary and Neuromodulation Products, the “Services” do not include the following: (a) any Treatment or Payment activities of Business Associate involving the use and/or disclosure of PHI pursuant to 45 C.F.R. § 164.506(c), to the extent Business Associate acts in the capacity of a Health Care Provider; (b) any uses or disclosures by Business Associate of PHI received in its capacity as a medical device manufacturer subject to the jurisdiction of the FDA with respect to its FDA-approved VNS therapy devices and/or related products pursuant to 5 C.F.R. § 164.512(b)(iii); or (c) any uses or disclosures by Business Associate of PHI received pursuant to a HIPAA authorization under 45 C.F.R. § 164.508.