Disclosure to Medical/Dental Device Companies

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We are often asked whether a patient authorization is required in order to disclose protected health information (PHI) to a medical or dental device company. Similarly, practices have asked whether device companies will be considered business associates of the practice. The answer to both questions lies in whether or not the device company is considered a healthcare provider, as defined by the Privacy Rule.

A healthcare provider is defined as an entity that furnishes, bills or is paid for healthcare in the normal course of business.

If the device company provides healthcare (care, services or supplies related to the health of an individual), the company will be considered a healthcare provider (and must comply with HIPAA requirements as a covered entity). A patient authorization is not required in order to disclose PHI to other healthcare providers that are involved in the treatment of a patient. Nor is a business associate agreement required with such entities.

For more detailed information, please see the article “Medical & Dental Device Companies” in the December 2015 Advisor.

Hazard Communication Workplace Labeling

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When the Hazard Communication Standard was updated in 2012, the burden of providing chemical hazard labeling was shifted from employers to the manufacturers and distributors of hazardous chemical products. Previously, employers had to supplement manufacturer labels to indicate hazard warnings for health, fire, reactivity and special hazards, along with a notation of the name of the product and an indication of the target organs. After December 1, 2015, manufacturers will have to ship products with a compliant label that includes pictograms, hazard statements, etc.

For the rare circumstances in which the manufacturer label is not on a container, the employer will have to provide workplace labeling. A common example of this situation is when an employer orders a large bottle of a product (such as isopropyl alcohol), and then pours it into smaller containers/pumps/dispensers for use throughout the workplace.

The standard defines workplace labeling as:

Product identifier and words, pictures, symbols, or combination thereof, which provide at least general information regarding the hazards of the chemicals, and which, in conjunction with the other information immediately available to employees under the hazard communication program, will provide employees with the specific information regarding the physical and health hazards of the hazardous chemical.

For more information on how to accomplish workplace labeling when it is required, refer to the article in the December 2015 issue of the American Practice Advisor.