Disclaimer. Principle Direct collects, analyzes and stores patient genetic data and maintains strict security practices to protect genetic data against unauthorized access, destruction, use, modification or disclosure. Principle Direct prohibits service providers from using or retaining genetic data for commercial purposes other than specified upon collection. Principle Direct prohibits service providers from associating or combining genetic data with previously received information. Use of genetic data by service providers for unauthorized purposes is prohibited. Unauthorized purposes include retaining, using or disclosing the biological sample, extracted genetic material, genetic data or any information regarding the identity of the consumer for any purpose other than those specified in the initial contract.

Third Party Notice. Genetic or phenotypic data may be shared or disclosed to third parties only for the purposes of collecting, testing, analyzing and resulting samples.

Security. Principle Direct maintains strict procedures to protect patient information and genetic data inlcuding following all HIPAA guidelines.

The US Genetic Information Discrimination Act-GINA of 2008 prohibits discrimination on the basis of genetic information in regard to health insurance and employment. The results of genetic testing are considered Protected Health Information, PHI, as described in the Health Insurance Portability and Accountability Act, HIPPA of 1996 (Public Law 104.191). Federal legislation prohibits unauthorized disclosure of confidential personal information.

Consent. All patients tested at Principle Direct consent to the following upon specimen collection:

• No medical decisons should be made based on results without speaking with my healthcare provider first.

• Results should be discussed with appropriate medical management with my healthcare provider.

• No inducements have been offered to provide a genetic sample. Understanding that it is entirely the patient’s decision to have or not to have genetic testing.

• Understanding that each patient is the owner of their medical history and test results.

• Understanding that patient may retain a copy of testing documents for their records.

• The collection, testing and storage of my genetic data for scientific analysis, including testing personnel accessing my genetic data.

Revocation of Consent. Should any patient want to revoke consent, request destruction biological sample and delete account and genetic data, they must contact Principle Direct at direct@principledx.com or in wirting to 2550 Brodhead Road Bethlehem, PA 18020.

Complaints. Patients may file complaints alleging violation to Principle Direct: 2550 Brodhead Road Bethlehem, PA 18020

(For VA Residents) Patients with a complaint about testing can contact the Virginia Attorney General at (800)552-9963, or Consumer Protection Section, 202 North Ninth Street Richmond, VA 23219

Accessing Genetic Data. To access your genetic data or if you need additional information or details, contact us at direct@principledx.com.