TOPSTONE Research follows the Personal Health Information Protection Act with respect to the collection, use and disclosure of personal health information. TOPSTONE Research is committed to ensuring that the personal health information of any patients is treated with respect and sensitivity.
TOPSTONE Research is responsible for personal health information in its possession, including patient information collected, used or received as a result of a patient’s participation in a clinical trial. TOPSTONE Research will ensure that any disclosure of personal health information to a third party or receipt of such information is contractually protected wherever commercially reasonable.
Collection, Use and Disclosure of Personal Health Information
Prior to the collection of personal health information or at the time of collection TOPSTONE Research will state the purpose for which the personal health information is being collected. The collection of personal health information will be limited to that which is necessary for the purposes identified by TOPSTONE Research. Such purposes include: delivery of patient care, research, teaching, administration of health care and meeting legal and regulatory requirements as further described in the Personal Health Information Protection Act. Should the purpose for which the personal health information was originally collected change, the new purpose will be conveyed and the individual patient must consent to the use of such information. Patients participating in clinical trials as subjects will be asked to sign consent forms outlining such use of personal health information.
In certain circumstances and in accordance with the Personal Health Information Protection Act, personal health information can be collected, used or disclosed without the knowledge and consent of the individual. Such circumstances may make it impossible or impractical to seek consent such as legal, medical or security reasons. Further information on these circumstances can be found in the Personal Health Information Protection Act.
Security of Personal Health Information
TOPSTONE Research takes the necessary security measures to ensure the protection of personal health information against loss, theft, unauthorized access, modification or disclosure. In accordance with the Personal Health Information Protection Act, TOPSTONE Research will inform patients/subjects of the loss, theft or inappropriate disclosure of their personal health information as soon as reasonably possible.
Access to Individual Personal Health Information
Upon written request to TOPSTONE Research, an individual will be provided access to his or her personal health information, unless TOPSTONE Research is prevented from doing so by law. TOPSTONE Research will respond to an individual’s written request in compliance with the Personal Health Information Protection Act and at a reasonable cost to the individual.
The Personal Health Information Protection Act can be found at:
http://www.e-laws.gov.on.ca/html/statutes/english/elaws_statutes_04p03_e.htm
HIPAA
http://www.cdc.gov/mmwr/preview/mmwrhtml/m2e411a1.htm
FDA
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm