Notice of Privacy Practices for Protected Health Information (HIPAA)
This Notice (NPP) Describes How Medical Information About You May Be Used And Disclosed And How You May Get Access To This Information. Please Review It Carefully.
Suncoast Clinical Research (SCR) conducts clinical trials jointly with pharmaceutical companies and their agents, local physicians and other affiliated healthcare professionals and organizations.
Our policies are based on the requirements of the Health Insurance Portability and Accessibility Act of 1996 and updated with the HITECH Omnibus Rule requirements.
The privacy practices described in this notice will be followed by all participating healthcare professionals and employees (physicians, protocol investigators, research coordinators, laboratory, regulatory and support personnel) as well as pharmaceutical company employees and agents.
We are required by law to:
If you have any questions about this notice or would like further information, please contact the SCR Privacy Officer at 727-849-4131.
We Safeguard Information about Your Health and Person:
We collect health information from you and store it in a research record as well as on a computer. Records are stored in a secure area and available only to designated staff and only for designated reasons.
All business associates of our facility (contractors, agents and others who need your health information in order to assist us with carrying out our business operations) are required to execute a written contract with our facility to ensure that they also will protect the privacy of your health information.
Typical Uses and Disclosures of Medical Information:
We may use your health information for your treatment and care.
We may contact you with information about clinical trials – past, present or future.
We may disclose your health information to pharmaceutical companies and their agents, institutional review boards and regulatory agencies in accordance with protocol requirements and consent(s) signed by you.
We will disclose your health information to those agencies and entities for whom legal and administrative requirements demand disclosure, including but not limited to:
- When required by law including judicial and administrative proceedings (court order)
- Public health activities (deaths, abuse and/or neglect, domestic violence, product recalls, problems with products, reactions to medications, disease/infection exposure, disease/injury/disability control/prevention)
- Health oversight activities (audits, investigations, inspections)
- Appropriate law enforcement requests (identify or locate a suspect, fugitive, material witness, or missing person)
- Emergencies or to avert serious threat to health or safety
Additional instances where we may need to disclose your health information include but are not limited to:
- Notification and/or communication with your family based on your directions in your Acknowledgement of Receipt of Notice of Privacy Practices form
- Notification and/or communication to provide appointment and study reminders
We will not use or disclose your health information for any purpose not listed above without your specific written authorization. You may revoke any such authorization, at any time, in writing to us.
Types of disclosures that would require your additional authorization include but are not limited to:
- Fundraising communications
- Marketing purposes or sale of PHI
- Psychotherapy notes
- Other uses and types of disclosures not previously described
In the event that SCR is sold or merged with another organization, your health information will become the property of the new owner.
PATIENT PRIVACY RIGHTS:
Right to Inspect and Copy. You have the right to inspect and copy medical information that may be used to make decisions about your care. Usually, this includes medical records, but does not include psychotherapy notes. Your written request to inspect and copy medical information must be directed to the SCR Privacy Officer. We may deny your request to inspect and copy in certain circumstances, particularly when the information release would impact the integrity of the investigational product blinding process. If your request is denied, you may request, in writing, that the denial be reviewed. The SCR Medical Director will review your request and the denial and render a decision. We will comply with the outcome of the review.
Right to Amend. If you feel that medical information we have about you is incorrect or incomplete, you may ask us to include additional information in your medical record. Your written request for amendment and supportive reason(s) must be directed to the SCR Privacy Officer. We may deny your request if you ask us to amend information that:
- Was not created by us
- Is not part of the medical information kept by our office
- Is accurate and complete
- Is not part of the information which you would be permitted to inspect and copy
Right to an Accounting of Disclosures. You have the right to request a summary of disclosures, excluding:
- Disclosures for treatment
- Disclosures to you or your authorized representative
- Disclosures pursuant to your written authorization
- Disclosures for research operations (e.g., to pharmaceutical companies and their agents, institutional review boards and regulatory agencies)
Your written request for disclosures must be directed to the SCR Privacy Officer. Your request must state a time period, which may not be longer than six years from the date of your request.
Right to Request Restrictions. You have the right to request a restriction or limitation on the medical information we use or disclose about you for treatment or healthcare operations. We are not required to agree to your request. Your written request for restrictions must be directed to the SCR Privacy Officer and must include:
- What information you want to limit
- Whether you want to limit our use or disclosure, or both
- To whom you want the limits to apply, for example, disclosures to your spouse
Right to Request Confidential Communication. You have the right to request that we communicate with you about medical matters in a certain way or at a certain location. Your written request for specific confidential restrictions must be directed to the SCR Privacy Officer and must include specifics as to how or where you wish to be contacted. We will accommodate all reasonable requests.
Right to a Paper Copy of This Notice. You have the right to a paper copy of this notice. Your written request for a paper copy of this notice must be directed to the SCR Privacy Officer.
Right to Breach Notification. You have the right to be notified of any breach of your unsecured healthcare information.
CHANGES TO THIS NOTICE: The current notice will always be posted in our office and will always be available on our website www.SuncoastClinicalResearch.com.
We may revise this notice at any time. The revised notice would be effective for medical information previously provided to us, as well as any information we receive in the future. If the revision(s) constitute a material change to this notice, you will be notified to review the revised notice on our website, and you will be requested to sign the revised notice at your next on-site visit.
Effective Date of Notice: September 2013