THIS NOTICE DESCRIBES HOW MEDICAL INFORMATION ABOUT YOU MAY BE USED AND DISCLOSED, HOW YOU CAN ACCESS THIS INFORMATION, AND YOUR RIGHTS REGARDING YOUR HEALTH INFORMATION. PLEASE REVIEW IT CAREFULLY.
FCTG Operations LLC, doing business as Florida Clinical Trials Group (“FCTG”) is committed to protecting the privacy and security of health information entrusted to us.
This Notice describes our privacy practices regarding protected health information (“PHI”) where FCTG is subject to the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) and other applicable privacy requirements.
Your Rights
When your information is protected by HIPAA, you have certain rights.
Obtain a Copy of Your Health Information
You may ask to inspect or obtain an electronic or paper copy of health information that we maintain about you, subject to limited exceptions permitted by law.
We generally will provide access within the time required by applicable law.
A reasonable, cost-based fee may apply where permitted.
Ask Us to Correct Your Information
You may ask us to correct health information that you believe is inaccurate or incomplete.
We may deny the request in certain circumstances, but we will explain the reason in writing when required.
Request Confidential Communications
You may ask us to contact you in a particular way or at a particular location.
For example, you may request that we contact you at a specific telephone number or mailing address.
We will accommodate reasonable requests as required by law.
Ask Us to Limit Certain Uses or Disclosures
You may ask us not to use or disclose certain health information for treatment, payment, or health care operations.
We are not always required to agree to the request.
Where applicable law requires us to accept a restriction, we will do so.
Obtain an Accounting of Certain Disclosures
You may request a list of certain disclosures of your health information made during the period permitted by law.
The accounting generally does not include disclosures for treatment, payment, health care operations, or certain disclosures made pursuant to your authorization, except where otherwise required by law.
Obtain a Copy of This Notice
You may request a paper copy of this Notice at any time, even if you previously agreed to receive it electronically.
Choose Someone to Act for You
If you have given someone medical power of attorney, if someone is your legal guardian, or if another person is otherwise legally authorized to act as your personal representative, that person may exercise your rights when appropriate.
We may verify that person's authority before acting on a request.
File a Privacy Complaint
You may file a complaint with FCTG if you believe your privacy rights have been violated.
You may also file a complaint with the U.S. Department of Health and Human Services Office for Civil Rights.
FCTG will not retaliate against you for filing a privacy complaint or exercising your privacy rights.
How We May Use and Disclose Your Health Information
Treatment and Clinical Care
Where applicable, we may use or disclose your health information to physicians, investigators, nurses, pharmacists, laboratories, imaging providers, and other health care professionals involved in your care or clinical research activities.
Health Care Operations
We may use or disclose health information to operate our organization and support activities such as:
- Quality assurance
- Compliance
- Staff training
- Clinical operations
- Safety oversight
- Internal review
- Auditing
- Information technology and security
- Regulatory readiness
Payment
Where applicable, we may use or disclose health information as necessary to obtain payment or reimbursement for health care services or to administer applicable payment-related activities.
Clinical Research
Because FCTG conducts clinical research, health information may be used or disclosed for research in accordance with applicable law.
Depending on the circumstances, this may occur:
- With your written HIPAA authorization
- Pursuant to an authorization contained within approved research documents
- Under an IRB or Privacy Board waiver when legally permitted
- For limited activities preparatory to research where legally permitted
- Through the use of de-identified information
- Through other mechanisms permitted by HIPAA and applicable research regulations
Clinical trial participation is also governed by the applicable informed consent process and study-specific requirements.
Business Associates and Service Providers
We may share health information with organizations that perform functions or services for FCTG when such access is necessary.
Where HIPAA requires it, these organizations are subject to agreements requiring them to appropriately protect PHI.
Public Health and Safety
We may disclose health information for legally authorized public health and safety activities, such as:
- Reporting certain diseases or conditions
- Reporting adverse events
- Product safety or recall activities
- Preventing or reducing a serious threat to health or safety
- Reporting suspected abuse, neglect, or domestic violence when authorized or required by law
Health Oversight
We may disclose health information to authorized health oversight agencies for audits, inspections, investigations, licensing activities, or other activities permitted by law.
Compliance With Law
We may disclose information when federal or state law requires us to do so.
Organ and Tissue Donation
Where applicable, we may disclose information to organizations involved in organ, eye, or tissue donation and transplantation.
Medical Examiners and Funeral Directors
We may disclose health information to coroners, medical examiners, or funeral directors as authorized by law.
Workers' Compensation
We may disclose health information as permitted or required for workers' compensation purposes.
Law Enforcement and Government Functions
We may disclose information for certain legally authorized law-enforcement activities, health oversight activities, judicial proceedings, national security functions, or other government purposes.
Judicial and Administrative Proceedings
We may disclose health information in response to a valid court or administrative order, subpoena, discovery request, or other lawful process when applicable legal requirements have been satisfied.
Substance Use Disorder Records
If FCTG receives or maintains substance use disorder patient records protected by 42 CFR Part 2, additional confidentiality protections apply.
Such records generally may not be used or disclosed, or testimony provided about them, in a civil, criminal, administrative, or legislative investigation or proceeding against the patient unless the patient provides the required consent or the use or disclosure is authorized by an appropriate court order and accompanying legal process as required by law.
Uses Requiring Your Written Authorization
For uses or disclosures not otherwise permitted by this Notice or applicable law, we will obtain your written authorization when required.
This may include certain:
- Marketing activities
- Sales of protected health information
- Uses or disclosures of psychotherapy notes, when applicable
- Research activities requiring individual authorization
- Other uses or disclosures for which authorization is required by law
If you give us written authorization, you may generally revoke it in writing at any time.
Revocation will not affect actions already taken in reliance on a valid authorization and may be subject to research-specific legal requirements.
Our Responsibilities
FCTG is required, when HIPAA applies, to:
- Maintain the privacy and security of your protected health information
- Follow the privacy practices described in the current version of this Notice
- Provide you with a copy of this Notice
- Notify affected individuals following a breach when notification is required by law
- Limit uses and disclosures of PHI as required by applicable law
- Respect the privacy rights available to you under HIPAA and other applicable requirements
We will not use or disclose your health information in a manner inconsistent with this Notice unless you authorize us to do so or applicable law permits or requires the use or disclosure.
Clinical Trial-Specific Requirements
This Notice does not replace:
- A clinical trial informed consent form
- A study-specific HIPAA authorization
- Medical-record release authorization
- Sponsor- or IRB-approved privacy language
- Other research-specific notices or authorizations
When you participate in a clinical trial, the applicable study documents will describe additional ways in which information may be collected, used, retained, and disclosed.
Changes to This Notice
We may change the terms of this Notice and may make the revised Notice applicable to health information we already maintain as well as information received in the future, to the extent permitted by law.
The current Notice will be available:
- On our website
- At applicable FCTG locations
- Upon request
Questions or Complaints
For questions about this Notice, requests involving your privacy rights, or privacy complaints, contact:
Privacy Officer
Florida Clinical Trials Group
8200 W Sunrise Blvd., Suite A-3
Plantation, FL 33322
Phone: 772-297-3057
Email: privacy@floridactg.com
Website: www.floridactg.com
You may also submit a complaint to the:
U.S. Department of Health and Human Services
Office for Civil Rights
Information regarding filing a complaint is available through the HHS Office for Civil Rights.
FCTG will not retaliate against anyone for filing a complaint in good faith.
