Our Commitment to Privacy

The appropriate collection, use and disclosure of patients’ personal health information is fundamental to our day-to-day operations and to patient care. Protecting the privacy and the confidentiality of patient personal information is important to the physicians, scientists and staff at Somata Genesis, Inc. We strive to provide our patients with excellent medical care and service. Every member of Somata Genesis, Inc. must abide by our commitment to privacy in the handling of personal information. This policy was last modified on the 12th day of October, 2018.

 

Applicability of This Privacy Policy

Our Privacy Policy attests to our commitment to privacy and demonstrates the ways we ensure that patient privacy is protected. Our Privacy Policy applies to the personal health information of all our patients that is in our possession and control.

 

What is Personal Health Information?

Personal health information means identifying information about an individual relating to their physical or mental health (including medical history), the providing of health care to the individual, payments or eligibility for health care, organ and tissue donation and health number.

 

The 10 Principles of Privacy

Our Privacy Policy reflects our compliance with fair information practices, applicable laws and standards of practice; HIPAA and 21CFR Part 11.

1. Accountability: We take our commitment to securing patient privacy very seriously. Each physician and employee associated with the Clinical Trials is responsible for the personal information under his/her control. Our employees are informed about the importance of privacy and receive information periodically to update them about our Privacy Policy and related issues.

2. Identifying Purposes - Why We Collect Information: We ask you for information to establish a relationship and serve your medical needs. We obtain most of our information about you directly from you, or from other health practitioners whom you have seen and authorized to disclose to us. You are entitled to know how we use your information and this is described in the Privacy Statement posted at Somata Genesis, Inc. We will limit the information we collect to what we need for those purposes, and we will use it only for those purposes. We will obtain your consent if we wish to use your information for any other purpose.

 

Privacy Policy

3. Consent: You have the right to determine how your personal health information is used and disclosed. For most health care purposes, your consent is implied as a result of your consent to treatment, however, in all circumstances express consent must be written. Your written Consent will be forwarded to the Clinical Coordinator who will document the request in patient’s medical records and notify appropriate division and their supporting staff. Patients who have withdrawn consent to disclose PHI must sign and date the Consent to Withdrawal Form. It is understood that the consent directive applies only to the PHI which the patient has already provided, and not to PHI which the patient might provide in the future: PHIPA permits certain collections, uses, and disclosures of the PHI, despite the consent directive; healthcare providers may override the consent directive in certain circumstances, such as emergencies; and the consent directive may result in delays in receiving health care, reduced quality of care due to healthcare provider’s lacking complete information about the patient, and healthcare provider’s refusal to offer non-emergency care. Your written Consent to Withdrawal Form will be forwarded to the Clinical coordinator who will document the request in patient’s medical records and notify appropriate division and their supporting staff.

4. Limiting Collection: We collect information by fair and lawful means and collect only that information which may be necessary for purposes related to the provision of your medical care.

5. Limiting Use, Disclosure and Retention: The information we request from you is used for the purposes defined. We will seek your consent before using the information for purposes beyond the scope of the posted Privacy Statement. Under no circumstances do we sell patient lists or other personal information to third parties. There are some types of disclosure of your personal health information that may occur as part of this Clinical Trial fulfilling its routine obligations and/or administration management. This includes consultants and suppliers to the Clinical Trial, on the understanding that they abide by our Privacy Policy, and only to the extent necessary to allow them to provide business services or support to this Clinical Trial. We will retain your information only for the time it is required for the purposes we describe and once your personal information is no longer required, it will be destroyed. However, due to our on-going exposure to potential claims, some information is kept for a longer period. Patients may be required to sign and date a Consent to Disclose PHI Form and pay a fee prior to release of information.

6. Accuracy: We endeavour to ensure that all decisions involving your personal information are based upon accurate and timely information. While we will do our best to base our decisions on accurate information, we rely on you to disclose all material information and to inform us of any relevant changes.

7. Safeguards - Protecting Your Information: We protect your information with appropriate safeguards and security measures. Somata Genesis, Inc. maintains personal information in a combination of paper and electronic files. Recent paper records concerning individuals’ personal information are stored in files kept onsite at our offices. Older records may be stored securely offsite. Access to personal information will be authorized only for the physicians and employees associated with the Clinical Trial, and other agents who require access in the performance of their duties, and to those otherwise authorized by law. We provide information to our health care contractors acting on your behalf, on the understanding that they are also bound by law and ethics to safeguard your privacy. Other organizations and agents must agree to abide by our Privacy Policy and may be asked to sign contracts to that effect. We will give them only the information necessary to perform the services for which they are engaged, and will require that they not store, use or disclose the information for purposes other than to carry out those services. Our computer systems are password-secured and constructed in such a way that only authorized individuals can access secure systems and databases. If you send us an e-mail message that includes personal information, such as your name included in the "address", we will use that information to respond to your inquiry. Please remember that e-mail is not necessarily secure against interception. If your communication is very sensitive, you should not send it electronically unless the e-mail is encrypted or your browser indicates that the access is secure. We encourage all Protected Health Information to be sent to medicalrecords@somatagenesis.com from your registered email address for it to reach your electronic Case Record Form directly.

8. Openness - Keeping You Informed: Somata Genesis has prepared this plain-language Privacy Policy to keep you informed. If you have any additional questions or concerns about privacy, we invite you to contact us by phone and we will address your concerns to the best of our ability.

9. Access and Correction: With limited exceptions, we will give you access to the information we retain about you within a reasonable time, upon presentation of a written request and satisfactory identification. We may charge you a fee for this service and if so, we will give you notice in advance of processing your request. If you find errors of fact in your personal health information, please notify us as soon as possible and we will make the appropriate corrections. We are not required to correct information relating to clinical observations or opinions made in good faith. You have a right to append a short statement of disagreement to your record if we refuse to make a requested change. If we deny your request for access to your personal information, we will advise you in writing of the reason for the refusal and you may then challenge our decision.

10. Challenging Compliance: We encourage you to contact us with any questions or concerns you might have about your privacy or our Privacy Policy. We will investigate and respond to your concerns about any aspect of our handling of your information. You can reach us at:

• Clinical Coordinator, Somata Genesis, Inc. 380 North Broadway, Suite 408, Jericho, NY 11753, USA
• Toll Free 1 844 518 9699