INFORMED CONSENT FOR TESTOSTERONE THERAPY

Please correct the errors described below.

For Female to Male Transition

Fenway Community Health – Transgender Health Program

This form refers to the use of testosterone by persons who wish to become more masculinized as part of a gender transitioning process.

Your initials of the various statements on this form indicate that the risks as well as the changes which may occur as a result of the use of testosterone have been explained to you and that you understand them. If you have questions or concerns about this information, you are encouraged to take the time you need to ask for clarification, read, research, talk with staff, and think about the potential effects of this treatment before signing.

IF YOU DO NOT UNDERSTAND THIS INFORMATION STOP AND ASK FOR CLARIFICATION

Please initial and date each section below to indicate that you understand and agree with the statements.

1. I have been informed that the masculinizing effects of testosterone therapy may take several months to become noticeable and more than five (5) years to be complete. Some of these changes will be permanent including:

  • Hair loss, especially at my temples and crown of my head, possibly male pattern baldness
  • Facial hair growth (i.e., beard, mustache)
  • Deepening of my voice
  • Increased body hair growth (i.e., on arms, legs, chest, back, buttocks, and abdomen, etc.)
  • Enlargement of my clitoris

These additional changes will not be permanent if I stop testosterone therapy:

  • Redistribution of fat to a male pattern (i.e., abdominal fat may increase while fat in the breasts, buttocks, and thighs may decrease)
  • Increased muscle development
  • Increased red blood cells
  • Increased sex drive and energy levels. Possibly increased feelings of aggression or anger
  • Acne, which may become severe and may require treatment
  • Cessation of menstrual cycles (periods) and suspended ovulation (maturing of ova) including changes to/thinning of your vaginal tissue/lining leading to increased potential for easy damage, dryness, or yeast infections

2. I understand that is it not known exactly what the effects of testosterone are on fertility. I have been informed that if I stop taking testosterone, I may not be able to become pregnant in the future. I have been advised to undergo gamete (egg) banking if this is a concern of mine.

3. I understand that brain structures are affected by testosterone and estrogen. The long term effects of changing the levels of one’s natal estrogen through the use of testosterone therapy have not been scientifically studied and are impossible to predict. These effects may be beneficial, damaging, or both.

4. I understand that everyone’s body is different and that there is no way to predict what my response to hormones will be. I also understand that the right dosage for me may not be the same as for someone else. I further understand that I must follow my prescribed regimen of testosterone treatment to continue to receive hormone therapy at this clinic.

5. I will have complete physical examinations and lab tests periodically as required to make sure I am not having an adverse reaction to testosterone and to continue good health care. I understand that this is required to continue testosterone therapy at this health center.

6. I have been informed that using testosterone may increase my risk of developing diabetes in the future because of changes in my ovaries.

7. I understand that the endometrium (lining of the uterus) is able to turn testosterone into estrogen and may increase the risk of cancer of the endometrium. Not having periods may increase this risk. Continued pelvic exams and cervical cancer screenings are strongly recommended unless there has been a removal of the ovaries, uterus, and cervix.

8. I understand that testosterone therapy should not be relied upon to prevent pregnancy. Even with the cessation of periods, use of a barrier method of birth control is advised during sex where semen could enter the vagina or uterus.

9. I understand the effects of testosterone therapy by itself will not provide protection from sexually transmitted diseases or HIV. Use of barriers and safer sexual practices are recommended to reduce chances of infections.

10. The effects of testosterone therapy do not provide protection from cervical or breast cancer. Annual breast exams, monthly self-exams, and annual mammograms/cancer screenings after the age of 40 are highly recommended even after chest reconstruction.

11. I understand fatty tissue in the breasts and body is able to turn excess testosterone into estrogen, which may increase my risk of breast cancer and decrease or impede the desired effects of testosterone therapy.

12. I have been informed that testosterone may lead to liver inflammation and damage. I have been informed that I will be monitored for liver problems before starting testosterone therapy and periodically during therapy.

13. I have been informed that if I take testosterone my good cholesterol (HDL) will probably go down and bad cholesterol (LDL) will go up. This may increase my risk of heart attack or stroke in the future. The rates for FTMs on testosterone are similar to that of natal males.

14. I understand that testosterone therapy may cause changes in my emotions and moods and that my providers can assist me to find support services and other resources to explore and cope with these changes.

15. I agree that if I have any adverse reactions or side effects to testosterone I will inform my health care provider.

16. I agree to tell my provider about any non-clinic hormones, dietary supplements, herbs, recreational drugs, or medications I might be taking. Sharing this information will help my provider to prevent potentially harmful interactions. I have been informed that staff will continue to provide me with medical care, regardless of what information I share with them.

17. I agree to take testosterone as prescribed and to inform my provider of any problems or dissatisfaction I may have with my treatment. I understand that if I take too much testosterone my body may convert it to estrogen.

18. I understand that there are medical conditions that could make taking testosterone either dangerous or physically damaging. I agree that if clinic staff suspect I may have any condition that could be dangerous to me, I will be evaluated for it before the decision to start or continue testosterone therapy is made. I understand that if I do not agree to be evaluated, my prescription for testosterone may be cancelled or refused.

19. I understand that I can choose to stop taking testosterone at any time. I also understand that my provider can discontinue treatment for clinical reasons. I agree to follow a prescribed reduction plan if either of these situations occurs to reduce negative and potentially harmful side effects that may occur if I suddenly stop taking testosterone.

All the information above has been explained to my satisfaction AND (check only one)

DISCLAIMER: By typing your name below, you are signing this application electronically. You agree that your electronic signature is the legal equivalent of your manual signature on this application.

HIPAA NOTICE OF PRIVACY PRACTICES

THIS NOTICE DESCRIBES HOW MEDICAL INFORMATION ABOUT YOU MAY BE USED AND DISCLOSED AND HOW YOU CAN OBTAIN ACCESS TO THIS INFORMATION. PLEASE REVIEW IT CAREFULLY.

The terms of this Notice of Privacy Practices ("Notice") apply to Restoremd, its affiliates, and its employees. Restoremd will share protected health information of patients as necessary to carry out treatment, payment, and health care operations as permitted by law.

We are required by law to maintain the privacy of our patients' protected health information and to provide patients with notice of our legal duties and privacy practices with respect to protected health information.We are required to abide by the terms of this Notice for as long as it remains in effect. We reserve the right to change the terms of this Notice as necessary and to make a new notice of privacy practices effective for all protected health information maintained by Restoremd We are required to notify you in the event of a breach of your unsecured protected health information.We are also required to inform you that there may be a provision of state law that relates to the privacy of your health information that may be more stringent than a standard or requirement under the Federal Health Insurance Portability and Accountability Act ("HIPAA''). A copy of any revised Notice of Privacy Practices or information pertaining to a specific State law may be obtained by mailing a request to the Privacy Officer at the address shown at the bottom of this notice.

USES AND DISCLOSURES OF YOUR PROTECTED HEALTH INFORMATION:

Authorization and Consent: Except as outlined below, we will not use or disclose your protected health information for any purpose other than treatment, payment or health care operations unless you have signed a form authorizing such use or disclosure. You have the right to revoke such authorization in writing, with such revocation being effective once we actually receive the writing; however, such revocation shall not be effective to the extent that we have taken any action in reliance on the authorization, or if the authorization was obtained as a condition of obtaining insurance coverage, other law provides the insurer with the right to contest a claim under the policy or the policy itself.

Uses and Disclosures for Treatment: We will make uses and disclosures of your protected health information as necessary for your treatment. Doctors and nurses and other professionals involved in your care will use information in your medical record and information that you provide about your symptoms and reactions to your course of treatment that may include procedures, medications, tests, medical history, etc.

Uses and Disclosures for Payment: We will make uses and disclosures of your protected health information as necessary for payment purposes. During the normal course of business operations, we may forward information regarding your medical procedures and treatment to your insurance company to arrange payment for the services provided to you. We may also use your information to prepare a bill to send to you or to the person responsible for your payment.

Uses and Disclosures for Health Care Operations: We will make uses and disclosures of your protected health information as necessary, and as permitted by law, for our health care operations, which may include clinical improvement, professional peer review, business management, accreditation and licensing, etc. For instance, we may use and disclose your protected health information for purposes of improving clinical treatment and patient care.

Individuals Involved In Your Care: We may from time to time disclose your protected health information to designated family, friends and others who are involved in your care or in payment of your care in order to facilitate that person's involvement in caring for you or paying for your care. If you are unavailable, incapacitated, or facing an emergency medical situation and we determine that a limited disclosure may be in your best interest, we may share limited protected health information with such individuals without your approval. We may also disclose limited protected health information to a public or private entity that is authorized to assist in disaster relief efforts in order for that entity to locate a family member or other persons that may be involved in some aspect of caring for you.

Business Associates: Certain aspects and components of our services are performed through contracts with outside persons or organizations, such as auditing, accreditation, outcomes data collection, legal services, etc. At times it may be necessary for us to provide your protected health information to one or more of these outside persons or organizations who assist us with our health care operations. In all cases, we require these associates to appropriately safeguard the privacy of your information.

Appointments and Services: We may contact you to provide appointment updates or information about your treatment or other health-related benefits and services that may be of interest to you. You have the right to request and we will accommodate reasonable requests by you to receive communications regarding your protected health information from us by alternative means or at alternative locations. For instance, if you wish appointment reminders to not be left on voice mail or sent to a particular address, we will accommodate reasonable requests. With such request, you must provide an appropriate alternative address or method of contact. You also have the right to request that we not send you any future marketing materials and we will use our best efforts to honor such request. You must make such requests in writing, including your name and address, and send such writing to the Privacy Officer at the address below.

Other Uses and Disclosures: We are permitted and/or required by law to make certain other uses and disclosures of your protected health information without your consent or authorization for the following:

  • Any purpose required by law.
  • Public health activities such as required reporting of immunizations, disease, injury, birth, and death, or in connection with public health investigations.
  • If we suspect child abuse or neglect; if we believe you to be a victim of abuse, neglect, or domestic violence.
  • To the Food and Drug Administration to report adverse events, product defects, or to participate in product recalls.
  • To your employer when we have provided health care to you at the request of your employer.
  • To a government oversight agency conducting audits, investigations, civil or criminal proceedings.
  • Court or administrative ordered subpoena or discovery request.
  • To law enforcement officials as required by law if we believe you have been the victim of abuse, neglect, or domestic violence. We will only make this disclosure if you agree or when required or authorized by law.
  • To coroners and/or funeral directors consistent with law.
  • If necessary, to arrange an organ or tissue donation from you or a transplant for you.
  • If you are a member of the military, we may also release your protected health information for national security or intelligence activities; and
  • To workers' compensation agencies for workers' compensation benefit determination.

DISCLOSURES REQUIRING AUTHORIZATION:

Marketing: We must obtain your authorization for any use or disclosure of your protected health information for marketing, except if the communication is in the form of (1) a face-to-face communication with you, or (2) a promotional gift of nominal value. Sale of Protected Information: We must obtain your authorization prior to receiving direct or indirect remuneration in exchange for your health information; however, such authorization is not required where the purpose of the exchange is for:

  • Public health activities.
  • Research purposes if we receive only a reasonable, cost-based fee to cover the cost to prepare and transmit the information for research purposes. Updated by AK 12/2020
  • Treatment and payment purposes.
  • Health care operations involving the sale, transfer, merger or consolidation of all or part of our business and for related due diligence.
  • Payment we provide to a business associate for activities involving the exchange of protected health information that the business associate undertakes on our behalf (or the subcontractor undertakes on behalf of a business associate) and the only remuneration provided is for the performance of such activities;
  • Providing you with a copy of your health information or an accounting of disclosures.
  • Disclosures required by law.
  • Disclosures of your health information for any other purpose permitted by and in accordance with the Privacy Rule of HIPAA, as long as the only remuneration we receive is a reasonable, cost-based fee to cover the cost to prepare and transmit your health information for such purpose or is a fee otherwise expressly permitted by other law; or
  • Any other exceptions allowed by the Department of Health and Human Services.

RIGHTS THAT YOU HAVE REGARDING YOUR PROTECTED HEALTH INFORMATION:

Access to Your Protected Health Information: You have the right to copy and/or inspect much of the protected health information that we retain on your behalf. For protected health information that we maintain in any electronic designated record set, you may request a copy of such health information in a reasonable electronic format, if readily producible.Requests for access must be made in writing and signed by you or your legal representative.You may obtain a "Patient Access to Health Information Form" by calling the Privacy Officer at (513)-228-0077. You will be charged a reasonable copying fee and actual postage and supply costs for your protected health information. If you request additional copies you will be charged a fee for copying and postage.

Amendments to Your Protected Health Information: You have the right to request in writing that protected health information that we maintain about you be amended or corrected.We are not obligated to make requested amendments, but we will give each request careful consideration.All amendment requests, must be in writing, signed by you or legal representative, and must state the reasons for the amendment/correction request. If an amendment or correction request is made,we may notify others who work with us if we believe that such notification is necessary. You may obtain an "Amendment Request Form" by calling the Privacy Officer at (513)-228-0077.

Accounting for Disclosures of Your Protected Health Information: You have the right to receive an accounting of certain disclosures made by us of your protected health information. Requests must be made in writing and signed by you or your legal representative. "Accounting Request Forms" are available from the front office person or individual responsible for medical records. The first accounting in any 12-month period is free; you will be charged a fee for each subsequent accounting you request within the same 12-month period.You will be notified of the fee at the time of your request.

Restrictions on Use and Disclosure of Your Protected Health Information: You have the right to request restrictions on uses and disclosures of your protected health information for treatment, payment, or health care operations. We are not required to agree to most restriction requests but will attempt to accommodate reasonable requests when appropriate. You do, however, have the right to restrict disclosure of your protected health information to a health plan if the disclosure is for the purpose of carrying out payment or health care operations and is not otherwise required by law, and the protected health information pertains solely to a health care item or service for which you, or someone other than the health plan on your behalf, has paid [Practice Name] in full. If we agree to any discretionary restrictions, we reserve the right to remove such restrictions as we appropriate. We will notify you if we remove a restriction imposed in accordance with this paragraph. You also have the right to withdraw, in writing or orally, any restriction by communicating your desire to do so to the individual responsible for medical records.

Right to Notice of Breach: We take very seriously the confidentiality of our patients’ information, and we are required by law to protect the privacy and security of your protected health information through appropriate safeguards. We will notify you in the event a breach occurs involving or potentially involving your unsecured health information and inform you of what steps you may need to take to protect yourself.

Paper Copy of this Notice: You have a right, even if you have agreed to receive notices electronically, to obtain a paper copy of this Notice. To do so, please submit a request to the Privacy Officer at the address shown at the bottom of this notice.

Complaints: If you believe your privacy rights have been violated, you can file a complaint in writing.To file a complaint with Restoremd Please contact 513-228-0077.You may also file a complaint with the Secretary of the U.S.Department of Health and Human Services at the US Department of Health and Human Services Office for Civil Rights by sending a letter to 200Independence Avenue, Washington, D.C. 20201, calling 1-877-696- 6775 or visiting www.hhs.gov/ ocr/privacy/hipaa/complaints/. There will be no retaliation for filing a complaint.

For Further Information: If you have questions, need further assistance regarding or would like to submit a request pursuant to this Notice, you may contact the 1513, LLC Privacy Officer by phone at 513-228-0077 or at the following address: 15 Cincinnati Ave, Sute 5, Lebanon Ohio 45036.

HIPAA-ACKNOWLEDGEMENT OF RECEIPT

Notice of Privacy Practices

We at RestoreMD are required by law to maintain the privacy of and provide individuals with the attached Notice of our legal duties and privacy practices with respect to protected health information. If you have any objections to the Notice, please ask to speak with our HIPAA Compliance Officer in person or by phone at our main phone number. If you would like a copy of the Notice, please ask.

I hereby acknowledge that I have reviewed the HIPAA Notice of Privacy Practice document.

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