STATEMENT OF DATA CONSENT
Background
In accordance with the General Data Protection Regulation (GDPR), we will always ensure that any personal data we collect and process about you is handled in a lawful, fair, and transparent manner. This includes ensuring that your personal data is:
- Collected for specified, explicit and legitimate purposes.
- Adequate, relevant and limited to what is necessary for the purposes for which it is processed.
- Accurate and kept up to date.
- Kept for no longer than is necessary for the purposes for which it is processed.
- Processed in a manner that ensures its security, including protection against unauthorized or unlawful processing, accidental loss, destruction or damage.
We will only share your personal data with third parties when it is necessary for the provision of your medical treatment, or when we are legally obliged to do so. We will also ensure that any third parties we share your personal data with are also GDPR compliant and have appropriate security measures in place to protect your personal data.
You have the right to request access to your personal data at any time, as well as the right to request that your personal data be corrected or deleted. If you have any concerns about how your personal data is being processed, please do not hesitate to contact us.
Declaration
- I have received a full explanation of the nature of the treatment(s) to be provided to me by my Fertility and Hormone Specialist.
- I understand that my personal information will only be used for the purpose of providing me with medical treatment and for the purpose of monitoring and improving the quality of the service provided by my Fertility and Hormone Specialist.
I understand that my personal information will not be disclosed to third parties without my permission, unless required by law.
- I understand that I have the right to access my personal information held by my Fertility and Hormone Specialist and to request that any inaccuracies be corrected.
I understand that I have the right to request that my personal information be deleted, although this may not be possible if it is needed to provide me with medical treatment or to comply with legal requirements.
I consent to the collection, storage, and use of my personal information as described above.
- I understand that the information that my doctor may hold can include my personal identification data (name, address, telephone numbers, credit card etc.), details of my medical condition(s) and any medication prescribed to me, that is necessary to provide a treatment to me.
- I agree that The Medi-Gyn Coordination Center may record, hold, update and use my information for the purposes of monitoring and improving that service. It may also anonymize this information and use it for research purposes.
- I understand that my personal information will not be provided to other health professionals or organisations without my permission. I also understand that in some circumstance’s other doctors at The Medi-Gyn Coordination Center or administrative personnel may need to access my file.
- I understand I have the right to gain access to and to correct this information. I understand that I am entitled to change my consent at any time, and I will request a new consent form from The Medi-Gyn Coordination Center, if I wish to alter my consent.
- I understand that if I require a chaperone for my consultation, I can speak with the reception team to arrange this.
- I understand that The Medi-Gyn Coordination Center will take all necessary measures to ensure the confidentiality and security of my personal data.
- I consent to The Medi-Gyn Coordination Center recording, storing, processing and sharing my personal data as described above.
- I acknowledge that I have read and fully understand the information provided to me in this consent form and that I am freely giving my consent.
- I understand that if I have any questions or concerns about the use of my personal data, I can contact The Medi-Gyn Coordination Center for further information.
- Please sign below to indicate that you have read and understand this consent form, and that you give your consent to The Medi-Gyn Coordination Center to record, store, process and share your personal data as described above.
INFORMED CONSENT FOR PERSONALISED BIOIDENTICAL HORMONE REPLACEMENT THERAPY
Background
Because of the rapidly changing ideas about the safety and effectiveness of hormone therapy we feel it is important to be sure that you have information about the risks and benefits of hormone therapy before you take the therapy we have discussed.
Bioidentical hormones have the exact same chemical structure with your own hormones. Your BHRT prescription is made in a compounding pharmacy and the dose is adjusted to your needs. As it is not a fixed dose combination, this medication is unlicensed. BHRT is often prescribed to women during perimenopause (the time from first symptoms to up to several years beyond the last period) and menopause (starting one year after the last period) for symptoms of hot flushes, vaginal dryness, loss of libido, depression, irritability or PMS like symptoms, bone loss and osteoporosis or its prevention, and cardiovascular disease. Sometimes, hormone therapy may be recommended for PMS, polycystic ovarian syndrome (PCOS), endometriosis or hormonal acne. This may be recommended in addition to nutritional advice or psychological support.
It is important to understand that hormone therapy, including Bioidentical Hormone Replacement Therapy (BHRT), is not without risks. Some of the possible risks include:
- Blood clots: Hormone therapy can increase the risk of developing blood clots, which can lead to serious health problems such as deep vein thrombosis or stroke.
- Breast cancer: Hormone therapy has been linked to an increased risk of developing breast cancer, although the exact risk is not known.
- Uterine cancer: Women who take estrogen-only hormone therapy for a long period of time may have an increased risk of developing uterine cancer.
- Heart disease: Hormone therapy can increase the risk of heart disease, especially in women who are already at high risk for this condition.
- Stroke: Hormone therapy can increase the risk of stroke, especially in women who are already at high risk for this condition.
- Gallbladder disease: Hormone therapy can increase the risk of developing gallbladder disease.
- Migraines: Hormone therapy can worsen migraines in some women.
It is important to discuss the risks and benefits of hormone therapy with your doctor and to carefully consider your individual health history and risk factors before deciding whether hormone therapy is right for you. If you have any questions or concerns, be sure to discuss them with your doctor.
The FDA has only approved Bioidentical Hormone Replacement Therapy (BIHRT) for the treatment of hot flushes and osteoporosis. The use of BIHRT for other symptoms or conditions is considered “off label” and is subject to the discretion of the physician.
It is important to note that the FDA’s approval process for drugs and medical treatments is based on scientific evidence and clinical trials. When a treatment is used “off label,” it means that there is not enough scientific evidence to support its use for the particular condition. In these cases, the physician must make an informed decision based on their medical expertise and the available evidence.
It is important for patients to understand that “off label” use does not necessarily mean that the treatment is not effective or safe, but it does mean that there is limited scientific evidence to support its use for the specific condition. Patients should discuss the risks and benefits of “off label” use with their physician and make an informed decision based on their individual health and medical history.
Potential Benefits
When hormone levels are brought back to “normal” for your age, there is much evidence that your overall health benefits. The risk of osteoporosis and fractures may decrease. Estrogen therapy is the most effective treatment for hot flushes. There may be other long term beneficial effects of treatment, such as improved sleep, mood and memory.
Bioidentical hormone therapy may contain one or any combination of the following hormones: estrogens (estradiol and estriol), progesterone, testosterone and dehydroepiandrosterone (DHEA). Thyroid hormones (thyroxine and triiodothyronine) may also be prescribed depending on your needs.
Bioidentical hormone therapy is designed to restore hormone levels to a “normal” range for a person’s age. This can have several potential benefits, including:
- Decreased risk of osteoporosis and fractures: Estrogen therapy is known to improve bone density and decrease the risk of osteoporosis and fractures.
- Improved sleep, mood, and memory: Hormone therapy may improve sleep quality, mood, and cognitive function.
- Relief of hot flushes: Estrogen therapy is the most effective treatment for hot flushes associated with menopause.
Bioidentical hormone therapy can contain a variety of hormones, including estrogens (estradiol and estriol), progesterone, testosterone, and dehydroepiandrosterone (DHEA). Thyroid hormones, such as thyroxine and triiodothyronine, may also be prescribed, depending on the patient’s needs.
It is important to note that while hormone therapy can have potential benefits, it is not without risks. Patients should discuss the risks and benefits of hormone therapy with their doctor and make an informed decision based on their individual health and medical history.
Risks
Studies showed that using estrogen alone had decreased risk of breast cancer but an increased risk of endometrial cancer. Subsequent studies added synthetic progesterone to HRT, which protected the lining of the womb against endometrial proliferation. It is now thought that the combination of estrogen and progestins (synthetic progesterone) increases the risk of breast cancer over estrogen alone.
The risk of breast cancer depends on a number of other lifestyle and genetic factors, such as obesity, alcohol and smoking; please discuss this further with your doctor.
There is no sufficient data to fully quantify the risks associated with bioidentical progesterone, rather than synthetic progestins, although preliminary data from cohort studies so far may suggest less risk.
We monitor our patients regularly and our clinic protocols recommend routine pelvic ultrasound as well as a mammogram/ breast ultrasound and how often these tests are recommended depends on your risk factors and your doctor will advise you accordingly.
Hormone therapy, including Bioidentical Hormone Replacement Therapy (BIHRT), can have potential risks, and it is important to consider these before starting treatment.
Studies have shown that using estrogen alone can decrease the risk of breast cancer but increase the risk of endometrial cancer. Adding synthetic progesterone (progestins) to hormone therapy can protect the lining of the uterus, but it has been suggested that the combination of estrogen and progestins may increase the risk of breast cancer compared to estrogen alone.
It is important to keep in mind that the risk of breast cancer depends on several lifestyle and genetic factors, such as obesity, alcohol consumption, and smoking. Patients should discuss these risk factors with their doctor to determine the best course of action.
There is limited data available on the risks associated with bioidentical progesterone compared to synthetic progestins, but preliminary data from cohort studies suggests that bioidentical progesterone may have a lower risk.
The clinic protocols at The Medi-Gyn Coordination Center recommend routine pelvic ultrasound, mammogram or breast ultrasound, and the frequency of these tests depends on a patient’s individual risk factors. Your doctor will advise you on the appropriate frequency of these tests.
Declaration
- I understand that there are benefits of this treatment if successful, and I also understand that my Fertility Specialist cannot be sure that the treatment will fully help me.
- I have discussed the reasons for taking hormones with my Fertility Specialist and understand why he/she is prescribing them, and the risks associated with taking hormones, including but not limited to the possibility of increased risk of breast and/or endometrial cancer, blood clotting stroke or heart attack.
- The risks and potential side effects associated with Bioidentical Hormone Replacement Therapy (BHRT) have been explained to me, and I have had the opportunity to ask any questions concerning this treatment.
- I understand that as my consultation and prescription are tailor-made for me, and unless directed otherwise, the doctor will send this prescription directly to the Specialist Pharmacy, who will compound the medication to the standards required.
- I understand that I am responsible for contacting the relevant provider to order and pay for my medication.
- I acknowledge that I have read and fully understand the information provided to me in this declaration and that I have had the opportunity to ask any questions concerning Bioidentical Hormone Replacement Therapy (BHRT).
- I understand that there is no guarantee that the treatment will be successful and that I have discussed the reasons for taking hormones with my Fertility Specialist.
- I understand the risks associated with taking hormones, including but not limited to an increased risk of breast and/or endometrial cancer, blood clotting, stroke, or heart attack.
- I understand that my consultation and prescription are personalized specifically for me and that the doctor will send my prescription directly to the Specialist Pharmacy, who will compound my medication to the required standards.
- I understand that I am responsible for ordering and paying for my medication and that I can contact the relevant provider for this purpose.
Please sign below to indicate that you have read and understand this declaration, and that you accept the risks and responsibilities associated with Bioidentical Hormone Replacement Therapy (BHRT).
Payment policy:
- Your card details will be securely stored on file upon booking your appointment.
- All appointment payments must be made prior to booking the appointment.
- You will be notified before any payment is taken from your card.
- In the event of a missed appointment, the payment will not be refunded.
- If you have any questions or concerns about the payment process, please contact us before booking your appointment.
Cancellation policy:
- Any cancellation or rescheduling of your appointment must be done within a 48-hour advance notice
- Once you start your Medi-Gyn Programme, no cancellation or refund are available at this point as your Programme/ Protocol has been created and is due to begin or has been already started.
- In the event of a cancellation or rescheduling of your appointment, the payment will be refunded to your card
Declaration:
- “Medi-Gyn Health Planning Consultancies” is the trading name of Medi-Gyn, a company owned by Marketa Hakkinen and Irina Bond (75/25 respectively)
- During your consultation, there may be other healthcare professionals present for training and development purposes. You will be introduced to them at the time of your appointment and can inform your doctor if you do not wish for anyone to be present.
- Formal requests for the retrieval of your personal data to external sources can be made using the form available on the clinic’s website. The Medi-Gyn Coordination Center takes the safety of your personal data seriously.
- Photography and imaging may be used as part of your consultation and may be anonymized for training purposes.
- A copy of your patient information record and consent form will be kept in your electronic patient file at The Medi-Gyn Center.
- With your written consent, personal information may be shared with external companies
Relates only to Natural Supplements and Natural Treatment
This statement acknowledges that Medi-Gyn is not a licensed healthcare provider and does not provide medical advice or direct patient care. The responsibility for the medical treatment and care of patients remains with their treating physician.
It is important for patients to understand that Medi-Gyn is not a substitute for professional medical advice, diagnosis, or treatment, and should not be relied on as such. Patients should always consult with their physician regarding any health concerns or questions they may have.
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