Regulations for the provision of medical services of 24-hour obstetric monitoring by electronic means

Date of publication: November 22, 2021

I. Definitions

Subscription
temporary right to receive a Medical Service chosen by the Patient.
Application
the Carebits application for mobile devices, used to remotely perform cardiotocography (CTG) tests and sending their records to the Obstetric Monitoring Center in order to provide Medical Services to the Patient.
Authorization of CTG recording
checking and confirmation by the medical staff of the Carebits Obstetric Monitoring Center (hereinafter referred to as CMP CB) correct interpretation of the CTG record that was analyzed by the computer obstetric supervision system.
Study
cardiotocographic examination (CTG), performed as part of the Medical Service by the Patient alone or with the help of the person conducting the pregnancy, using the Sigmafon CTG System. The test consists in the simultaneous recording of the heart rate fetal rate (FHR) and uterine contractions (TOCO). Fetal heart rate (FHR) recording time and activities uterine contractions (TOCO) is at least 30 minutes.
Pricing
the price list of the Medical Service made available to the Patient before concluding the Agreement or made available on the website https://www.carebits.pl.
Obstetric Monitoring Center (or CMP)
A 24-hour medical unit of the Carebits company, employing experienced, certified medical staff to authorization of CTG records.
Login details
data enabling the Patient to access the Website or Application and for identification purposes when providing the Service medical containing:
  • Login - Patient's e-mail address
  • Password – is generated automatically at the time of registration,
is sent by email. The patient can change the password herself. The password must be at least 8 characters, including uppercase and lowercase letters, and contain at least 1 number and 1 special character.
Helpline
information center dedicated to patients, available at the telephone number +48 22 308 03 00 (call cost according to tables of telecommunications operators' fees) available on working days, from Monday to Friday from 8:00 am until 22:00. The helpline is run by certified midwives. Information is provided by the Hotline as part of Hotline Services.
User Manual
information center dedicated to patients, available at the telephone number +48 22 308 03 00 (call cost according to tables of telecommunications operators' fees) available on working days, from Monday to Friday from 8:00 am until 22:00. The helpline is run by certified midwives. Information is provided by the Hotline as part of Hotline Services.
User Manual
description of the Sigmafon CTG System, the Carebits application, their operation and the procedure to be performed effective research recording. The Quick User Manual in a graphic form is attached to the packaging of the KTG System Sigmaphone, and the full version of the User's Manual is available for download from the website www.carebits.pl.
Interpretation/Analysis
reading of the meaning of the CTG chart, presented in the form of numerical values of individual events during CTG recording.
Account
Patient's individual account on the Website and in the Application, enabling access to the results of Tests and own data personal.
Period of Medical Service
Subscription duration: 2 weeks (including up to 14 test records), 4 weeks (including up to 28 test records), 8 weeks (including up to 56 study records). The patient can extend the period of medical service by purchasing another one subscription. The option to extend the subscription period for patients is available up to 2 days from the end of the previous one period.
Doctor/Midwife
gynecologist or midwife leading the pregnancy with whom Carebits sp. z o.o. has a signed contract for the provision of services as part of the implementation of the Medical Service.
Patient
an adult pregnant woman who concluded the Agreement for the provision of Medical Services, accepted the Regulations and provided your personal data, meeting the following conditions:
  • she is 30 weeks pregnant
  • is singleton pregnant,
  • is under the observation of her gynecologist or midwife.
Terms and Conditions
here regulations.
Service
website at https://www.carebits.pl. run by Carebits sp. z o.o. st. Nowy Świat 57/59, apt. 12; 00-042 Warsaw NIP: 5252832211; Regon: 386763411
Sigmafon CTG system
professional digital, wireless, certified cardiotocograph designed for long-term monitoring fetal heart, uterine contractions and fetal movements together with control core transmission software z using the Application.
Medical Service
24/7 Obstetric Monitoring Service and Hotline Service
Hotline Service
a service consisting in access to the Hotline where advice on perinatal care is provided, and marketing activities using ICT systems and communication systems.
Medical Service
a Fetal well-being monitoring service using the Sigmafon mobile CTG System; delivery of interpreted, CTG recording results described and authorized by CMP CB; providing access to their own research results and your own personal data.
Order
ordering a medical service provided by CMP CB. Orders can only be placed via the website www.carebits.pl.. In justified cases, orders can be placed via the Hotline.

II. Legal basis

The Regulations have been prepared taking into account the following legal acts:

  • Act of 18 July 2002 on the provision of electronic services (Journal of Laws of 2019, item 123) - hereinafter referred to as "u.ś.u.d.e.";
  • Act of 16 July 2004 Telecommunications Law (i.e. Journal of Laws of 2014, item 243, as amended);
  • Act of 15 April 2011 on medical activity (Journal of Laws of 2018, item 2190);
  • Act of November 6, 2008 on patients' rights and the Ombudsman for Patients' Rights (Journal of Laws of 2019, item 1127);
  • Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation ) (Text with EEA relevance);
  • Act of 10 May 2018 on the protection of personal data (Journal of Laws of 2019, item 1781);
  • Act of 23 April 1964. Civil Code (Journal of Laws of 2019, item 1145);
  • Act of 30 May 2014 on consumer rights (Journal of Laws of 2019, item 134) - hereinafter referred to as "u.p.k.";
  • Regulation of the Minister of Health of 16 August 2018 on the organizational standard of perinatal care (Journal of Laws of 2018, item 1756)

III. Statements

  1. The Patient using the Medical Services is aware that:
  • using the Medical Services accepts the content of the Regulations;
  • recording, securing and making available to the Patient content related to the provision of Services Medical is carried out using electronic means of communication;
  • In the event of obtaining credible information that the Patient may require immediate assistance and information about the Patient's whereabouts, CMP CB, implementing obligation to provide assistance, may provide the Patient with assistance by providing the necessary information to emergency and medical services;
  • the CTG record indicates the health condition of the fetus at the time of the examination, it does not replace supervision the person conducting the pregnancy and direct consultation with a doctor or midwife;
  • regardless of the results of the Examination, the patient in case of any doubts, concerns, symptoms, etc., must immediately consult with the supervisor pregnancy;
  • the medical service only supports fetal health monitoring and does not replace examinations control, because they are necessary;
  • some components of the gel used when performing the examination with the Sigmafon CTG System, delivered to the Patient by CMP CB may cause allergic reactions. Before Before performing the Examination, the Patient is obliged to read the full version of the Instructions Service located on the website https://www.carebits.pl.
  • for the consequences of providing incorrect, incomplete, untrue, misleading or in otherwise incorrect data, especially regarding third parties, exclusive the patient is responsible;
  • the patient is responsible for the consequences of using the Medical Services in a manner inconsistent or inconsistent with these regulations;
  • Carebits sp. z o.o. is not responsible for damages caused to third parties, occurring in as a result of using the Medical Services by the Patient in a manner inconsistent with the Regulations or by law;
  • Carebits sp. z o.o. is not responsible for damages resulting from the lack of continuity of delivery services Medical, resulting from the circumstances for which Carebits sp. z o.o. does not bear liability and caused by force majeure,
  • Carebits sp. z o.o. is not responsible for the actions and omissions of third parties, except for persons for which CMP CB is responsible under the law;
  • Carebits sp. z o.o. is not responsible for providing untrue or incomplete information by the Patient information during registration, which may prevent the provision of Medical Services in correct way.
  1. By concluding the Agreement, the Patient declares that on the day on which she chose to start the service Medical service, it meets the requirements indicated in the definition of "Patient" contained in the Regulations.
  2. If the connection to the Hotline or CMP CB is not possible, is difficult or takes too long, and the condition If the Patient's health or well-being deteriorates, the Patient is obliged to immediately seek help from a health care facility.

IV. General provisions

  1. Under the conditions set out in these Regulations, Carebits sp. z o.o. testifies for Patients Medical service by electronic means.
  2. Pursuant to Art. 8 sec. 3 point 2 lit. b) u.ś.u.d.e., it is not allowed for the Patient to provide content of an unlawful nature as part of using the services of Carebits sp. z o.o., Carebits sp. z o.o. is not responsible for illegal content provided by the Patient via Medical services provided or made available by Carebits sp. z o.o.
  3. The use of the Medical Service is intended solely for the Patient and is used for monitoring the health of her fetus.
  4. It is forbidden to transfer the KTG Sigmafon System or login data to third parties, or other data used to use the Medical Service. The above actions can result in the cessation of the provision of the Medical Service by CMP CB.
  5. Regulations The patient can record, obtain and recreate at any time through his printing, saving on a suitable medium or downloading it in PDF format and saving it in computer memory from the website: https://www.carebits.pl.
  6. Carebits sp. z o.o. may develop the Medical Service, i.e. expand and change the functionality medical services, as well as add new services. Development of Medical Services, as well as adding new ones services by Carebits sp. z o.o. to the extent that the Agreement has not yet been concluded, does not require consent of the patient.
  7. Prior familiarization is required in order to start using the Medical Service and acceptance by the Patient of these Regulations, the Price List under the selected one Subscription and Privacy Policy available at https://www.carebits.pl.

V. Technical conditions for using the Medical Service with the telephone

  1. The use of a medical service must meet the following technical requirements necessary to cooperate with the Carebits System:
  • A smartphone or tablet with access to the Internet with the Android or iOS operating system;
  • in the case of using the Medical Service on Android mobile devices, it is required to have a medical application installed on Google Play; with the iOS system, it is required to have an installed medical application available in the App Store;
  • active e-mail address.
  1. The purpose of ensuring the security of the Service and data transfer is communication encrypted.
  2. The patient is solely responsible for non-performance or incorrect performance Services, resulting from problems with the connection or Internet coverage at the place where the services are used by the Patient and other technical problems independent of Carebits sp. z o.o.;

VI. Implementation of the medical service

  1. In order to use the Patient Medical Service on the website https://www.carebits.pl performs self-registration, selects the Subscription, selects the method of delivery, places an Order and pays for the selected period of providing the Medical Service.
  2. The Patient's account is activated by sending the access password to the Application and Website to e-mail address provided by the Patient during registration.
  3. After logging in to the Website, the Patient can verify her data provided during registration, in therefore has the option of correcting and/or supplementing them and changing the password. For this purpose, the patient can You can also contact the Hotline or submit a report to the e-mail address office@carebits.pl.
  4. Orders can be placed 24 hours a day, 7 days a week. Submit an order means the submission by the Patient of an offer to conclude a contract for the provision of the Service medical services under the conditions set out in the given Regulations.
  5. The Agreement is concluded upon acceptance of the Order by Carebits sp. z o.o. Adoption Orders by Carebits sp. z o.o. is confirmed by an e-mail sent to e-mail address e-mail address provided by the Patient during registration.
  6. Carebits sp. z o.o. reserves the right, until the Order is accepted, to refuse to complete the Order, in particular due to the exhaustion of the available CTG Systems Sigmafon or for any other legitimate reason. In this case, Carebits sp. z o.o. will inform Patient about the refusal to execute the Order via e-mail and immediately, but not later than within 14 days, will return the funds paid by the Patient money.
  7. Within a maximum of 48 hours from the date of payment (booking the payment), the patient will receive it by courier Sigmafon CTG system (delivery time may be longer on weekends and holidays). making Orders The Patient may choose a different delivery date for the Sigmafon CTG System. IN in the event of a delay in delivery due to the fault of Carebits sp. z o.o. there is an automatic extension Subscription for the period of culpable delay.
  8. The date of commencement of the provision of the Medical Service is the date of receipt of the Sigmafon CTG System by Patient from the courier.
  9. The Patient, from the moment of confirming the Order by Carebits sp. z o.o., may use Hotline Services. The hotline does not provide health services within the meaning of the Act of 15 April 2011 on medical activity (Journal of Laws of 2011, No. 112, item 654). Contact or attempt to contact The hotline cannot replace or delay a possible medical consultation or, in matters thereof requiring contact with the ambulance service on 112.
  10. The condition for the implementation of the Medical Service is correct, in accordance with the instructions and the film training, the Patient's examination using the Sigmafon CTG System in time not shorter than 30 minutes.
  11. The date of completion of the provision of the Medical Service is the date specified in the selected Subscription, unless the Patient extends the Medical Service Period based on another one Subscription.
  12. 3 days before the expiry of the purchased Medical Service Period in accordance with the selected one By subscribing, the Patient will receive a notification by e-mail and/or telephone about the approaching end of the Medical Service Period and the need to return it equipment. Within 5 days of the end of the Medical Service Period, the Hotline will contact you with the Patient in order to arrange a courier to whom the Patient will be obliged to deliver complete CTG Sigmafon device. If the Patient has chosen personal collection when placing the Order equipment should be returned in the same way. If the device is not returned KTG Sigmafon on time, after 5 working days from the end of the Period provision of medical services, Carebits sp. z o.o. has the right to start charging a fee for further use of equipment in the amount of PLN 40 gross per day. A fee may apply for a maximum period of 2 months. The provision of the Medical Service will cease on the expiry date The period of providing the Medical Service.

VII. How to use the Medical Service

  1. Self-research must be carried out in accordance with the User Manual and the training video available on the website https://www.carebits.pl.
  2. A patient may, as a rule, perform one Examination per day - the details result from selected Subscription. If the Examination is performed incorrectly, the Patient may be asked by CMP CB to perform the Test again. Repeat Fee Examination will not be charged.
  3. If the Patient receives clear medical recommendations from her doctor in charge of pregnancy or from your midwife to perform a CTG examination more than once a day and if The patient will inform CMP CB about these recommendations, no fee for repeating the Examination will be charged.
  4. A valid test must last at least 30 minutes from pressing START.
  5. Throughout the duration of the Examination, the Patient must be in a place that has constant range to the wireless Internet, including e.g. via WiFi. Otherwise The medical service may not be provided properly, which may include, in particular, impossibility to perform the Test. Before performing the Examination, the Patient should familiarize herself with with the User Manual.
  6. Each time after a properly conducted examination, a CTG record in graphical form and computer interpretation is sent to the Patient's e-mail address provided during registration.
  7. Records of computer interpretation of the performed Tests are sent to CMP for Authorization CTG recording by medical personnel. Authorized Interpretation (CTG Record Authorization) is sent to the Patient in the form of a message in the Application and by SMS. notification about when an authorized CTG recording appears in the Application, it is sent in the form of a message system medical application and an SMS along with the data of the midwife making the interpreation.
  8. The CTG recording authorization sent to the Patient may contain messages regarding: quality CTG recording, deviations from the norms and/or anomalies, CTG recording quality, necessity re-examination, possible technical problems or a request to contact hotline.
  9. In the event of any warning, alarm or CMP CB will contact the Patient by phone. CMP medical staff will conduct a conversation with the Patient in order to clarify and/or determine the reasons for the occurrence deviations from the model parameters and may order immediate contact with the emergency services rescue. In a situation where it is impossible to contact the Patient by phone, CMP will attempt to contact the emergency contact person at the number provided by the Patient upon registration (if provided). Consultation with the Monitoring Center Obstetrics does not replace the visit of the person conducting the pregnancy, however, it can bring you closer the correctness of the readings and the cause of the event. In case of a sharp deterioration of the condition health or well-being The patient should immediately contact the number emergency number 112 to call an ambulance or go to the nearest facility medical.
  10. Each authorized interpretation of the Study is available for inspection after logging in Patient in the App.
  11. Each interpreted and authorized Test may be made available by the Patient To the doctor/midwife in the Application, provided when registering the doctor's code. The patient can too provide your doctor or midwife with a CTG record in graphic and computer form interpretation sent to her email address
  12. The average waiting time for an authorized interpretation of the Study record is up to 30 minutes. Time this period may be extended in the event of problems with data transmission due to fault telecommunications operator.
  13. The medical service is provided 24 hours a day, 7 days a week. Carebits sp. z o.o. reserves the right to temporarily suspend the provision of Medical Services during carry out maintenance works, which Carebits sp. z o.o. will inform at least several days in advance; this does not apply to events caused by force majeure.
  14. If the device has been mechanically damaged, e.g. flooded or fallen, it should be repaired contact the Helpline and consult whether a professional review of this is necessary devices. The patient may report damage to the device sent to perform the service medical to the email address: office@carebits.pl.
  15. The Patient's report regarding mechanical damage will be considered immediately after its adoption.

VIII. Payment for Medical Service

  1. The medical service is payable, except for registration for testing purposes. The fee is charged by Carebits sp. z o.o., via PayU or other services, in accordance with the Price List given in PLN made available to the Patient and the selected Subscription. Payment methods are available specified on the website https://www.carebits.pl.
  2. Each Patient who has purchased the "until the end of pregnancy" subscription via the Carebits.pl website can use the service without additional payments until delivery, no matter how much the pregnancy termination period is extended.
  3. In the event of early termination of the Sigmafon Carebits CTG telemedicine service, regardless of the purchased package, no refund is due, resulting from the difference between the time of actual use of the service and the paid subscription.

IX. Right to withdraw from the Agreement

  1. The Patient has the right to withdraw from the Medical Service Agreement within 14 days of its conclusion without giving reasons.
  2. The Patient may withdraw from the Medical Service Agreement by submitting an appropriate declaration of withdrawal from the Agreement by e-mail to the email address office@carebits.pl or by post to the address ul. Nowy Świat 57/59 lok.12, 00-042 Warsaw. A template of the declaration of withdrawal from the Agreement, together with relevant instructions, is attached to these Regulations.
  3. After the Patient has exercised the right to withdraw from the Agreement, Carebits sp. z o.o. immediately will send the Patient a confirmation of receipt of the declaration of withdrawal by e-mail.
  4. Withdrawal from the contract will be considered by Carebits sp. z o.o. within 14 days, and decision and method of settlement Carebits sp. z o.o. will inform the Patient by e-mail.
  5. At the express request of the Patient, the provision of the Medical Service may begin before the expiry date the deadline to withdraw from the Agreement. If the Patient exercises the right to withdraw from the Agreement after submitting a request in accordance with art. 21 sec. 2 u.p.k., is obliged to pay for the services provided until withdrawal from the Agreement. The payment amount is calculated in proportion to the scope fulfilled benefit, ztaking into account the price or remuneration agreed in the Agreement.

X. Complaint

  1. The patient may submit a complaint regarding the provided Medical Service:
  • by phone via the Helpline at the telephone number +48 22 308 03 00 (call cost in accordance with the telecommunication operators' fee tables), on working days, from Monday to Friday from 8:00 am to 10:00 pm;
  • by e-mail at: office@carebits.pl;
  • in writing to Carebits sp. z o.o. st. Nowy Świat 57/59 lok.12, 00-042 Warsaw.
  • The Patient's complaint will be considered within 14 days of receipt of the complaint.
  • The result of the complaint will be communicated to the Patient in the form of an e-mail.
  1. Consideration of the complaint may take place through out-of-court methods of consideration complaints. The list and addresses of entities conducting such proceedings are available, e.g. on website of the Office of Competition and Consumer Protection. The consumer can too use out-of-court methods of dealing with complaints and pursuing claims through submit your complaint via the EU online dispute resolution platform online (ODR), available at: https://ec.europa.eu/consumers/odr/
  2. The patient has the right to pursue claims also in court. Jurisdiction for pursuing claims is determined by the district where Carebits sp. z o.o. is based.

XI. Personal data protection policy

  1. The personal data protection policy is described in the Carebits Privacy Policy on the website https://www.carebits.pl.

XII. Final Provisions

  1. All content is protected by copyright, industrial property law and good intangible protected by intellectual property law. None of this content in particular text, photos, programs, graphics, trademarks, icons, logos, etc. presented on the website may not be reproduced or distributed in any form or by any means without prior permission. The patient undertakes to use this content only within the scope of permitted personal use.
  2. Carebits sp. z o.o. may unilaterally change the Regulations, in particular in the event of a change the existing legal provisions regarding the provision of electronic services or distance transactions or in the event of the introduction of new services or modernization and changes in services already provided.
  3. Patients whose Agreements are in progress will be kept informed of any changes hereto Regulations and obliged by new provisions, unless they terminate the concluded Agreement within 14 days from the moment of sending information about changes to these Regulations.
  4. In matters not covered by the Regulations, the provisions of law apply generally applicable.