Dokumendiregister | Terviseamet |
Viit | 11.1-12/24/8577-4 |
Registreeritud | 11.09.2024 |
Sünkroonitud | 12.09.2024 |
Liik | Väljaminev dokument |
Funktsioon | 11.1 Turustamise järgne järelevalve (post-marketing surveillance) |
Sari | 11.1-12 Turujärelevalvega seotud muu kirjavahetus („tahetakse infot“) - Nõustamine |
Toimik | 11.1-12/2024 |
Juurdepääsupiirang | Avalik |
Juurdepääsupiirang | |
Adressaat | Horusmed OÜ |
Saabumis/saatmisviis | Horusmed OÜ |
Vastutaja | Piret Põiklik (TA, Peadirektori asetäitja (1) vastutusvaldkond, Meditsiiniseadmete osakond) |
Originaal | Ava uues aknas |
From: "Meditsiiniseadmed (Medical Devices)" <[email protected]>
Sent: Wed, 11 Sep 2024 09:03:21 +0000
To: "Meditsiiniseadmed (Medical Devices)" <[email protected]>; "Boris Fahrnberger" <[email protected]>
Subject: Vs: Meeting in EE
Dear Boris,
I apologize for the small delay in my follow-up e-mail. But instead of the contact e-mail of my colleague, I am able to provide you with the points that they find most relevant in planning anything to do with providing health care services in Estonia:
Our Health Services Organisation Act states:
1. Health services are the activities of health care professionals for the prevention, diagnosis or treatment of diseases, injuries or intoxication in order to reduce the malaise of persons, prevent the deterioration of their state of health or development of the diseases, and restore their health.
2. Health care professionals are doctors, dentists, nurses and midwives if they are registered with the Health Board.
3. A health care professional may provide health services within the acquired profession or speciality with regard to which the Health Board has issued a certificate of registration of the person as a health care professional.
Also, there is an activity licence required for the provision of health care services.
An activity licence is required for operation in the following areas of activity:
1) the provision of general medical care on the basis of a practice list of a family physician;
2) the provision of emergency medical care;
3) the provision of specialised medical care;
3) the independent provision of nursing;
4) the independent provision of midwifery care.
An activity licence grants the right to provide health services in the place of business specified in the activity licence.
So in short: in order to have the right to treat illnesses, one has to a) be a registered specialist doctor and b) have an activity licence for the provision of health services.
A legal body (registered in Estonia) must have the rooms and equipment and personnel to get that activity license.
More information: https://www.eesti.ee/eraisik/en/artikkel/licences-and-notices-of-economic-activity/healthcare/activity-licence-for-the-provision-of-health-services
Regarding the registration of health care professionals: https://www.terviseamet.ee/en/healthcare/registration-of-health-care-professionals
I hope this is helpful for you to start orienting in the requirements applicable in Estonia.
Best regards
Piret Põiklik
Head of Department
Department of Medical Devices
Phone +372 5853 3610
[email protected] | [email protected]
Terviseamet | Health Board +372 794 3500 [email protected] Paldiski mnt 81, 10614 Tallinn |
This e-mail and any attachments may contain sensitive and privileged information. If you are not the intended recipient, please notify the sender immediately by return e-mail, delete this e-mail and destroy any copies. Any dissemination or use of this information by a person other than the intended recipient is unauthorized and may be illegal.
Saatja: Meditsiiniseadmed (Medical Devices) <[email protected]>
Saatmisaeg: teisipäev, 27. august 2024 08:07
Adressaat: Boris Fahrnberger <[email protected]>; Meditsiiniseadmed (Medical Devices) <[email protected]>
Teema: Vs: Meeting in EE
Hello,
3pm is good for me.
We don’t usually use Google Meet, but hopefully there will be no technical issues and if not so, we will resolve them.
Best regards
Piret Põiklik
Head of Department
Department of Medical Devices
Phone +372 5853 3610
[email protected] | [email protected]
Terviseamet | Health Board +372 794 3500 [email protected] Paldiski mnt 81, 10614 Tallinn |
This e-mail and any attachments may contain sensitive and privileged information. If you are not the intended recipient, please notify the sender immediately by return e-mail, delete this e-mail and destroy any copies. Any dissemination or use of this information by a person other than the intended recipient is unauthorized and may be illegal.
Saatja: Boris Fahrnberger <[email protected]>
Saatmisaeg: esmaspäev, 26. august 2024 16:57
Adressaat: Meditsiiniseadmed (Medical Devices) <[email protected]>
Teema: Re: Meeting in EE
Tähelepanu! Tegemist on väljastpoolt asutust saabunud kirjaga. Tundmatu saatja korral palume linke ja faile mitte avada. |
Hello,
thanks for coming back.
Yes, if we have no chance to check it before our TLL travel, Friday would suit well if afternoon. What do you think about 3pm Estonian time?
Shall I send you a link to Google Meet?
Thanks a lot and best regards,
Boris Fahrnberger
Am Mo., 26. Aug. 2024 um 13:40 Uhr schrieb Meditsiiniseadmed (Medical Devices) <[email protected]>:
Dear Boris J. Fahrnberger
Thank you for contacting us.
As our department is located in Tartu, it might be faster and easier to meet online. On the 6th of September you can name a time that would be suitable to you. Perhaps planning for around 30 minutes to start with?
Best regards
Piret Põiklik
Head of Department
Department of Medical Devices
Phone +372 5853 3610
[email protected] | [email protected]
Terviseamet | Health Board
+372 794 3500
[email protected]
www.terviseamet.eePaldiski mnt 81, 10614 Tallinn
This e-mail and any attachments may contain sensitive and privileged information. If you are not the intended recipient, please notify the sender immediately by return e-mail, delete this e-mail and destroy any copies. Any dissemination or use of this information by a person other than the intended recipient is unauthorized and may be illegal.
Saatja: Boris Fahrnberger <[email protected]>
Saatmisaeg: esmaspäev, 26. august 2024 14:12
Adressaat: Meditsiiniseadmed (Medical Devices) <[email protected]>
Teema: Meeting in EE
Tähelepanu! Tegemist on väljastpoolt asutust saabunud kirjaga. Tundmatu saatja korral palume linke ja faile mitte avada.
Dear Ms Piret Põiklik,
I hope this e-Mail finds you well.
We are the founders of a telehealth startup in Tallinn, integrating medical devices for efficient remote diagnostics.
As Estonia with your wonderful environment for new ideas would be one of our first - or the first - target markets, I would really love to have a short but fruitful conversation with you to understand your requirements, strategy and current potential considerations in order to develop our product compliant with your guidelines.
We, my co-founder Dominique Thaler and I, would be in Tallinn from Sep 3 to 5 (lunchtime each) and more than happy to meet you for a talk.
Would you have time on one of those days?
Thanks in advance for your kind reply and all the best from the Austrian Alps!
--
With kind regards,
Boris J. Fahrnberger
Co-Founder & CEO
Horusmed OÜ
Valukoja 8/2, 2nd floor
Tallinn, 11415, Estonia
Nimi | K.p. | Δ | Viit | Tüüp | Org | Osapooled |
---|---|---|---|---|---|---|
Vastuskiri | 27.08.2024 | 1 | 11.1-12/24/8577-3 | Sissetulev dokument | ta | Horusmed OÜ |
Vastuskiri | 26.08.2024 | 2 | 11.1-12/24/8577-2 | Väljaminev dokument | ta | Horusmed OÜ |