The Legal Division is engaged in activities in the field of law in medicine, civil law, commercial law and labour law. The division handles agreements on cooperation with healthcare providers and agreements on clinical trials.
Furthermore, the Legal Division:
Handles legal matters of IKEM including representation of IKEM before courts and administrative bodies;
Evaluates agreements in terms of law;
Coordinates and implements internal legislative activities;
Submits legal opinions and provides consultations;
Administers the registry (records) of all concluded agreements at IKEM.
Rules of Electronical Signing of Documents through Qualified Certificates at IKEM
The Institute of Clinical and Experimental Medicine offers optional electronic signing of contractual documents through a qualified certificate for recognized electronic signatures, in compliance with Art. 3 (11) of eIDAS no. 910/2014 of 23 July 2014, and Section 6 (2) of Act no. 297/2016 Coll., on Trust-Creating Services for Electronic Transactions, as amended.
A certified electronic signature must meet the following requirements:
a) An unambiguous link to the signing person shall be provided;
b) Identification of the signing person shall be possible;
c) The signature shall be made of data for electronic signature creation which the signing person can use with a high level of trust and under their exclusive control;
d) The signature is attached to the information signed by it in a way allowing detection of any subsequent alteration of the information.
A certified electronic signature shall be created by:
a) A qualified means for electronic signature creation; and based on
b) A qualified certificate for electronic signatures.
The qualified means is represented by:
a) A security device for electronic signature creation on the basis of the asymmetrical cryptography principles, meeting the requirements of Annex II of eIDAS Regulation;
b) Most often by chip cards or tokens.
A survey of European certification authorities is available on eIDAS Dashboard (europa.eu).
Certificates meeting neither the requirements of European Regulation eIDAS no. 910/2014 of 23 July 2014, nor the provisions of Act no. 297/2016 Coll., on Trust-Creating Services for Electronic Transactions, as amended, include:
a) DOCUSIGN electronic signatures, which are not based on a qualified certificate. This signature was created by the commercial service called DocuSign and the PDF document itself does not contain any data allowing for independent verification of data integrity (i.e. that the document content has remained unchanged after its signing) and the signing person´s identity (i.e. that the document has actually been signed by a representative of the counterparty). The document only includes an ID referring to data on the DocuSign server, where a user account is needed to be able to perform the needed verification. This “signature“ by DocuSign meets neither the requirements of the European eIDAS Regulation, nor the provisions of the Czech Act no. 297/2016 Coll.;
b) Commercial certificate-based certified signatures.
The following is therefore necessary from the process point of view:
1. In the case of contracts in the electronic format the counterparty shall provide the contract wording (including potential annexes) saved in the PDF file format with an electronic signature (i.e. a signature based on a qualified certificate).
2. The PDF file shall include a machine- and human-readable text layer (i.e. not only a scanned image of the text).
3. The qualified electronic signature shall belong of the person explicitly named in the contract as the contracting party representative (i.e. if the company director is the contracting party representative named in the contract then the document may not be provided with an electronic signature of for example the head of the IT department of that company).
4. The signing person attaching their electronic signature may not set the PDF file security so that attachment of other electronic signatures is not possible anymore. The qualified electronic signature must be attached to the PDF fil in the form of “signing”, not in the form of “certification” (certain software allows certification instead of signing, which makes subsequent attachment of electronic signatures of the other contracting parties impossible).
5. The signing person attaching their electronic signature may not set the PDF file security so that the file cannot be printed or the text or its part(s) copied (for a contract to come to legal force, IKEM is obliged to publish its depersonalized version in the Register of Contracts. The preparation of the partly redacted contract version is unnecessarily complicated in the case of documents with prohibited printing and text copying).