¹ This Act sets out the conditions for the processing of data in the patient's electronic record.

² It determines the measures that support the introduction, dissemination and development of the patient's electronic record.

³ The electronic patient record aims to improve the quality of medical care and therapeutic processes, increase patient safety, increase the effectiveness of the health care system, and encourage the development of Patients' health skills.

⁴ The responsibility of communities, reference communities, portals enabling patients to access their data (access portals), publishers of identification, health professionals and patients is regulated By the provisions applicable to them.

The term is:

A.

Electronic patient record (electronic record): Virtual file which makes it possible to make available online, in the case of concrete treatment, relevant data for this treatment which are taken from the medical file of a patient and recorded in a decentralised manner or data entered by the Patient itself;

B.

Health care professional: A health professional recognized under federal or cantonal law that applies or prescribes medical treatment or provides therapeutic products or other products in the course of medical treatment;

C.

Medical treatment: any act performed by a health professional in order to cure or treat a patient or to prevent, detect or diagnose a disease or to mitigate its symptoms;

D.

Community: Organizational unit of health professionals and their institutions;

E.

Reference community: Additional task community.

¹ The writing of an electronic record requires the written consent of the patient. The patient validly consents only if he expresses his or her will freely and after being duly informed about the manner in which the data are processed and the resulting consequences.

² The patient who has consented to the creation of an electronic record is presumed to accept that health care professionals enter data in the case of medical treatment. Health professionals working for institutions governed by public law or for institutions which carry out a public task entrusted to them by a canton or a municipality are, in this case, authorised to seize and process data In the patient's electronic record.

³ The patient may revoke his or her consent at any time without cause.

⁴ It cannot be forced to make data available on its electronic file.

¹ When a patient has given consent within the meaning of s. 3, an identification number for the electronic record (patient identification number) may be requested from the clearing house referred to in s. 71 of the Federal Act of 20 December 1946 on old-age and survivors' insurance (LAVS) ¹ The patient identification number is randomly generated.

² The patient identification number is recorded in the clearing house identification database.

³ The clearing house may link the patient identification number to the insured number within the meaning of s. 50 C LAVS for quality assurance purposes.

⁴ It may collect fees for the costs related to the assignment and verification of the patient identification number.

⁵ The Federal Council determines the technical and organisational measures to ensure the safety of the issue and the use of the patient identification number.

¹ Communities, reference communities and access portals use the patient identification number as a patient identification feature.

² They may use the insured number within the meaning of s. 50 C LAVS ¹ For:

A.

Request a patient identification number from the clearing house;

B.

Correctly assign the patient identification number.

The patient identification number may not be used outside the scope of this Act except in the area of health. It can then be used as long as a formal legal basis provides for it and the purpose of the use and the persons authorised to use it are defined.

¹ The following persons must have a secure electronic identity to process data in the electronic file:

A.

Patients;

B.

Health care professionals .

² The Federal Council defines the criteria for electronic identity and sets the means of identification; it regulates the means of identification.

¹ The patient can access his or her data.

² It may enter its own data, including its desire for organ donation or advance directives.

¹ Health care professionals can access patient data only to the extent that they have granted access to patients.

² The Federal Council sets out the basic configuration of access rights and the levels of confidentiality that is applicable as soon as an electronic file is created. The patient can adapt it.

³ The patient may grant access rights to certain health professionals or groups or exclude access to certain health care professionals.

⁴ It can adapt the levels of confidentiality of certain data.

⁵ In the event of a medical emergency, health professionals may access the data of the electronic file even without the right of access, unless the patient has adapted the basic configuration and excluded this possibility. The patient must be informed of such access to his or her data.

¹ Communities must perform the following tasks:

A.

Ensure that the data referred to in s. 3, para. 2, are accessible via the electronic file;

B.

Record in a history each data processing.

² The reference communities must carry out the following tasks:

A.

Manage consents and revocations within the meaning of s. 3;

B.

Provide patients with the opportunity to:

1.

Grant rights of access to health professionals within the meaning of s. 9 and to adapt those rights,

2.

Access their own data,

3.

To enter their own data in their electronic files.

³ Historical records must be retained for ten years.

Must be certified by a recognized organization:

A.

Communities and communities of reference;

B.

Access portals;

C.

Publishers of means of identification.

¹ The Federal Council sets the criteria for certification, taking into account international standards in this field and technical progress, in particular as regards:

A.

Applicable standards, standards and integration profiles;

B.

Ensuring the protection and security of data;

C.

Organizational requirements.

² It may enable the Federal Office of Public Health (FOPH) to adapt the criteria referred to in para. 1.

¹ The Federal Council regulates the certification procedure, including:

A.

Conditions for the recognition of certification bodies;

B.

The period of validity of the certification and the conditions for its renewal;

C.

Conditions for withdrawal of certification;

D.

Recognition of certification procedures governed by other laws.

² It can provide certification procedures for isolated components of the IT infrastructure that are required to build communities, reference communities, or access portals.

¹ The OFSP manages the data search services that provide the necessary baseline data for communication between communities, reference communities, and access portals.

² It operates a national contact point for cross-border data consultation.

³ The Federal Council shall lay down the criteria and operating conditions for the data search services and the national contact point.

¹ The Confederation informs the public, health care professionals and other interested parties about the electronic record.

² It coordinates its information activities with those of the cantons.

The Confederation encourages coordination between the cantons and other interested circles by supporting knowledge transfer and exchange of experience.

The Federal Council may conclude international agreements providing for participation in international programmes and projects aimed at promoting electronic data processing and electronic networking in the field of health.

¹ The Federal Department of the Interior shall ensure that the adequacy, effectiveness and efficiency of measures adopted under this Act are periodically assessed.

² At the end of the evaluation, it reports on the results to the Federal Council and submits proposals for further work.

¹ The Federal Council may delegate to third parties the management of the data search service and the operation of the national contact point. It shall monitor these third parties.

² The mandated third parties may receive emoluments from communities, reference communities and access portals for the acquisition of reference data or cross-border access to data.

³ Where costs relating to tasks delegated to third parties are not covered by the emoluments referred to in para. 2, the Confederation grants compensation to these third parties.

⁴ The Federal Council fixes the amount of the fees and sets out the scope and details of the compensation.

¹ The Confederation may, within the limits of the authorised appropriations, grant financial aid for the following purposes:

A.

Create the organizational and legal conditions for building a community or community of reference;

B.

Provide the necessary information technology infrastructure for data processing between communities or communities of reference;

C.

Obtain certification within the meaning of this Act for communities or communities of reference.

² Financial aid shall be granted only if the participation of the cantons or third parties is at least equal to that of the Confederation.

¹ The Federal Assembly shall decide, in the form of a multi-year commitment appropriation, for the maximum amount of the financial assistance of the Confederation within the meaning of Art. 20.

² If the aid requested exceeds available resources, the Federal Department of the Interior shall establish a priority order by ensuring a balance between the regions.

¹ Financial aid within the meaning of Art. 20, para. 1, cover 50 % at most of the costs chargeable.

² Where several federal grants may be claimed for a project, the total financial assistance provided by the Confederation cannot exceed one-half of the total cost.

³ The Federal Council determines the chargeable costs.

¹ Requests for financial assistance should be directed to the FOPH prior to the establishment of a community or community of reference. The latter shall consult the cantons directly concerned. Experts may be invited to review applications.

² Communities and reference communities which have started to form before the entry into force of this Law shall have a period of six months after the entry into force of this Law to file an application.

³ The FOPH allocates financial assistance on the basis of benefit contracts.

¹ A fine of up to 100 000 francs is punished, as long as the Penal Code ¹ Does not provide for a more severe punishment, anyone who knowingly and without the right to the electronic record of a patient.

² If the author acts by negligence, the fine is not more than 10 000 francs.

... ¹

Art. 20 to 23 remain applicable to applications for financial assistance during the period of validity of s. 27, para. 3.

¹ This Law shall be subject to the referendum.

² The Federal Council shall fix the date of entry into force.

³ Art. 20 to 23 have effect three years from their entry into force.