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RS 816.111 Ordinance of the DFI of 22 March 2017 on the electronic patient record (ODEP-DFI)

Original Language Title: RS 816.111 Ordonnance du DFI du 22 mars 2017 sur le dossier électronique du patient (ODEP-DFI)

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816.111

DFI's Electronic Patient Record Order

(ODEP-DFI)

March 22, 2017 (Status on April 15, 2017)

The Department F é Uproar from I N T é R I E Ur ( DFI ) ,

Having regard to art. 5, para. 2, 10, para. 3 to 5, 11, 12, al. 4, 18, 19, 22, para. 2, 28, para. 5, 30, para. 2 and 3, 31, para. 2 and 3, and 41, para. 2, of the order of 22 March 2017 on the electronic patient record (ODEP) 1 ,

Stops:

Art. 1 Patient identification number

The composition of the patient identification number and the calculation of the control key within the meaning of s. 5, para. 2, ODEP are defined in Annex 1.

Art. 2 Technical and organizational certification criteria for communities and reference communities

1 Technical and organizational certification criteria applicable to communities and reference communities within the meaning of s. 30, para. 2, ODEP are defined in Annex 2.

2 The Federal Office of Public Health (OFSP) can adapt them to technical progress.

Art. 3 Metadata

1 Metadata referred to in s. 10, para. 3, let. A, ODEP are listed in Annex 3.

2 The FOPH can adapt them to technical progress.

Art. 4 Exchange Formats

1 The exchange formats referred to in s. 10, para. 3, let. B, ODEP are listed in Annex 4.

2 The FOPH can adapt them to technical progress.

Art. 5 Integration profiles

1 Schedule 5 defines, pursuant to s. 10, para. 3, let. C and d, ODEP:

A.
Integration profiles;
B.
National adaptations of integration profiles;
C.
National integration profiles.

2 The FOPH may adapt the requirements referred to in para. 1.

Art. 6 Evaluation and Research

1 Schedule 6 indicates, pursuant to s. 22, para. 2, ODEP, the data that communities and communities of reference must provide and the time frames in which they must do so.

2 The FOPH may adapt the data referred to in para. 1.

Art. 7 Minimum Personnel Requirements

The minimum requirements for the qualification of personnel who perform the certifications within the meaning of s. 28, para. 5, ODEP are defined in Annex 7.

Art. 8 Technical and organizational certification criteria for publishers of means of identification

1 The technical and organisational certification criteria applicable to publishers of means of identification within the meaning of Art. 31, para. 2, ODEP are defined in Annex 8.

2 The FOPH can adapt them to technical progress.

Art. Entry into force

This Order comes into force on April 15, 2017.

Annex 1

(art. 1)

Patient identification number

1 Composition of patient identification number

1.1
The patient identification number is:
1.1.1
A two-character country code;
1.1.2
A five-digit number to designate the registered participant "Federal Office of Public Health";
1.1.3
A number to a number to refer to the area of application "electronic patient record";
1.1.4
A nine-digit number to identify the patient;
1.1.5
A control key to a number.

Position

N 1

N 2

N 3

N 4

N 5

N 6

N 7

N 8

N 9

N 10

N 11

N 12

N 13

N 14

N 15

N 16

N 17

N 18

Designation

Country Code

Participant number

DEP

Identification Number

Control key

Value

7

6

1

3

3

7

6

1

I 1

I 2

I 3

I 4

I 5

I 6

I 7

I 8

I 9

C

2 Calculation of the control key

2.1
The control key is the last digit (N 18 ) The patient identification number. It is obtained by the following operations:
2.1.1
Multiply alternately by 3 and 1 each number by proceeding from right to left, from the penultimate (N N-1 );
2.1.2
Then add the resulting products:

Intermediate total = (3∙N N-1 ) + (1∙N N-2 ) + (3∙N N-3 ) ...;

2.1.3
Finally determine the value (control key x N ) Which, added to the intermediate total, will give the next multiple of 10.
2.2
If the intermediate total is already a multiple of 10, the control key is 0.

3 Illustration of the calculation

Position

N 1

N 2

N 3

N 4

N 5

N 6

N 7

N 8

N 9

N 10

N 11

N 12

N 13

N 14

N 15

N 16

N 17

N 18

No control key number

7

6

1

3

3

7

6

1

1

2

3

4

5

6

7

8

9

Step 1:

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

Multiplication with factors

3

1

3

1

3

1

3

1

3

1

3

1

3

1

3

1

3

Step 2:

=

=

=

=

=

=

=

=

=

=

=

=

=

=

=

=

=

Addition of products to obtain the intermediate total

21

6

3

3

9

7

18

1

3

2

9

4

15

6

21

8

27

= 163

Step 3: subtract the result of step 2 from the multiple of 10 superior (170) = control key (7)

Control key number

7

6

1

3

3

7

6

1

1

2

3

4

5

6

7

8

9

7

Status April 15, 2017

Annex 2

(art. 2)

Technical and organizational certification criteria for communities and reference communities 1

1 The text is not published in the RO. Order: Office fédéral de la santé publique OFSP, Schwarzenburgstrasse 157, 3003 Berne. Consultation: www.ehealth.admin.ch.

Status April 15, 2017

Annex 3

(art. 3)

Metadata 1

1 The text is not published in the OR and is not translated into official languages. Order: Office fédéral de la santé publique OFSP, Schwarzenburgstrasse 157, 3003 Berne. Consultation: www.ehealth.admin.ch.

Status April 15, 2017

Annex 4

(art. 4)

Exchange Formats 1

1 The text is not published in the RO. Order: Office fédéral de la santé publique OFSP, Schwarzenburgstrasse 157, 3003 Berne. Consultation: www.ehealth.admin.ch.

Status April 15, 2017

Annex 5

(art. 5)

Integration profiles 1

1 IHE Integration Profiles 2

Integration Profile

Technical Document

Transactions

National adaptations

ATNA

IHE IT Infrastructure Technical Framework, Volume 2a (ITI TF-2a), Revision 13.0

Authenticate Node [ITI-19]

Record Audit Event [ITI 20]

Yes

CT

IHE IT Infrastructure Technical Framework, Volume 2a (ITI TF-2a), Revision 13.0

Maintain Time [ITI-1]

Yes

HPD

IHE IT Infrastructure Technical Framework, Supplement, Healthcare Provider Directory (HPD) Revision 1.6-2015-08-31

Provider Information Query [ITI-58]

Provider Information Feed [ITI-59]

Provider Information Delta Download (CH:PIDD)

Yes

PDQV3

IHE IT Infrastructure Technical Framework, Volume 2b (ITI TF-2b), Revision 13.0

Patient Demographics Query HL7 V3 [ITI-47]

Yes

PIXV3

IHE IT Infrastructure Technical Framework, Volume 2b (ITI TF-2b), Revision 13.0

Patient Identity Feed HL7 V3 [ITI-44]

PIXV3 Query [ITI-45]

PIXV3 Update Notification [ITI-46]

Yes

SVS

IHE IT Infrastructure Technical Framework, Volume 2b (ITI TF-2b), Revision 13.0

Retrieve Value Set [ITI-48]

Retrieve Multiple Value Sets [ITI-60]

No

XCA

IHE IT Infrastructure Technical Framework, Volume 2b (ITI TF-2b), Revision 13.0

Cross Gateway Query [ITI-38]

Cross Gateway Retrieve [ITI-39]

No

XCA-I

IHE Radiology Technical Framework, Volume 3 (RAD-TF-3), Revision 15.0

Cross Gateway Retrieve Image Document Set [RAD-75]

No

XCPD

IHE IT Infrastructure Technical Framework, Volume 2b (ITI TF-2b), Revision 13.0

Cross Gateway Patient Discovery [ITI-55]

Yes

XDS.b

IHE IT Infrastructure Technical Framework, Volume 2a (ITI TF-2a), Revision 13.0

Registry Stored Query [ITI-18]

Yes

IHE IT Infrastructure Technical Framework, Volume 2b (ITI TF-2b), Revision 13.0

Provide and Register Document Set-b [ITI-41]

Register Document Set-b [ITI-42]

Retrieve Document Set [ITI-43]

Patient Identity Feed HL7v3 [ITI-44]

Register On-Demand Document Entry [ITI-61]

XDS-I

IHE Radiology Technical Framework, Volume 2 (RAD-TF-2), Revision 15.0

WADO Retrieve [RAD-55]

Retrieve Imaging Document Set [RAD-69]

No

XDM

IHE IT Infrastructure Technical Framework, Volume 2a (ITI TF-2b), Revision 13.0

Distribute Document Set on Media [ITI-32]

No

XDS Metadata Update

IHE IT Infrastructure Technical Framework Supplement-XDS Metadata Update, Revision 1.8-2016-09-09

Update Document Set [ITI-57]

Delete Document Set [ITI-62]

No

XUA

IHE IT Infrastructure Technical Framework, Volume 2b (ITI TF-2b), Revision 13.0

User Authenticate

Get X-User Assertion

Provide X-User Assertion [ITI-40]

Yes

2 National integration profiles

CH: ADR

Authorization Decision Request

Authorization Decision Request (CH:ADR)

CH: PPQ

Privacy Policy Query

Privacy Policy Query (CH:PPQ)

1 The integration profiles mentioned can be viewed free of charge from the OFSP, Schwarzenburgstrasse 157, 3003 Berne, www.ehealth.admin.ch or at IHE Switzerland, Oberstrasse 222, 9014 Saint-Gall, www.ihe-suisse.ch. National adaptations Integration profiles and national integration profiles are not published in the RO. They can be obtained from the OFSP, Schwarzenburgstrasse 157, 3003 Berne, or be consulted at the following address: www.ehealth.admin.ch. Integration profiles are not translated into official languages.
2 IHE is the acronym for Integrating the Healthcare Enterprise (Interoperability of health systems)

Status April 15, 2017

Annex 6

(art. 6)

Evaluation and Research 1

1 The data requirements for evaluation and research are not published in the RO. Order: Office fédéral de la santé publique OFSP, Schwarzenburgstrasse 157, 3003 Berne. Consultation: www.ehealth.admin.ch.

Status April 15, 2017

Annex 7

(art. 7)

Minimum requirements for qualification of personnel of certification bodies

1 Certification of communities and reference communities or access portals

1.1
The certification body must prove that part of the staff has the following qualifications:
1.1.1
Knowledge of medical informatics: a practical activity of at least two years in the field of medical informatics must be attested or a diploma from a high school or a specialised high school attesting to studies of at least one year, With the main subject matter of medical informatics, must be provided;
1.1.2
Knowledge of the right to data protection: a practical activity of at least two years in the field of data protection must be attested or a diploma from a high school or a specialized high school attesting to the studies of a At least the right of data protection, with the main subject matter, must be provided;
1.1.3
Knowledge in the field of computer security: a practical activity of at least two years in the field of computer security must be certified or a diploma from a high school or a specialized high school attesting to studies At least one year, with the main subject matter of computer security, must be provided;
1.1.4
Auditor training according to ISO/IEC 17021:2006 1 ;
1.1.5
Auditor training according to ISO/IEC 27006:2011 2 .
1.2
The certification body must prove that it has qualified personnel for each of the areas it covers. Evaluation can be conducted by an interdisciplinary team.

2 Certification of publishers of means of identification

2.1
The certification body must prove that part of the staff has the following qualifications:
2.1.1
Knowledge in the field of identification and authentication: a practical activity of at least two years in the field of identification and authentication must be attested or a diploma from a high school or high school Specialising in studies of at least one year, with the main subject matter identification and authentication, must be provided;
2.1.2
Knowledge of the right to data protection: a practical activity of at least two years in the field of data protection must be attested or a diploma from a high school or a specialized high school attesting to the studies of a At least the right of data protection, with the main subject matter, must be provided;
2.1.3
Knowledge in the field of computer security: a practical activity of at least two years in the field of computer security must be certified or a diploma from a high school or a specialized high school attesting to studies At least one year, with the main subject matter of computer security, must be provided;
2.1.4
Auditor training according to ISO/IEC 17021:2006 3 ;
2.1.5
Auditor training according to ISO/IEC 27006:2011 4 .
2.2
The certification body must prove that it has qualified personnel for each of the areas it covers. Evaluation can be conducted by an interdisciplinary team.

1 The standard can be consulted at the OFSP, Schwarzenburgstrasse 157, 3003 Berne
2 The standard can be consulted at the OFSP, Schwarzenburgstrasse 157, 3003 Berne
3 The standard can be obtained against payment from the Swiss Standards Association (www.snv.ch) or be consulted free of charge from the OFSP, Schwarzenburgstrasse 157, 3003 Berne.
4 The standard can be obtained against payment from the Swiss Standards Association (www.snv.ch) or be consulted free of charge from the OFSP, Schwarzenburgstrasse 157, 3003 Berne.

Status April 15, 2017

Annex 8

(art. 8)

Technical and organizational certification criteria for publishers of means of identification 1

1 The text is not published in the OR and is not translated into official languages. Order: Office fédéral de la santé publique OFSP, Schwarzenburgstrasse 157, 3003 Berne. Consultation: www.ehealth.admin.ch.

Status April 15, 2017