New IOP requirements expand ePA for all and medication process

The Federal Ministry of Health has issued the Third Ordinance Amending the IOP Governance Ordinance, thereby expanding the requirements for the electronic patient record (ePA) for all. The ordinance dated September 9, 2026, was published in the Federal Law Gazette (Bundesgesetzblatt) Part I No. 259, issued in Bonn on September 14, 2026, and comes into force on September 15, 2026. It is signed by the Federal Minister of Health, Carsten Linnemann.

New Requirements 003 and 004

The ordinance supplements Annex 1 of the IOP Governance Ordinance of September 10, 2024 (BGBl. 2024 I No. 279), which was last amended by Article 1 of the Ordinance of June 8, 2026 (BGBl. 2026 I No. 167). New numbers 003 and 004 are inserted after the previous number 002.

Both requirements concern the Guidelines for the implementation of the relevant requirements regarding interoperability between systems and primary systems with regard to the implementation of the digitally supported medication process (dgMP) in version 1.3.0. They refer to the Medication Service (ePA 3.1.3) within the framework of the ePA for all.

Affected Systems and Deadlines

Requirement 003 is addressed to four groups of systems in outpatient and inpatient care:

• Practice Management Systems (PVS)
• Dental Practice Management Systems (ZPVS)
• Hospital Information Systems (KIS)
• Pharmacy Management Systems (AVS)

For these systems, mandatory implementation applies by September 15, 2026; inclusion in the annex takes place by December 31, 2026. The legal basis is Section 355 Paragraph 3 Sentence 2 Number 1 of the Fifth Book of the Social Code.

Requirement 004 concerns primary systems in nursing care. Here, too, mandatory implementation is planned by September 15, 2026, but inclusion in the annex does not take place until September 30, 2027. The legal basis is Section 373 Paragraph 3 and 5 Number 2 of the Fifth Book of the Social Code.

Legal Bases and Entry into Force

The ordinance is based on Section 385 Paragraph 1 Sentence 1, Paragraph 2 Sentence 1 Number 1 and 2, Section 355 Paragraph 1 Sentence 1, Paragraph 3 Sentence 1 and 2 Number 1, Paragraph 9 Sentence 2, as well as Section 373 Paragraph 3 and 5 Number 2 of the Fifth Book of the Social Code – Statutory Health Insurance. The Fifth Book was last amended by Article 1 of the Act of July 24, 2026 (BGBl. 2026 I No. 228).

With the entry into force on September 15, 2026, the new interoperability requirements become binding for the affected systems. Manufacturers of practice, dental, hospital, and pharmacy management systems, as well as primary systems in nursing care, must adapt their products accordingly to make the digitally supported medication process interoperable across the ePA for all.

For insured persons, this represents a further step toward consistent digital medication documentation: the new requirements are intended to ensure that medication data can be exchanged seamlessly between the systems of healthcare providers and nursing care.

Source: Federal Law Gazette Part I, No. 259 of September 14, 2026, pp. 1–2 (official reference: BGBl. 2026 I Nr. 259).