Law to improve the rights of patients

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Basic data
Title: Law to improve the rights of patients
Short title: Patient Rights Act (not official)
Abbreviation: PatRechteG / PatRG (not official)
Type: Federal law
Scope: Federal Republic of Germany
Legal matter: Private law (amendments to the BGB);
Public law / social law (amendments to SGB V)
Issued on: February 20, 2013
( Federal Law Gazette I p. 277 )
Entry into force on: February 26, 2013
GESTA : M024
Weblink: Text of the law
Please note the note on the applicable legal version.

The law to improve the rights of patients is an article law from 2013 and with an area of ​​application for the Federal Republic of Germany , which pursues the goal of creating transparency and legal certainty with regard to the extensive rights of patients that have already existed, existing enforcement deficits in practice, in order to improve the actual enforcement of these rights, at the same time to protect patients in terms of improved health care and, in particular, to provide more support in the event of a malpractice .

For this, the adopted law regulations, among others, to codify the treatment and medical liability in the Civil Code (BGB), to strengthen the patient information , to strengthen procedural rights in medical errors , to strengthen the rights to service providers , to promote error prevention culture and to strengthen patient involvement ago .

A large number of the legal provisions created by this law have since been amended by further amending laws .

history

It was issued on February 20, 2013 by the federal government of the 17th electoral term , represented by the Federal President Joachim Gauck , the Federal Chancellor Angela Merkel , the Federal Minister of Justice Sabine Leutheusser-Schnarrenberger and the Federal Minister of Health Daniel Bahr , on February 25, 2013 announced in the Federal Law Gazette and resigned according to Art. 5 PatRG in force on February 26, 2013.

Task and content

The rights of patients arise from the provisions of the German Civil Code , the special provisions in the Social Security Code , the guidelines of the Federal Joint Committee formed by the National Associations of Statutory Health Insurance Physicians , the German Hospital Society and the Central Association of Health Insurance Funds according to Section 91 of SGB ​​V and special standards such as the Medicines Act as well as further regulations in the professional regulations of the state medical associations and in the federal shell contracts of the self-administration partners .

In order to create more transparency about the applicable law for those involved, the rights of patients were conceptually developed and summarized by the Federal Ministry of Justice (BMJ) and the Federal Ministry of Health (BMG) in cooperation with the Federal Government's patient representative at the time, Wolfgang Zöller comprehensively substantiated in terms of content and structure.

Patient rights, which over the years have largely emerged as judges' rights through case law , are now regulated by law in accordance with Article 1 of the so-called Patient Rights Act (PatRG) ( unofficial designation) by adding Sections 630a to 630h to the German Civil Code (BGB). This should make the legal situation clearer and more manageable and strengthen patient rights. In addition, Article 2 of the Act contains the amendment to Sections 13, 66, 73b, 73c, 99, 135a, 137, 140a, 140f, 140h, 217f, 219a and 219d on statutory health insurance (GKV) of Book Fifth of the Social Code (SGB V), in Article 3 the amendment to Section 4 of the Patient Participation Ordinance (PatBeteiligungsV) and in Article 4 the amendment to Section 17b of the Hospital Financing Act (KHG).

Furthermore, the law to improve the rights of patients describes a supplement to the professional regulations: In Article 4a with regard to §§ 13, 31 and 31a of the Admission Ordinance for Contract Doctors (Doctors-ZV) and in Article 4b with reference to §§ 13 and 31 of the licensing ordinance for contract dentists (Zahnärzte-ZV), as well as in Article 4c in relation to § 6 of the Federal Doctors' Ordinance (BÄO).

The treatment contract was also inserted into the German Civil Code (BGB) as an outline of the service contract . The patient's rights and doctor's liability, also in the event of a treatment error , are bundled and regulated anew. There are now increased requirements for the duty to provide information, which are a prerequisite for effective patient consent. In addition to the creation of new information obligations, the obligation to provide medical documentation has been intensified. The patient now also has the right to an immediate inspection of his patient file . The question of the burden of proof , which is important for the patient in legal disputes , was specified in accordance with the previous principles of case law, in particular when the burden of proof is reversed . In addition, the health insurance companies are obliged to approve treatments more quickly.

Basics of the treatment contract in the BGB

Section 630a BGB standardizes the treatment contract, whichregulatesthe mutual rights and obligations between the treating person on the one hand and the patient on the other inthe case of medical treatment. In addition to the treatment contracts for doctors , dentists , psychological psychotherapists , child and adolescent psychotherapists , thereare also agreements on treatments by members of other health professions , such as alternative practitioners , midwives , physiotherapists , masseurs and medical pool attendants , occupational therapists , podiatrists and speech therapists , treatment contracts within the meaning of Section 630a BGB. Thisdoes not apply tocontracts for treatment services by veterinarians , as they do notcarry out medical treatment, but rather veterinary treatment.

The treatment has according to According to § 630a Abs. 2 BGB according to the generally recognized professional standards existing at the time of the treatment , unless otherwise agreed. This establishes the - also previously applicable - basis of medical liability and the classification of a treatment error by a medical expert .

§ 630b BGB makes it clear that the treatment relationship is an employment relationship, from which it also follows that - as before - the medical service represents a service under service contract law. According to the law on contracts for work and services, the doctor would owe the healing success, which is naturally not possible, since the actual, future course of an illness or injury and its consequences, even in the case of illnesses and injuries that are otherwise considered curable, cannot be foreseen.

Informing the patient

§ 630c BGB obliges the treating person to explain to the patient all essential circumstances of the treatment in an understandable way at the beginning of the treatment, in particular the diagnosis and the therapy . This is the therapeutic education , which was previously also called backup education . Informing the patient should ensure the success of the therapy and, through appropriate advice, enable the patient to behave appropriately at every stage of treatment, protect him from possible dangers and point out possible consequences if he does not follow the medical instructions (lack of compliance ).

With the new concept of information obligations , a formal and factual distinction is made from the information obligations of Section 630e BGB, which relate to the specific treatment and which relate to information on interference and risk , also known as self-determination information .

After the occurrence of liability damage, the responsible practitioner must inform the patient about any identifiable treatment error, either at the request of the patient or in order to avert dangers that may result from incorrect treatment. Without the consent of the practitioner, these confessions associated with this patient information may not be used against the practitioner in criminal or fine proceedings. This restriction does not apply to the use in the civil law enforcement of material and / or immaterial damage claims against the treating party.

Before treatment, the patient must be informed in writing about any additional costs if the treating person knows or if there are sufficient indications that a third party cannot guarantee that the costs will be fully covered. The obligation in writing is new. The violation of this obligation to provide information about the costs can lead to the doctor's fee being void.

The information obligations do not exist if the treatment cannot be postponed, for example after an accident, or if the patient has expressly and not revoked the information or if there are important therapeutic reasons against it, for example if the patient has lost his life or health as a result of the information could endanger.

The information and clarification obligations apply to all medical measures of the treating person, regardless of whether they are standard or additional services, and regardless of who bears the costs of the measure. The information does not constitute a recommendation or legal advice.

Consent of the patient

§ 630d BGB requires thepatient's consent to any medical measure. The patient can only effectively consent if he has beeninformedbeforehand in accordance with the requirements of § 630e BGB. If, for example, medical information is not possible if the patient is unconscious and the patient has not given their consent, both can be dispensed withdue to thepatient'sinability to consent if the medical act corresponds to the presumed will of the patient, unless otherwise a corresponding advance directive to § 1901a before BGB, which does not allow the planned intervention. In the event of a long-term inability to consent, a legal supervisor must be appointed who then decides on the consent.

Educating the patient

§ 630e BGB specifies the medical information obligation of the treating person. Literally:

“The treating person is obliged to inform the patient about all of the circumstances that are essential for the consent. This includes in particular the type, scope, implementation, expected consequences and risks of the measure, as well as its necessity, urgency, suitability and prospects of success with regard to the diagnosis or therapy. When providing information, it is also necessary to point out alternatives to the measure if several medically equally indicated and common methods can lead to significantly different burdens, risks or chances of recovery. "

Furthermore, it is stipulated that the information must be given orally, personally and in good time before an intervention so that the patient can sufficiently reflect on his decision. It would come too late if, for example, it were to take place immediately before a major, particularly risky, intervention. There are exceptions to this, for example in the case of an operation that cannot be postponed or life-saving first aid after an accident, provided that the patient's consent can be accepted.

Documentation and patient record

Section 630f of the German Civil Code obliges the doctor or dentistto keep a patient file and to document all relevant facts in detail- as previouslyregulatedin the professional regulations and in the federal shell contracts. He says:

"The treating person is obliged to record in the patient file all measures and their results that are essential from a technical point of view for current and future treatment, in particular the anamnesis , diagnoses , examinations , examination results, findings , therapies and their effects, interventions and their effects, consent and Clarifications. Doctor's letters are to be included in the patient file. "

Subsequent changes to the paper file as well as to the electronic patient file must reveal the specific content and the exact time of the change.

Right to inspect patient files

§ 630g BGB grants the patient the right to inspect his complete patient file immediately upon request and, if necessary, to receive copies of the folder in paper form or duplicates of the electronic documentation and images in return for reimbursement of expenses. This right of inspection and duplication also applies to his heirs. As a rule, this will be done in the practice or clinic, but this can also be agreed otherwise. Inspection may only be refused "if there are significant therapeutic reasons or other significant third-party rights opposed to inspection".

Burden of proof for liability for treatment and clarification errors

§ 630h BGB is based on the principle that the patient - as before - has to prove a treatment error. However, the burden of proof shifts to the detriment of the treating person if there was a fully controllable risk, the treating person was not sufficiently qualified for the treatment carried out or a gross treatment error was committed.

Burden of proof in the event of patient injury

Paragraph 1 defines the burden of proof in the event of medical malpractice:

"(1) A mistake on the part of the treating person is presumed if a general treatment risk has materialized that was fully controllable for the treating person and that led to injury to life, body or health of the patient."

- Paragraph 1

Whether there is a medical error can be checked and proven with the help of a medical report prepared by a court-appointed medical expert as part of an independent evidence (security) procedure before a civil court, but also in criminal and / or civil law proceedings .

Burden of proof in the event of violation of the duty to provide information

“(2) 1 The treating person has to prove that he has obtained consent in accordance with Section 630d and provided information in accordance with the requirements of Section 630e. 2 If the information does not meet the requirements of Section 630e, the treating person can claim that the patient would have consented to the measure even if the information had been properly provided. "

- Paragraph 2

A clarification error generally leads to ineffectiveness of the consent and can be asserted by the patient. Unless it can be assumed that the doctor would have consented to the treatment measure even after a doctor had informed him about the risk of the damage caused by the treatment or another adverse health treatment.

Burden of proof in case of violation of the documentation obligation

"(3) If the treating person has not recorded a medically necessary essential measure and its result in the patient file contrary to Section 630f Paragraph 1 or Section 2 or if he has not kept the patient file contrary to Section 630f Section 3, it is assumed that he has not taken this measure Has."

- Paragraph 3

Burden of proof in the event of a violation of specialist standards

"(4) If a practitioner was not qualified for the treatment he carried out, it is assumed that the inability to commence the injury to life, body or health was the cause."

- Paragraph 4

The specialist standard is hereby required. If the treating person was an assistant doctor, then the burden of proof is reversed, i.e. the treating person then has to prove that he / she has complied with the professional standards.

Burden of proof in the event of a gross malpractice

“(5) 1 If there is a gross malpractice and if it is fundamentally capable of causing injury to life, limb or health of the type that actually occurred, it is assumed that the malpractice was the cause of this injury. 2 This also applies if the treating person has failed to collect or secure a medically required finding in good time, provided that the finding would have produced a result with sufficient probability that would have given rise to further measures, and if the failure to take such measures was gross would have been faulty. "

- Paragraph 5

Deadlines for benefit commitments by health insurance companies

Section 13 (3) SGB V has been supplemented by a new paragraph 3a.

"(3a) 1 The health insurance company must promptly submit an application for benefits, at the latest within three weeks after receipt of the application or in cases in which an expert opinion, in particular the medical service of the health insurance (medical service), is obtained within to be decided five weeks after receipt of the application. 2 If the health insurance company considers an expert opinion to be necessary, it must obtain it immediately and inform the beneficiaries of this. 3 The medical service provides an expert opinion within three weeks. 4 If the expert procedure for dentists provided for in the federal contract is carried out, the health insurance company must make a decision within six weeks of receipt of the application; the reviewer gives his opinion within four weeks. 5 If the health insurance company cannot meet the deadlines set out in sentence 1 or sentence 4, it will notify the beneficiaries in writing in good time, stating the reasons. 6 If no sufficient reason is given, the service is considered approved after the deadline. 7 If beneficiaries procure the required service themselves after the deadline, the health insurance company is obliged to reimburse the costs incurred as a result. 8 The health insurance company reports annually to the National Association of Health Insurance Funds on the number of cases in which deadlines were not met or reimbursements were made. 9 Sections 14, 15 of the ninth book on the clarification of responsibilities and reimbursement of self-procured services apply to services for medical rehabilitation . "

- Paragraph 3a

This new regulation is intended to eliminate treatment delays due to lengthy administrative procedures.

(This regulation is no longer up-to-date in the version amended by the Patient Rights Act.)

Support for the insured in the event of malpractice

The previously existing “optional” regulation in Section 66 Fifth Book of the Social Code (SGB V) has been changed into a “target regulation”.

"The [statutory] health insurance companies should support the insured in pursuing claims for damages which arose from the use of insurance benefits from malpractice and which are not transferred to the health insurance companies in accordance with Section 116 of Book 10 [Social Code] [(SGB X)]."

As a rule, this is done, for example, by making a medical report from the Medical Service of the Health Insurance Fund (MDK). The legislative expression “should” means that the insurance service provider is only allowed a narrow margin of discretion in making its decision to support the policyholder.

(This regulation is no longer up-to-date in the version amended by the Patient Rights Act.)

Revocation of participation in the family doctor model

Section 73b (3) SGB V describes the so-called family doctor-centered care in which an insured person can register. The provision has been expanded to include a revocation clause, according to which the insured can revoke his / her membership within two weeks of submitting the declaration of participation.

(This regulation is no longer up-to-date in the version amended by the Patient Rights Act.)

Quality and complaint management

According to the amended provisions of Section 135a (2) No. 2 SGB V, hospitals in Germany are legally obliged to set up patient-oriented complaint management in addition to an in-house quality management system. This should serve to ensure sustainable quality and, as part of the regulations for strengthening patient safety , [contribute] to the fact that the patient's point of view and experiences can flow into the hospital's risk and error management ".

(This regulation is no longer up-to-date in the version amended by the Patient Rights Act.)

Cross-border contact point

In § 219d SGB ​​V, the EU directive 2011/24 is implemented in national law. The main tasks of the national contact point are to provide EU citizens with information about the national health care providers. This should the German Hospital Association , the National Association of Statutory Health Insurance Physicians and dentists' Confederation and the private health insurance of a written contract, and bear the costs.

(This regulation is no longer up-to-date in the version amended by the Patient Rights Act.)

Advocacy

Patient involvement

The ordinance on the participation of patients in statutory health insurance (Patient Participation Ordinance - PatBeteiligungsV) regulates the interests of patients and the self-help of chronically ill and handicapped people in order to exercise the rights of participation mentioned in Section 140f (2) and (3) SGB V at the federal level Within the meaning of Section 135, Paragraph 1 and Section 137c, Paragraph 1 of the Social Code Book V, self- government agencies of the organizations named in Section 2, Paragraph 1 and recognized according to Section 3 of the Patients Participation Ordinance (PatBeteiligungsV), such as

  1. the German Disability Council ,
  2. the Federal Working Group of Patient Agencies ,
  3. the German working group self-help groups e. V. and
  4. the Federation of German Consumer Organizations V.,

to participate in "the resolutions of the Federal Joint Committee (G-BA) named in Section 140f, Paragraph 2, Clause 5 of Book Five of the Social Security Code .

The Federal Joint Committee (G-BA) develops the guidelines and resolutions for quality assurance in medicine .

Consolidation of financial planning for hospitals

Quality assurance and cross-facility error reporting systems

In the law on the economic security of hospitals and on the regulation of hospital care rates (Hospital Financing Act - KHG), section 3 of the provisions on hospital care rates in Section 17b (1) sentence 5 as part of the introduction of a flat-rate remuneration system for DRG hospitals for the participation of Hospitals in quality assurance measures on the basis of § 137 SGB ​​V "and the participation of entire hospitals or essential parts of the facilities in cross-facility error reporting systems, provided that these correspond to the stipulations of the Federal Joint Committee according to § 137 paragraph 1d sentence 3 of the fifth book of the Social Code," the Agreement of surcharges fixed.

The creation of financial incentives, for example in the context of quality surcharges, is intended to promote the operational introduction of risk management and error reporting and avoidance systems, but also the acceptance of such risk and error management among the professional groups concerned and their participation.

Medical liability insurance

Article 4c of the Law on Patients 'Rights adds in Section 6 (1) No. 5 of the Federal Doctors' Ordinance (BÄO) the basis for authorizing a doctor or dentist to suspend his license to practice medicine if the doctor has not taken out any professional liability insurance or has only taken out insufficient professional liability insurance despite the corresponding obligation. If the license to practice medicine is inactive, the doctor may not practice his profession. This is to prevent patients from contacting a doctor who is not or insufficiently insured and against whom they cannot realize a possible claim for damages.

Not recorded

Among other things, regulations were not included in the Patient Rights Act

  • to create an obligation to treat contract (dental) doctors for those insured with private health insurance in the basic and standard tariff,
  • to the obligation to issue a patient letter after every medical intervention,
  • for routine delivery of a patient receipt,
  • for no-fault liability in the event of treatment errors ,
  • to establish a patient compensation fund,
  • for the introduction of a national error register and
  • for the mandatory 24-hour reflection period before the provision of IGel services .

criticism

At the 2014 Judges and Public Prosecutor's Day in Weimar, the patient rights law was discussed controversially. It is politically motivated and has an impact on the public. The newly introduced obligation to disclose errors encourages a “culture of mistrust”. On the other hand, an even greater use of evidence-based instruments was called for. Like any other area, medicine has to submit to external controls. Due to the “overdose of the law”, however, there is a risk that doctors either refrain from sensible treatment in order to minimize risk and avoid liability claims - or protect themselves with overdiagnosis. Recently, the emphasis on patient rights has triggered legal inflation with the consequence of defensive medicine.

A distinction was made between three types of “suffering from the law”: When the law prescribes something that the doctor considers medically nonsensical, when he cannot do something meaningful and when he has to do something meaningful under unfavorable conditions.

The duty to inform should be limited, since one now has to inform about risks that occur with a probability of less than one per thousand.

Web links

Individual evidence

  1. ↑ Federal Ministry of Health (BMG): Patient rights on the home straight - Patient Rights Act passed by the Bundestag. Press release. November 29, 2012, accessed April 15, 2015 .
  2. ↑ Federal Ministry of Health (BMG): Patient Rights Act passes the Federal Council. Press release. February 1, 2013, accessed April 15, 2015 .
  3. ↑ a b Law for the Improvement of Patients' Rights, of February 20, 2013. (PDF; 83.97 kB) In: Bundesgesetzblatt (BGBl.). Bundesanzeiger Verlag , February 25, 2013, p. 277 , accessed on April 15, 2015 .
  4. ↑ Federal Ministry of Justice (BMJ): Starting shot for the new patient rights law and the new regulations on compulsory medical treatment. Press release (with further information and links). (No longer available online.) February 26, 2013, formerly in the original ; accessed on April 15, 2015 .  ( Page no longer available , search in web archives )@1@ 2Template: Dead Link / www.bmjv.de
  5. ↑ Martin Rehborn: The patient rights law. ( Memento from March 15, 2019 in the Internet Archive ) GesR Legal journal for health law, 12th year, issue 5/2013, De Gruyter Verlag, ISSN 1610-1197, pp. 257-272 (PDF, 16 pp., 353 kB) .
  6. ^ The Federal Government Commissioner for Patients' Issues : Die Person, Wolfgang Zöller. Web presence of the former patient representative who was in office from November 2009 to October 2013. Archived from the original on October 27, 2013 ; accessed on April 15, 2015 .
  7. ^ Federal Ministry of Justice (BMJ) and Federal Ministry of Health (BMG): Patients' rights in Germany. (PDF; 110.8 kB) Basic paper. Archived from the original on September 23, 2015 ; accessed on April 15, 2015 .
  8. ^ German Bundestag (DBT): Draft of a law to improve the rights of patients. (PDF; 1.06 MB) draft law of the federal government. In: Drucksache 17/10488. August 15, 2012, p. 21 , accessed April 15, 2015 (quotation).
  9. ↑ Patient protection association "Doctors cannot refuse access to files". ( Memento from June 12, 2018 in the Internet Archive ) In: Spiegel-Online, March 14, 2014.
  10. ↑ Information sheet on patient rights to inspect files (PDF, 5 pages, 145 kB)
  11. ^ German Bundestag (DBT): Draft of a law to improve the rights of patients. (PDF; 1.06 MB) draft law of the federal government. In: Drucksache 17/10488. August 15, 2012, p. 33 , accessed April 15, 2015 (quotation).
  12. ↑ Doctors' suffering from law - arithmetic and documentation instead of healing and helping? 21st German Judges and Public Prosecutor's Day 2014 (archived). In: Program. Archived from the original on April 27, 2014 ; accessed on April 15, 2015 .
  13. ↑ Robert Büssow: How laws lead to defensive medicine. In: ÄrzteZeitung . April 7, 2014, accessed April 15, 2015 .

annotation

  1. ↑ a b Quote of the legislative amendments brought about by the Patient Rights Act .