DISCLAIMER (MANDATORY – DO NOT DELETE)
The following document is a model template for educational purposes only and does not constitute legal or medical advice. Use of this template does not create an attorney-client or physician-patient relationship. California and federal requirements governing informed consent and medical malpractice are complex and frequently updated; therefore, a qualified California-licensed attorney and the treating clinician must review, customize, and approve this form before implementation.
PATIENT CONSENT TO TREATMENT AGREEMENT
(California – Comprehensive Informed Consent Form)
[// GUIDANCE: Insert institution logo/contact information here]
Effective Date: [DATE]
Provider Entity: [LEGAL NAME OF HOSPITAL/CLINIC/PHYSICIAN GROUP] (“Provider”)
Treating Clinician: [NAME & LICENSE NO.]
Patient: [LEGAL NAME] (“Patient”)
Authorized Representative (if any): [NAME & RELATIONSHIP] (“Representative”)
Jurisdiction/Governing Law: State of California (“CA”)
TABLE OF CONTENTS
I. Document Header
II. Definitions
III. Operative Provisions
IV. Representations & Warranties
V. Covenants & Restrictions
VI. Default & Remedies
VII. Risk Allocation
VIII. Dispute Resolution
IX. General Provisions
X. Execution Block
I. DOCUMENT HEADER
A. Purpose. This Agreement records the informed consent of Patient (or Representative) for the performance of one or more medical treatments, procedures, or services (collectively, “Treatment”) by Provider, in compliance with applicable California informed-consent standards.
B. Consideration. In consideration of Provider’s agreement to furnish Treatment and related services, and other good and valuable consideration, the sufficiency of which the Parties acknowledge, the Parties agree as set forth herein.
C. Acknowledgment of Receipt. Patient acknowledges receipt of a copy of this Agreement and that the provisions have been explained in language Patient understands.
II. DEFINITIONS
“Adverse Event” – Any unanticipated injury or complication arising in connection with Treatment that may require further medical intervention.
“Capacity” – The ability to understand the nature, risks, benefits, and alternatives of Treatment and to make and communicate a decision, as determined consistent with CA Prob. Code §§ 810–813.
“Confidential Information” – Individually identifiable health information subject to the California Confidentiality of Medical Information Act (CMIA) and the federal Health Insurance Portability and Accountability Act (HIPAA).
“Emergency Condition” – A condition in which delay in Treatment would jeopardize Patient’s life, health, or bodily function.
“Informed Consent” – Voluntary authorization given by Patient or Representative after being provided disclosure of: (i) diagnosis; (ii) proposed Treatment; (iii) material risks and expected benefits; (iv) reasonable alternatives (including the option of no treatment); and (v) answers to Patient questions in a manner consistent with CA professional standards of practice.
“Malpractice Limits” – The statutory limitations on non-economic damages for professional negligence under applicable California law (currently Civ. Code § 3333.2).
“Parties” – Collectively, Provider, Patient, and Representative (if any).
“Protected Health Information (PHI)” – As defined in 45 C.F.R. § 160.103.
[// GUIDANCE: Add additional definitions as needed for specialized treatments.]
III. OPERATIVE PROVISIONS
3.1 Description of Treatment.
a. Nature of Treatment: [DETAILED DESCRIPTION].
b. Expected Benefits: [DESCRIPTION].
c. Material Risks & Complications: [List OR attach Schedule 1].
d. Reasonable Alternatives: [List].
e. Consequences of Declining/Delaying Treatment: [List].
3.2 Disclosure. Provider has disclosed, and Patient acknowledges receipt of, information sufficient to satisfy California’s professional disclosure requirements.
3.3 Voluntary Consent. Patient confirms that consent is given voluntarily and may be withdrawn in writing at any time prior to performance of Treatment, subject to Section 6 (Default & Remedies).
3.4 Right to Questions. Patient was encouraged to ask questions, and all questions were answered to Patient’s satisfaction.
3.5 Financial Responsibility. Patient agrees to be financially responsible for charges associated with Treatment not covered by insurance. [PLACEHOLDER – insert detailed billing policy].
3.6 Confidentiality & Privacy. Provider will use Confidential Information solely for Treatment, payment, and healthcare operations, consistent with HIPAA and CMIA. Patient consents to such use and acknowledges receipt of Provider’s Notice of Privacy Practices.
3.7 Capacity Verification. Provider has verified Patient’s Capacity, or if lacking, obtained consent from Representative in compliance with CA Prob. Code § 4600 et seq.
3.8 Emergency Treatment Exception. In an Emergency Condition where informed consent cannot practicably be obtained, Provider may proceed under applicable emergency exceptions.
IV. REPRESENTATIONS & WARRANTIES
4.1 Patient/Representative Representations.
a. Authority & Identity. Representative warrants legal authority to act for Patient.
b. Accuracy of Information. All information furnished is true, complete, and accurate.
c. Understanding. Patient/Representative represents understanding of this Agreement.
4.2 Provider Representations.
a. Licensure & Qualifications. Provider and Treating Clinician are duly licensed in CA.
b. Standard of Care. Treatment will be rendered consistent with prevailing professional standards.
c. Disclosure Compliance. Provider has made disclosures sufficient for Informed Consent.
4.3 Survival. Sections 4.1–4.2 survive completion or termination of Treatment to the extent necessary to enforce the Parties’ rights.
V. COVENANTS & RESTRICTIONS
5.1 Patient Covenants.
a. Cooperation. Patient shall cooperate with pre- and post-Treatment instructions.
b. Notification. Patient must promptly notify Provider of any Adverse Event or change in condition.
5.2 Provider Covenants.
a. Recordkeeping. Provider shall maintain medical records in accordance with 22 Cal. Code Regs. § 70751 and HIPAA.
b. Insurance. Provider shall maintain professional liability insurance meeting or exceeding Malpractice Limits.
VI. DEFAULT & REMEDIES
6.1 Events of Default.
a. Non-Payment by Patient.
b. Material Misrepresentation by any Party.
c. Withdrawal of Mandatory Consent during an ongoing Procedure (except as permitted at law).
6.2 Notice & Cure. The non-defaulting Party must provide written notice specifying the default. The defaulting Party shall have:
• Ten (10) calendar days to cure a monetary default; or
• A reasonable period, not to exceed fifteen (15) calendar days, to cure any non-monetary default.
6.3 Remedies.
a. Suspension or termination of non-emergency Treatment.
b. Recovery of reasonable collection costs, including attorneys’ fees, for unpaid charges.
c. Any other remedy available at law or equity, subject to Section 7 (Risk Allocation).
VII. RISK ALLOCATION
7.1 Indemnification. Patient agrees to indemnify and hold harmless Provider and its personnel from claims arising out of Patient’s breach of this Agreement or failure to follow medical instructions, except to the extent caused by Provider’s negligence or willful misconduct (“Informed Consent Protection”).
7.2 Limitation of Liability. Nothing in this Agreement limits Provider’s liability for professional negligence beyond the statutory Malpractice Limits.
7.3 Force Majeure. Provider shall not be liable for delay or failure to perform due to events beyond its reasonable control (e.g., natural disaster, pandemic, governmental order), provided Provider exercises commercially reasonable efforts to mitigate the effect of such events.
VIII. DISPUTE RESOLUTION
8.1 Governing Law. This Agreement and any dispute hereunder shall be governed by the laws of the State of California, without regard to conflict-of-laws principles.
8.2 Forum Selection. Exclusive venue shall lie in the state courts of the county in which Treatment is rendered, except as provided in Section 8.3.
8.3 Optional Arbitration. [SELECT ONE]
☐ Patient elects binding arbitration pursuant to CA Code Civ. Proc. § 1280 et seq. The arbitration shall be administered by [AAA/JAMS/OTHER] under its health-care rules.
☐ Patient declines arbitration; disputes will be resolved in court.
[// GUIDANCE: California requires specific font sizes and warnings for healthcare arbitration agreements (see Cal. Code Civ. Proc. § 1295). Attach a separate stand-alone arbitration agreement if selected.]
8.4 Jury Trial. If arbitration is not elected, the Parties acknowledge the constitutional right to a jury trial but do not waive that right herein.
8.5 Injunctive Relief. Either Party may seek limited injunctive relief only to protect PHI or to enforce non-disclosure obligations; all other equitable remedies are subject to Section 8.3.
IX. GENERAL PROVISIONS
9.1 Amendments & Waivers. Any amendment or waiver must be in a signed writing referencing this Agreement.
9.2 Assignment. Patient may not assign rights or delegate duties without Provider’s prior written consent. Provider may assign to a successor entity in connection with a merger, acquisition, or sale of substantially all assets.
9.3 Successors & Assigns. This Agreement binds and benefits the Parties and their lawful successors and assigns.
9.4 Severability. If any provision is held invalid, the remaining provisions shall remain enforceable, and the invalid provision shall be reformed to the minimum extent necessary to comply with applicable law.
9.5 Integration. This Agreement, together with any schedules, attachments, and Provider’s Notice of Privacy Practices, constitutes the entire agreement regarding the subject matter and supersedes all prior oral or written understandings.
9.6 Counterparts; Electronic Signatures. This Agreement may be executed in counterparts (including electronic signatures), each of which is deemed an original and all of which constitute one instrument.
X. EXECUTION BLOCK
IN WITNESS WHEREOF, the Parties have executed this Agreement as of the Effective Date.
A. Patient / Representative
| Signature | Printed Name | Date | Capacity (Patient / Authorized Representative) | Relationship (if Representative) |
|---|---|---|---|---|
| [SIGN HERE] | [PRINT] | [DATE] | [SELECT] | [IF APPLICABLE] |
B. Provider
| Signature | Printed Name & Title | Date | License / NPI No. |
|---|---|---|---|
| [SIGN HERE] | [PRINT] | [DATE] | [INSERT] |
[// GUIDANCE: Add notarization or witness lines only if required by facility policy or special circumstances (e.g., experimental treatments).]
SCHEDULE 1 – DISCLOSURE OF MATERIAL RISKS & ALTERNATIVES
[Use plain language and medical terminology understandable to Patient. Tailor to each specific procedure.]
SCHEDULE 2 – NOTICE OF PRIVACY PRACTICES
[Attach most recent HIPAA-compliant notice or incorporate by reference.]
[// GUIDANCE: Conduct annual legal review to ensure ongoing compliance with statutory amendments, including the phased increase to MICRA noneconomic damage caps effective January 1, 2023.]