A review of the global feasibility of medical malpractice insurance: Legal frameworks, economic viability, implementation challenges, and impact on patient safety

Abstract

Medical malpractice insurance (MMI) is a critical determinant of healthcare quality, health partitioners’ behavior, and health system sustainability in many countries. Despite decades of global efforts to reform MMI, evidence of the structure, awareness, implementation, and the impact of its framework remains fragmented. The aim of this review was to synthesize the global literature to map current evidence on the MMI legal framework, its economic viability, barriers to its implementation, and the implications for healthcare delivery and patient safety. A narrative review, informed by a systematic search, was conducted according to PRISMA (Preferred Reporting Items for Systematic Review and Meta-Analyses) 2020 guidelines. Fourteen studies published between 2004 and 2022 were identified from multiple countries, including the United States, Spain, Switzerland, Georgia, Nigeria, and Turkey. Eligible studies included published reviews, empirical studies, and modeling studies related to MMI and its framework. Data were extracted on study characteristics, legal contexts, economic viability assessment, implementation challenges, and patient safety implications. The included studies address a broad range of malpractice-related issues. The evidence revealed substantial variability in how countries regulate and implement MMI, with notable gaps in practitioner knowledge, legal coherence, and affordability. A lack of awareness of health practitioners, regulatory fragmentation, and economically regressive insurance models continue to shape health practitioners’ behavior that could indirectly affect safety and access. The literature lacks robust empirical evaluations that quantify how specific liability reforms translate into improved patient-level outcomes. Future research can prioritize comparative analysis to evaluate policy reforms to create balanced protection for both health practitioners and patients.

Introduction

Medical malpractice continues to shape the performance and stability of health systems worldwide. Rising litigation rates and the growing financial burden of malpractice claims have placed considerable strain on health practitioners, insurers, and policymakers for decades.[1,2] In this context, medical malpractice insurance (MMI) has been used to safeguard both healthcare practitioners and patients. Currently, many health systems worldwide require healthcare practitioners to carry malpractice coverage as a condition of practice, which highlights its importance in promoting continuity of service, patient safety, and system resilience.[3]

MMI influences financial risk, the frequency of reporting incidents, health practitioner behavior, and the practice of defensive medicine.[4] High premiums have been linked to reduced access to specialized services, early retirement of high-risk practitioners, and uneven geographic distribution of physicians, particularly in fields such as obstetrics, surgery, and emergency care.[5,6] In settings where indemnity coverage is insufficient or poorly regulated, malpractice claims can destabilize services and leave both patients (especially those at high risk) and providers without adequate protection.

MMI frameworks differ widely globally. Countries vary in their legal governance of MMI, compensation limits, premium structures, and dispute resolution mechanisms. In low- and middle-income settings, the situation is further complicated by weak regulatory capacity, limited provider awareness, and emerging or underdeveloped insurance markets.[7,8] As a result, patients often lack clear pathways to compensation, and clinicians are not always aware of their legal obligations or professional risks.

The literature examining MMI is extensive but fragmented and spans various disciplines, such as law, health economics, and governance. While some studies have highlighted the potential of indemnity systems to enhance safety in healthcare settings and improve accountability, others have highlighted unintended outcomes such as increased costs and overused defensive practices.[9,10] Hence, policymakers struggle to rely on cohesive evidence when considering reforms or assessing the value of different malpractice frameworks.

Therefore, a unified synthesis of global evidence is needed. This review has two objectives: to identify how MMI is shaped legally and its global economic viability; and to explore the MMI implementation challenges and their impact on patient safety in healthcare settings worldwide.

Materials and Methods

Eligibility criteria

Studies were included if they examined MMI or comparable legal protection frameworks involving healthcare providers, medical professionals, institutions, or legal systems. Studies that reported on outcomes such as economic viability, implementation challenges, and impact on patient safety were also included. Eligible study designs included empirical research (quantitative, qualitative, or mixed-methods primary studies), policy analyses, and systematic reviews published in English, with no year restrictions. Studies were excluded if they did not address MMI, focused on unrelated health policies, lacked relevant outcomes, or were commentaries, editorials, conference abstracts, or opinion pieces without sufficient data. Grey literature, policy reports, and government documents not indexed in the selected databases, institutional guidelines, internal reports, and other nonpeer-reviewed materials were excluded and so were duplicate records and nonretrievable full texts.

Information sources

A detailed investigation was conducted across multiple electronic databases: Scopus, Web of Science, Embase, PubMed, Dimensions, and OpenAlex. Multiple databases were used to access diverse literature in different disciplines to reduce publication and selection bias and confirm the effectiveness of the search strategy.

Search strategy

The narrative review began with a search of Scopus, Web of Science, Embase, PubMed, Dimensions, and OpenAlex databases for data on insurance malpractices. The literature search was conducted with no date restrictions and extended to April 17, 2025. Table 1 shows the search terms used.

Table 1.

Search terms and records

Database	Search strategy	Number of records
Scopus	(TITLE-ABS-KEY(“medical malpractice insurance” OR “professional liability insurance” OR “medical indemnity insurance”)) AND (TITLE-ABS-KEY(“patient safety” OR “healthcare quality” OR “medical error” OR “adverse events” OR “Medical incident” OR “Near miss”))	36
Web of Science	TS=(“medical malpractice insurance” OR “professional liability insurance” OR “medical indemnity insurance”) AND TS=(“patient safety” OR “healthcare quality” OR “medical error” OR “adverse events” OR “medical incident” OR “near miss”)	18
Medline	TS=(“medical malpractice insurance” OR “professional liability insurance” OR “medical indemnity insurance”) AND TS=(“patient safety” OR “healthcare quality” OR “medical error” OR “adverse events” OR “medical incident” OR “near miss”)	18
Embase	(“medical malpractice insurance”/exp OR “medical malpractice insurance”:ti,ab,kw OR “professional liability insurance”:ti,ab,kw OR “medical indemnity insurance”:ti,ab,kw) AND (“patient safety”/exp OR “patient safety”:ti,ab,kw OR “healthcare quality”:ti,ab,kw OR “medical error”:ti,ab,kw OR “adverse events”:ti,ab,kw OR “medical incident”:ti,ab,kw OR “near miss”:ti,ab,kw)	18
PubMed	((“medical malpractice insurance”[Title/Abstract] OR “professional liability insurance”[Title/Abstract] OR “medical indemnity insurance”[Title/Abstract])) AND ((“patient safety”[Title/Abstract] OR “healthcare quality”[Title/Abstract] OR “medical error”[Title/Abstract] OR “adverse events”[Title/Abstract] OR “medical incident”[Title/Abstract] OR “near miss”[Title/Abstract]))	20
Dimensions	(“medical malpractice insurance” OR “professional liability insurance” OR “medical indemnity insurance”) AND (“patient safety” OR “healthcare quality” OR “medical error” OR “adverse events” OR “medical incident” OR “near miss”)	57
OpenAlex	(“medical malpractice insurance” OR “professional liability insurance” OR “medical indemnity insurance”) AND (“patient safety” OR “healthcare quality” OR “medical error” OR “adverse events” OR “medical incident” OR “near miss”)	60

Study selection

This narrative review was informed by a systematic search and conducted in accordance with the Cochrane Handbook for Systematic Reviews of Interventions[11,12] and the PRISMA-2020 guidelines[13,14] and checklist [Figure 1].

Figure 1.

Preferred reporting items for systematic reviews and meta-analyses flow diagram

Table 2 presents the Population, Intervention, Comparison, and Outcome (PICO) analysis in accordance with the study objectives.

Table 2.

Population, Intervention, Comparison, and Outcome Analysis as per the study objectives

PICO	Study objectives
P – Population/Problem	Healthcare providers, institutions, legal systems, and medical professionals are involved in malpractice cases globally
I – Intervention/Exposure	Medical malpractice insurance
C – Comparison (optional)	NA
O – Outcomes	Legal effectiveness, economic viability, implementation challenges, impact on patient safety, and quality of care

NA=Not available, PICO=Population, Intervention, Comparison, and Outcome

Data collection process

Rayyan’s application was first used to screen titles and abstracts and remove duplicates.[15] Subsequently, a single independent reviewer reviewed the papers obtained after the Rayyan’s application screening to determine whether the articles fulfilled the inclusion criteria. Any issues were resolved by discussion with a second reviewer.

A comprehensive data extraction was conducted using Excel tables to extract all relevant information from the studies included. The extracted data included basic information (authors, year of publication, study title, and study design) and the population according to the PICO sections given in Table 2.

Two autonomous reviewers conducted the data extraction, and any disagreements were resolved by discussion and/or third-party negotiation.

Quality assessment of included studies

Methodological rigor in this review was achieved with the critical appraisal of the methodological validity of the studies included by two independent reviewers using two widely recognized and cited tools in health research studies: The Mixed Methods Appraisal Tool (MMAT),[16] and the Joanna Briggs Institute (JBI) Critical Appraisal Tool.[17] The reason for this was that the review included heterogeneous studies (i.e. empirical and non-empirical studies), which required the use of appraisal tools tailored to different study designs.

The MMAT, designed to evaluate methodological quality across empirical studies, including quantitative, qualitative, and mixed-methods studies, employs systematic criteria and utilizes category-specific items to facilitate consistent evaluation of studies.[18] The tool is methodologically accepted, with expert-validated content. Therefore, many health-related systematic review studies have utilized this quality appraisal tool.[19,20]

The JBI tool supports researchers in assessing the quality of non-empirical studies, such as narrative review studies, expert opinion published papers, and policy analyses.[17] It emphasizes clarity of context, coherence, and credibility of sources to ensure transparent appraisal of nonempirical evidence that contributes to healthcare studies.[21]

The quality appraisal findings of the empirical studies included in this review, as shown in Tables 3 and 4, revealed that these studies were of moderate to high quality, with strengths in sampling relevance, measurement appropriateness, and analytical rigor. Partial limitations were noted in the sample representatives and nonresponse bias, especially in the Ajemunigbohun et al.’s study.[7] Page et al.’s study has limitations too because of its reliance on self-reported surveys,[13] but McLennan et al., demonstrated high methodological quality, with coherent data collection and interpretation.[22]

Table 3.

Quality assessment of empirical papers using mixed methods appraisal tool (Quantitative papers)

MMAT Question (Quantitative Descriptive)	Ajemunigbohun[7]	Page et al.[13]	Tsintsadze and Gogoberidze[32]	Baker and Charney[33]
Screening Questions
Are there clear research questions?	Yes	Yes	Yes	Yes
Do the collected data allow addressing research questions?	Yes	Yes	Yes	Yes
Quantitative descriptive criteria
Is the sampling strategy relevant to address the research question?	Yes	Yes	Yes	Yes
Is the sample representative of the target population?	Partial	Partial	Partial	Yes
Are the measurements appropriate (e.g., valid and reliable)?	Yes	Yes	Yes	Yes
Is the risk of nonresponse bias low?	Partial	Partial	Partial	Partial
Is the statistical analysis appropriate to answer the research question?	Yes	Yes	Yes	Yes
Strengths	Survey conducted among medical practitioners, relevant to the research question	National survey; relevant to the midwifery liability context	Algorithm clearly described; appropriate data analysis Real-world error-reporting data; comprehensive descriptive analysis
Limitations	Convenience or partial sampling; potential nonresponse bias; self-reported data	Partial sampling; self-reported survey; descriptive only	Model assumptions may limit generalizability; not real-world tested	Nonresponse or missing data not fully addressed
Overall quality	Moderate	Moderate	Moderate	Moderate-High

MMAT=Mixed Methods Appraisal Tool

Table 4.

Quality assessment of empirical paper using mixed methods appraisal tool (Qualitative paper)

MMAT Question (Qualitative)	McLennan et al.[22]
Screening questions
Are there clear research questions?	Yes
Do the collected data allow addressing research questions?	Yes
Qualitative criteria
Is the qualitative approach appropriate to answer the research question?	Yes
Are the data collection methods adequate to address the research question?	Yes
Are the findings derived appropriately from the data?	Yes
Is the interpretation of results substantiated by the data?	Yes
Is there coherence between data sources, collection, analysis, and interpretation?	Yes
Strengths	Well-conducted interviews provide in-depth insight into error disclosure and professional liability practices
Limitations	Limited sample size; may not be generalizable beyond the participants; qualitative only
Overall quality	High

MMAT=Mixed methods appraisal tool

The quality appraisal findings of the nonempirical narrative studies included in this review, as shown in Table 5, consistently displayed credible sources, logical synthesis, and coherent conclusions. However, limitations included a lack of systematic search and reliance on conceptual discussion. Several studies did not report a systematic search strategy to identify the evidence upon which their conclusions were based.[23,24,25,26,27,28,29] These studies relied on descriptive explanation and policy critique rather than the synthesis of structured evidence. Despite their methodological limitations, these narrative policy-oriented papers provided in-depth conceptual analyses of policies related to medical liability insurance and its impact on patient safety based on expert insights from diverse contexts.

Table 5.

Quality assessment of nonempirical papers

Study	Credible source?	Context explained?	Logical sequence?	Does the reader reach similar conclusions?	Conclusions flow?	Is it narrative?	Strengths	Limitations	Overall quality
Amon and Winn[23]	Yes	Partial	Yes	Yes	Yes	Yes	Combines contextual and historical insights	Mixed empirical and narrative; review not systematic	Moderate
Civaner[24]	Yes	Partial	Yes	Partial	Yes	N/A	Ethical insight, clear argument	Mostly opinion-based, with limited literature support	Moderate
Lindenfeld[25]	Yes	Yes	Yes	Yes	Yes	Yes	Strong conceptual critique, clear policy discussion	No systematic literature search	Moderate-High
Sage[26]	Yes	Yes	Yes	Yes	Yes	Yes	Historical perspective, organized discussion	Narrative only, not evidence-based	Moderate
Weinstein[27]	Yes	Yes	Yes	Yes	Yes	Yes	Clear argument, credible sources, logical synthesis	No systematic search, no empirical	High
Dolz-Güerri[28]	Yes	Partial	Yes	Yes	Yes	Yes	Synthesizes clinical safety and liability trends	Narrative portion not systematic; mixed empirical/narrative	Moderate
Peterson[29]	Yes	Partial	Yes	Partial	Yes	N/A	Conceptual clarity, policy relevance	Opinion-based, not evidence-driven	Moderate
Webel et al.[30]	Yes	Yes	Yes	Yes	Yes	Yes	Well-organized legislative review, credible sources	Descriptive only, no critical appraisal of legislation	Moderate-High
Ngo et al.[31]	Yes	Yes	Yes	Yes	Yes	Yes	Explains the complex legal-educational intersection	No empirical data; narrative only	Moderate

N/A=Not available

Data synthesis

The data were synthesized using a narrative, thematic approach with no statistical or quantitative synthesis because, as mentioned earlier, the studies included varied in their methodologies, and were conducted in different contexts. Thus, a meta-analysis could not be undertaken. Evidence was grouped into predefined themes tailored to the research objectives to identify consistent patterns in how MMI influenced healthcare practice, patient safety, and insurance dynamics globally.

Results

Data analysis was conducted in three main phases: Organizing studies by thematic concepts; identifying patterns, convergence, and divergence; and integrating findings across legal, economic, and patient safety dimensions.

During phase 1, four overarching themes emerged: Legal frameworks of MMI; Economic viability and sustainability; implementation challenges; and impact on patient safety and quality of care. Within each theme, studies were further categorized by type (i.e. empirical quantitative, empirical qualitative, policy/legal analysis, or narrative review) to facilitate comparability across the study findings, as shown in Table 6.

Table 6.

The narrative review data synthesis

Author (year)	Legal framework summary	Economic viability assessment	Implementation management	Impact on patient safety
Ajemunibohun[7]	HPII is mandatory in Nigeria for medical practitioners and health workers to cover losses arising from professional negligence	HPII is a crucial risk management and financial instrument for managing medical negligence and claims costs. HPII helps professionals limit the financial consequences of legal action	The study recommends the NMA which implements HPII to improve awareness of this law among health professionals	Medical errors are serious public health problems that cause a catastrophic threat to patient safety. Low awareness and poor adoption of HPII leave medical professionals vulnerable to liability risks
Page et al.[13]	Liability requirements vary by state; some states require midwives to carry malpractice insurance while others do not, leading to inconsistent legal protection and practice restrictions. Midwives were found to have a high incidence of litigation risk compared to other nurses	MMI is costly and hard to obtain. More than half of the participants do not know the premium. Cost/availability affected practice decisions (e.g., quicker consultation/referral), and lack of knowledge about premium costs discouraged private practice	Recommends continued education on PLI types, policy terms, and affordability. Advocates for improved peer support resources and training for colleagues coping with litigation. Proposes adding a core competency addressing response to adverse events and malpractice liability	Fear of liability reduces midwife availability, causes defensive practice changes, and avoiding high-risk patients, stopping VBAC. This caused indirect negative impact on patient outcomes
McLennan et al.[22]	Professional liability insurance is mandatory. There is no legal obligation for physicians to disclose errors to patients – disclosure is considered an ethical duty rather than a legal requirement	This model is economically efficient in containing costs, but not optimal for promoting full transparency or learning from mistakes, due to doctor’s fear to disclose mistakes	Some large governmental hospitals are adopting self-insurance model to control how claims are managed and settled. While private health organizations rely on commercial insurance “insurance companies” to settle liability claims	Type of insurance influences how openly doctors disclose medical errors In self-insured hospitals, doctors feared internal disciplinary action or losing their employer’s trust, while in commercially insured systems, they worried about insurer approval and higher premiums
Amon and Winn[23]	MCare Act of 2002 mandated a confidential, mandatory reporting system requiring a letter to patients who experienced a serious event to encourage honest reporting	The Authority was established as a solution to rising medical malpractice insurance costs. By promoting transparent communication and systematic review of errors, the program aimed to support cost reduction. The use of large database enables identifying trends, helping hospitals to target safety risks to reduce errors and its associated costs	Physicians were forced to restrict services. Advocacy groups must critically review medical malpractice insurance data and obtain their own data to counter incomplete or misleading reports. Public support, less extreme judicial (court) decisions, and fairer laws are also required to stabilize the system	Life-saving Specialists were less willing to care for emergency/indigent patients due to liability exposure. This causes risks of access as well as patient safety
Civaner[24]	Turkey adopts an individual-focused approach defining malpractice as intentional fault. It is recommended adopting a system-focused approach where harms are compensated regardless of fault (error or complication) through a government-managed fund	High compensations and rising insurance premiums negatively affect service. Defensive medicine (avoiding high-risk patients, ordering unnecessary tests) increases healthcare costs. Private insurance fails to focus on reducing risks/errors	Requires adoption of a system-focused approach (retrospective analysis). Encouraging error reporting by ensuring confidentiality (like the US Patient Safety Quality Improvement Act) encouraging learning instead of blame	Blame culture leads to errors being repeated. Defensive medicine increases preventable harms. System-focused approach ensures better reporting, and thus more errors can be corrected
Lindenfeld[25]	The study critiques noneconomic damage caps. The study argues that such limits weaken the deterrent effect of malpractice law	Statistical data suggest noneconomic damage caps are not economically viable	The author suggested practical solutions such as requiring expert review before a case goes to court, encouraging doctors and patients to talk openly and settle early, linking insurance costs to each doctor’s safety record, and focusing more on preventing medical mistakes in the first place by applying safety measures	Noneconomic damage caps are likely to increase malpractice by removing the threat of financial costs on the health organizations and doctors
Sage[26]	The Tort Liability Model is a traditional court-based system where patients sue doctors for negligence based on individual blame and compensation through lawsuits	The structure of the Tort liability model is unstable and increasingly unaffordable because of the premiums increase via the insurance companies, meaning the current model isn’t economically sustainable without proper reform	The malpractice system was managed mainly by private insurers who handled lawsuits and set premiums (fees doctors pay) based on specialty, claim history, and market conditions, while the government only regulated from the outside. There was no central coordination with hospitals or safety programs – each part (law, insurance, healthcare) worked separately	Poor insurance structures delay resolution of claims and hinder learning from previous errors, which negatively affect patient-safety
Weinstein[27]	Traditional tort reform (caps on noneconomic damages/contingency fees) is ineffective as a “back-end approach.” because it fails to identify the root causes of the malpractice issue	The malpractice crisis is defined by the rising cost of liability insurance, which physicians can no longer easily afford. True saving can come from preventing errors and stabilizing risks overtime	The study calls for shifting from reactive risk-management (waiting for claims) to proactive safety-management	Transparency is necessary to prevent errors. The use of national electronic medical records, rapid response teams, full disclosure of errors, teamwork training, and fair expert review of claims will enhance patient safety
Dolz-Güerri et al.[28]	Medical action must be performed and requires ICDs for high-risk procedures. Responsibility rates are higher for elective/noncurative medicine (e.g., refractive surgery). Claims arising from absent or deficient ICDs result in financial compensation	Ophthalmology is a “risk specialty” with a high frequency of claims and a high risk of financial compensation. The fear of litigation may lead to defensive medicine	Adequate training in medical-legal aspects is essential for specialists to avoid defensive medicine. Implementing safety programs by utilizing scientific societies developing tools (such as checklists, protocols, ICDs) is important for potentially avoidable errors	Claims analysis is a useful tool to ensure clinical actions fulfill the standards of professional practices “Lex artis”
Peterson[29]	Commentary/Legal discussion examining the laws that allow hospitals to add malpractice surcharge (extra fees/penalties) to physicians with claims history; raises concerns about fairness, legal challenges, and accountability	Surcharges may temporarily recover insurance costs but can push physicians to relocate, retire early, or limit services, which may create long-term economic and workforce challenge	Physicians adopted surcharges to cover rising costs. This requires monitoring claims history, assigning penalties, and managing appeals	The malpractice crisis threatens access to needed medical attention, forcing doctors to use defensive medicine, avoiding high-risk patients. The surcharge can weaken the trust between physicians and patients
Webel et al.[30]	The study reviewed proposed federal tort reform (HEALTH Act) to change how medical malpractice cases are handled. These proposals included limiting patients’ monetary benefits in lawsuits, applying maximum caps on lawyer fees, and encouraging mediation rather than reaching courts	Reform aims to decrease malpractice costs and insurance premiums, but national savings are uncertain and debated; potential cost reduction varies widely by U.S. states	It suggests new claim processing rules: Health Courts (using trained judges/experts) and Early Disclosure protocols (disclosure, apology, compensation offer)	Concern about claims affects provider decisions via defensive medicine. Reforms might reduce this risk
Ngo et al.[31]	Residents are held to the same standard of care as attending physicians, but liability usually falls on supervising physicians and institutions	Malpractice claims involving residents increase legal and insurance costs for teaching hospitals. Better supervision and documentation may reduce avoidable costs	Sponsoring institutions must provide continuing medical education, risk management programs, and protection against the medicolegal system	Policies require clear supervision, documentation, and informed consent and clarity of responsibilities to improve patient safety
Tsintsadze and Gogoberidze[32]	Georgia’s current punitive measures are does not enforce liability insurance for high-risk professions. Current penalties for improper medical practice are limited, often restricted to minor actions (e.g., written warning for improper medical practice)	Risk-based tariffs calculation should be based on the principle of the insured’s “fit to pay” while ensuring insurer stability	The study proposed an algorithm for calculating fair insurance tariffs based on professionalism levels (merit-based pricing). It also recommends the introduction of compulsory insurance for high-risk organizations	Better risk-pricing may encourage safer practices
Baker and Charney[33]	MCare Act of 2002 mandated a confidential, mandatory reporting system requiring a letter to patients who experienced a serious event to encourage honest reporting	The Authority was established as a solution to rising medical malpractice insurance costs. By promoting transparent communication and systematic review of errors, the program aimed to support cost reduction	Implementation involved a confidential, mandatory statewide reporting system. Adopted a systems approach to safety and provides advice, educational tools, and on-site training via PSLs	Shared learning leads to proactive risk reduction, but safety improvement depends on how hospitals acted on the data

HPII=Healthcare Professional Indemnity Insurance, NMA=Nigerian Medical Association, MMI=Medical malpractice insurance, PLI=Professional Liability Insurance, VBAC=Vaginal birth after cesarean, MCare=Medical care availability and reduction of error, ICDs=Informed consent documents, PSLs=Patient safety liaisons

In phase 2, a comparative analysis was conducted to identify Convergent findings (e.g. consistent evidence across study regions and types), divergent findings (e.g. contradictory findings in economic feasibility or the impact of defensive medicine), and context-specific differences (e.g. countries with mandatory MMI, and self-insurance vs. commercial insurance).

In phase 3, interpretation of how MMI functions as a multidimensional system was implemented. This approach was conducted to provide a cross-theme narrative explaining how MMI influences healthcare systems on macro-level (e.g. policy and economics) and micro-level (e.g. healthcare professionals’ behavior and patient safety) outcomes globally.

Table 7 illustrates the main findings for the studies included. The findings were structured around the themes that emerged in phase 1 of data synthesis.

Table 7.

Summary of main findings for the included studies

Author	Country	Study type	Methods used	Key findings
Ajemunibohun[7]	Nigeria	Empirical quantitative study (survey-based)	Descriptive study using a survey approach with a purposive sampling technique	The level of awareness and adoption of HPII is low among operators of private health facilities in Lagos State, Nigeria. Medical malpractice insurance is essential for protecting patients from the repercussions of medical errors
Page et al.[13]	United States	Empirical quantitative study (survey-based)	National online survey of CNMs and CMs about liability insurance, claims, costs, and practice impact	Lack of affordable and consistent liability insurance causes significant financial and practice barriers for midwives, affecting workforce availability more than improving safety
McLennan et al.[22]	Switzerland	Empirical qualitative study (Interviews)	Qualitative study using semi-structured interviews with 23 key medicolegal stakeholders (law professors, hospital quality heads, insurer reps, etc.). Data analyzed using conventional content analysis	A fundamental conflict exists between liability insurance requirements and the ethical/legal obligation for open disclosure after medical errors in Swiss hospitals. Legal fears are the most pervasive barrier to disclosure
Amon and Winn[23]	United States	Comparative study	Data analysis from multiple physician surveys, the MDI reports, and court records	The Missouri PLI crisis (2001–2002) was driven by massive premium increases and a critical court ruling, which caused legal and insurance instability
Civaner[24]	Turkey	Narrative review	Conceptual review comparing individual-focused (“blame culture”) versus system-focused (“cheese theory”) approaches	The individual-focused “blame culture” approach adopted in Turkey is ineffective and harmful. Compulsory PLI and healthcare privatization policies are predicted to worsen negative results
Lindenfeld[25]	United States	Policy-oriented review	Empirical and policy reports, peer-reviewed literature, economic analysis, and court cases	Noneconomic damage caps are an undesirable approach because they are statistically ineffective, threaten patient safety by reducing deterrence, and disproportionately harm vulnerable groups (women, children, the elderly). Multifaceted alternatives are necessary
Sage[26]	United States	Policy-oriented review	Policy analysis review addressing how liability insurance markets evolved in the USA and their role in the malpractice system	Insurer withdrawal, premium spikes, and coverage instability are what drive the “malpractice crisis”
Weinstein[27]	United States	Narrative review	Review/Discussion based on published literature and official reports	The pursuit of tort reform over 30 years has had minimal results and fails to address preventable medical errors. The solution must address patient safety and medical error directly. Full disclosure of errors is the proper approach and has not been shown to increase legal risk
Dolz-Güerri et al.[28]	Spain	Narrative analysis or empirical quantitative study	Descriptive review of published research with a preliminary descriptive analysis of claims submitted to the CMSC	Ophthalmology is the 4th specialty in frequency of claims in Spain, with a high compensation rate. Most frequent claims relate to surgical procedures (cataract, palpebral, refractive) and defects in patient information
Peterson[29]	United States	Policy-oriented review	Review of malpractice surcharge policies, legal context, and implications	Malpractice surcharges or donation requests are problematic because they direct the physician’s decisions in their own self-interest rather than in the patient’s best interest
Webel et al.[30]	United States	Policy-oriented review	Review of federal bills, government reports, and congressional discussions	Many reforms aim to reduce legal and insurance costs, but evidence is mixed on whether they are lower overall healthcare spending or improve care
Ngo et al.[31]	United States	Narrative review	Review/Legal discussion drawing on malpractice laws, court cases, and national data (National Practitioner Data Bank) regarding policies related to residents and teaching hospital	Clear supervision, documentation, and defined roles reduce both malpractice risk and patient harm during residency training
Tsintsadze and Gogoberidze[32]	Georgia	Empirical – quantitative study (risk modelling, algorithmic/actuarial analysis)	Mathematical risk modeling by developing a simple algorithm for PLI tariff calculation. Uses Druzhilov’s professionalism system for risk coefficient calculation	PLI premiums should incorporate merit-based pricing rather than fixed pricing for all professionals
Baker and Charney[33]	United States	Empirical – quantitative study	Analysis of statewide event-reporting data, safety reports, and system performance	PPSA uses a mandatory, confidential, system-focused approach to report errors (including near misses), enabling shared learning and significant process changes. Real safety improvements depended on how hospitals actively use the reports to change practices

HPII=Healthcare Professional Indemnity Insurance, CNMs=Certified Nurse-Midwives, CMs=Certified Midwives, MDI=Missouri Department of Insurance, PLI=Professional Liability Insurance, CMSC=Council of the Medical Societies of Catalonia, PPSA=Personal Property Securities Act

Legal frameworks of medical malpractice insurance

How legal frameworks define MMI in the included studies vary, ranging from mandatory MMI systems to fault-based tort models. Several studies highlighted mandatory MMI as “legal safeguard,” while others criticized the tort-based system, a traditional court-based system in which patients sued doctors for negligence based on individual blame and compensation obtained through lawsuits were reactive, fragmented, and punitive.

Four studies examined how MMI frameworks are shaped legally in the United States and their impact on the litigation process by analyzing the tort-based system and its reform.[26,27,30,31] They highlighted several challenges, most importantly, those related to the fragmented legal system and the lack of standardized procedures for error disclosure.

For example, the Weinstein study argued that tort reform, particularly, measures such issues as caps on noneconomic damages and restrictions on contingency fees, offers only a superficial, “back-end” remedy to the malpractice crisis.[27] Such reforms do not adequately address the systemic drivers of medical errors and therefore, fail to produce meaningful or sustainable improvements in patient safety or liability outcomes.

The Sage study explained that in the United States, malpractice lawsuits are primarily managed by private insurers who set premiums based on specialty and claim history.[26] Government agencies regulate from the outside with limited centralized oversight rather than the control of market prices. They only review filings, ensure regulatory compliance, and prevent unreasonable rate increases.

Ngo et al., highlighted professional liability policies related to residents at teaching hospitals.[31] The study stated that residents are held to the same standard of care as attending physicians, but liability usually falls on supervising physicians and institutions. The study highlighted the importance of policy that is clear on supervision, documentation, and informed consent that declares trainees’ involvement.

The findings of an empirical study by McLennan et al., on the views of medicolegal stakeholders (i.e. law professors, hospital quality heads, and insurer representatives) regarding legal obligations and ethical responsibilities related to error disclosure,[22] illustrated a gap between insurance-driven legal frameworks and clinical transparency. They highlighted that although professional liability insurance is mandatory, physicians are not legally obligated to disclose errors to patients. This is an ethical duty rather than a legal requirement.

Moreover, the study by Webel et al., reviewed the proposed federal tort reform (i.e. the HEALTH Act) to examine how medical malpractice cases are handled.[30] It proposed that it was important to make such changes to the current practice as limiting patients’ monetary benefits in lawsuits, applying caps on lawyer fees, and encouraging mediation rather than litigation. These recommendations were proposed to ensure better economic viability, quality and patient safety in healthcare delivery.

Economic viability and sustainability

MMI is a tool that protects healthcare workers from high financial costs from medical negligence claims.[7] Since medical errors can impose a severe and permanent financial burden on patients, families, and society, MMI helps practitioners to manage this risk by covering legal expenses and compensation so that healthcare providers do not have to carry the full economic consequences of a lawsuit.

However, four of the included studies addressed economic challenges in relation to MMI. For instance, two studies criticized existing malpractice insurance costs since premium surges and limited insurance capacity affect access to care and, in turn, threaten system sustainability.[23,25] Another reported that ophthalmology is a “risk specialty” with a high frequency of claims and a high risk of monetary compensation.[28] Thus, the fear of litigation could lead to defensive medical practices that can harm professional judgment and increase system costs. Another study reported that high compensation and rising insurance premiums negatively affect the health services.[24] Defensive medicine (e.g. avoiding high-risk patients and ordering unnecessary tests and procedures) increases healthcare costs.[24]

Lindenfeld’s critiqued noneconomic damage caps (i.e. putting a legal cap on how much money patients could receive for pain, suffering, or emotional harm after medical errors).[25] The study argued that such limits deteriorate the effect of malpractice law because doctors would feel less pressured to avoid mistakes or improve safety practices, and the statistical data suggest that noneconomic damage caps are not economically viable[32]

Baker and Charney provided empirical evidence on cost containment through a mandatory reporting system linked to insurance reforms.[33] They emphasized that mandatory reporting and nonpunitive, confidential systems can promote a safety culture that mitigates defensive medicine. This approach can encourage learning from errors and improve patient safety and controlling costs.

Implementation challenges

Several empirical studies have revealed significant barriers to effective MMI implementation, including low awareness of MMI, poor adoption of indemnity insurance, and inconsistent institutional incentives that hinder transparency and disclosure.[7,22] Another described clinical specialty-specific challenges, such as the legal risks in ophthalmology that affect healthcare professionals’ behavior in clinical encounter.[28]

There is a clear contrast between what can be called “decentralized MMI-driven management”[22,26] and “centrally coordinated patient safety systems,”[23,33] that are implemented with more structured reporting, expert reviews, and learning mechanisms, demonstrating greater integration of the legal, insurance, and patient safety domains.

Impact of patient safety and quality of care

The reviewed literature suggests a complex relationship between MMI and patient safety outcomes. For instance, two studies emphasized that MMI can promote proactive risk management if integrated with transparent reporting systems and safety culture reforms.[27,33] Conversely, two other studies highlighted the fact that punitive legal environments and surcharge policies may increase defensive medicine in which healthcare professionals alter clinical behavior to avoid litigation rather than provide care in the patient’s best interest.[25,29] Dolz-Güerri et al., stated that fear of claims leads healthcare professionals to conduct unnecessary tests or treatments, which increase system costs and potentially harm patients.[28] Therefore, defensive medicine may unintentionally deteriorate efficient care. Hence, Ngo et al., highlighted the importance of clear supervision and documentation in reducing malpractice risks during medical education.[31]

Discussion

This review shows that MMI operates within a complex environment shaped by legal structures, financial pressures, institutional culture, and professional behavior. Although MMI is intended to protect both patients and health practitioners, the evidence suggests that its effectiveness depends less on the insurance product itself and more on the systems and contexts in which it operates. A consistent pattern emerges across studies that reforms that focus solely on litigation, compensation limits, or premium regulation tend to offer limited value because they address outcomes after harm has already been done rather than the conditions that made errors more likely to occur in the first place.

The studies that examine legal frameworks highlight how reliance on traditional court litigation and fragmented supervision creates inconsistencies in accountability and weak support for transparency. Evidence from the United States, for example, illustrates how traditional tort reforms (e.g. caps on noneconomic damages) have not significantly reduced errors or improved patient safety.[27,30] Additional findings reveal gaps between ethical expectations and legal requirements, particularly with regard to the disclosure of medical errors, supervision, and documentation.[22,31] These discrepancies support the idea that a purely legalistic response to malpractice overlooks the broader system-level contributors to risk. From a policy perspective, these findings suggest that malpractice reforms may benefit from moving beyond tort-based mechanisms toward national-level standards that promote consistent supervision, disclosure, and system-level learning to ensure safer clinical practice in all healthcare settings.

Economic considerations further complicate the functioning of MMI. Several studies describe the rising cost of premiums, limited insurance capacity, and specialty-specific vulnerabilities that encourage defensive medicine. These behaviors increase costs without improving outcomes.[24,28] Conversely, evidence also shows that when MMI is integrated with learning-oriented reporting systems, the result is that organizations can shift from a punitive culture to a preventative one.[33] Thus, the economic sustainability of malpractice systems is more likely to be achieved by reducing preventable harm than by limiting compensation. In practice, integrating MMI with learning-oriented reporting system may reduce defensive medicine and enhance efficiency and patient safety in care delivery.

Implementation challenges in the literature reveal gaps in awareness, institutional incentives, and professional culture. Low uptake of indemnity insurance in certain settings, unclear expectations in supervision, and the fear of legal consequences collectively hinder the ability of MMI to function as intended. These barriers indicate that mandates alone are insufficient. Therefore, effective implementation requires investment in professional education, leadership engagement, and institutional cultures that support transparency and continuous improvement instead of punitive, blame-driven approaches.

Overall, the evidence reviewed suggests that the impact of MMI is shaped less by the insurance mechanism itself and more by how it is embedded within legal, organizational, and professional systems. Approaches that prioritize learning, transparency, and system-level accountability appear more likely to support patient safety and sustainable practice than reforms focused solely on post-harm compensation. These findings highlight the importance of aligning malpractice frameworks with broader governance and quality-improvement strategies to ensure that both protection and professional accountability are meaningfully achieved.

Limitations

The inclusion of empirical research articles and review papers limited this study. The exclusion of grey literature does limit the comprehensiveness of the findings and introduces publication bias. Although a systematic search strategy was implemented, the study is still subject to selection bias, especially in relation to its inclusion criteria, and interpretive bias in the synthesis of findings. Future reviews could benefit from incorporating grey literature to provide a more complete understanding of this issue.

Implications for practice and research

Findings suggest that meaningful malpractice reform needs a shift from punitive, litigation-driven approaches toward models that support learning from mistakes and system-level improvement. Policymakers must consider developing nation-wide standards of supervision, documentation, and disclosure to reduce inconsistencies and strengthen accountability in malpractice. It is crucial to align insurance systems with patient-safety strategies to proactively address medical errors. Moreover, improving healthcare providers’ awareness of indemnity obligations, risk management principles, and communication expectations can help bridge the gap between legal requirements and clinical practice, particularly in high-risk specialties where defensive medicine is more prevalent.

Future research can explore how different malpractice structures function in diverse health systems. Longitudinal studies are needed to assess how specific legal reforms, reporting structures, and insurance models influence the clinician’s behavior, defensive medicine, and patient outcomes over time. Patient perceptions are also essential in designing malpractice systems that balance the provision of protection with fair compensation.

Conclusion

In summary, the impact of MMI cannot be understood solely through legal reforms or economic mechanisms. Its value depends on the degree to which healthcare systems integrate insurance structures with supportive cultures, clear clinical expectations, and robust reporting practices. Reforms that focus narrowly on litigation or financial limits are unlikely to yield meaningful improvements in patient safety unless they are tied to broader organizational efforts that reduce preventable harm, enhance supervision, and strengthen accountability.

Conflicts of interest

There are no conflicts of interest.

Funding Statement

Nil.