Introduction

Contemporary medical practice constitutes a paradigmatic field of exposure to risks relevant to legal interests of maximum protection, because the production of adverse results can coexist clearly with technically correct and legally permitted actions (Domínguez, 2023, p. 109); precisely for this reason, medical criminal liability (Etcheberry, 1986, p. 279; Vargas, 2010, p. 104) announces the advent of a specific dogmatic difficulty, consisting of preventing imputation from shifting toward a logic of reproach for the result, which is incompatible with the structural principles of Criminal Law, and which, in turn, must maintain the capacity for attribution in the face of serious breaches of the duty of care that generate legally disapproved risks (Pérez, 2009, p. 1398).

Within this terrain, the challenge does not lie in describing that the exercise of medicine involves dangers, but in constructing sufficiently precise normative criteria to distinguish between damages attributable to the inherent and socially accepted risk of medical activity (Bracho, 2025b, p. 59; Hernández & Cayón, 2023, p. 104) and damages that, by deriving from a prohibited risk, enable criminal imputation (Jakobs, 2004, p. 504).

The central problem is situated, therefore, at the dogmatic boundary between permitted risk and objective imputation; given that permitted risk (Aedo, 2020, p. 123; Gil, 2025, p. 138; Porfírio, 2022, p. 208; Reyes, 2015, p. 142) fulfills a limiting function, which excludes reproach when the activity is framed within normatively tolerated margins, even if these produce harmful consequences.

For its part, objective imputation (Balla, 2024, p. 190) operates as a mechanism for the normative attribution of the result in which it is required that the conduct has created an unpermitted risk and that said risk has been realized in the result and that such a result is within the scope of protection of the infringed norm.

In such a way that, together, both categories allow for shifting the focus from merely factual causality toward the normative judgment of criminal relevance of the conduct (García, 2010, p. 18); this avoids, therefore, the expansion of Criminal Law toward objective liability (Llovet, 1993, p. 320; Peno & Bogucki, 2021, p. 570) as well as the reduction of the analysis to a mere technical or retrospective verification of the error.

With reference to the field of malpractice (Mišić & Vukušić, 2020, p. 780), this dogmatic structure requires completion through an ideal standard for specifying the objective duty of care (Montealegre, 1987, pp. 282–284), since at that level, lex artis functions as a technical-normative parameter for determining what conduct was required in the specific case.

However, from the beginning, it is convenient to set a decisive premise for the dogmatic coherence of the analysis, because lex artis does not in itself constitute a criterion for criminal imputation, but rather a parameter for assessing the care due; so its infringement only acquires legal-criminal relevance when it is integrated into a complete judgment of objective imputation, the deployment of which presupposes, on a logical level, the prior verification of factual causality (Puppe, 2001, pp. 57-60).

In other words, deviation from the professional standard is not automatically equivalent to the criminal attribution of the result; although it does constitute a piece of data of normative significance that must be assessed in light of the requirements for the creation and realization of a legally disapproved risk. To avoid retrospective distortions, the professional standard must be understood in an ex ante and contextual key (Reyes-Romero, 2024, pp. 145-146), not as a tool for reconstruction based on the outcome, but as a kind of parameter of exigibility valued in accordance with the knowledge, means, and conditions of action available at that moment. This perspective is especially relevant in emergency clinical scenarios, given the uncertainty and limitation of resources inherent in medical practice.

In the same sense, lex artis as a cognitive construction operates as a technical standard for assessing care, and not as an autonomous source of the criminal judgment of typicity or wrongfulness, which remains governed by dogmatic categories of imputation. In this framework, the article is guided by the following dogmatic question: Under what conditions does a deviation from the objective duty of care assessed on the basis of lex artis configure an objectively imputable unpermitted risk to the health professional, and under what conditions should the adverse result remain within the scope of permitted risk inherent in medical activity?

The hypothesis guiding this research is not limited to maintaining that criminal imputation for medical malpractice requires the cumulative concurrence of certain dogmatic filters, an assertion that on its own does not allow for capturing the specificity of the analyzed problem.

What is proposed is the delimitation between permitted risk and criminally relevant risk, which requires a sequential-cumulative rule of decision in which lex artis operates exclusively as an ex ante parameter for specifying the objective duty of care and not as an autonomous criterion for imputation.

Under this premise, the objective imputation of the result can only be affirmed when the deviation from the professional standard translates into the creation or increase of a legally disapproved risk, that risk is effectively realized in the result, which belongs to the scope of protection of the infringed norm of care.

Now, the decisive point lies in specifying when the transition from permitted risk to disapproved risk occurs; to that end, the rule relies on contextual criteria of ex ante control that allow for normatively specifying the judgment on the disapproval of the risk, with particular attention to scenarios of coordinated healthcare action, in which the principle of reliance acquires relevance as delimited criteria.

In this way, the proposed sequence fulfills a function of dogmatic closure, in that it prevents the advent of imputative automatisms, while at the same time it neutralizes retrospective bias and prevents the mere verification of a technical infraction from replacing the true criminal judgment of attribution. When the result constitutes the realization of a risk that remains within the margins tolerated by the legal system, criminal imputation must be excluded, even when the outcome is serious or generates intense commotion.

From this perspective, the articulation of categories is proposed according to a reconstructive logic whose sequence admits neither inversion nor omission of links, ideal for ordering the transition between permitted risk and unpermitted risk in a field particularly exposed to ex post bias such as medical practice.

Consequently, the proposal seeks to avoid two deviations; the first is reducing objective imputation to the sole formal verification of a causal connection (Peláez, 2018, pp. 315-317); the second consists of improperly converting lex artis into a substitute for legal-criminal judgment. On that basis, the general objective is to present this sequential and cumulative rule as a useful dogmatic closure criterion to delimit the boundary between permitted risk and unpermitted risk in cases of medical malpractice. For this purpose, lex artis is integrated as a parameter for specifying the objective duty of care, as are the normative requirements that structure the objective imputation of the result.

In concrete terms, it seeks to specify the scope of permitted risk as a normative limit against imputations built solely from the harmful result; to delimit the role of lex artis as an instrument for specifying the objective duty of care (Rueda, 2025, p. 190), recognizing its importance but without attributing an self-sufficient value to it; finally, to link the infraction of the care due with the creation of the unpermitted risk, its realization in the result, and the belonging of the latter to the scope of protection of the norm, within a verifiable analytical sequence.

With the aim of avoiding frequent misunderstandings, it is warned that this article adopts a strict conceptual delimitation corresponding to medical malpractice. In this sense, for criminal purposes, it is not understood as any unfavorable outcome or any technical divergence, but as professional conduct that, normatively evaluated, infringes the objective duty of care and is integrated into a judgment of objective imputation of the result.

Due to this, the analysis is focused on criminal liability derived from reckless conduct, both by action and by omission; thus, within the contexts of duties of control linked to the performance of medical acts (Porfírio, 2022, p. 208), leaving aside its object consisting of the systemic examination of intentional cases (Ossandón, 2022, p. 528; Rusca, 2025, p. 133), as well as autonomous developments of civil (Riveros et al., 2019, p. 1578), administrative, disciplinary, or professional ethical liability; as a consequence, such precision is unavoidable to prevent the conceptual category of malpractice from operating as an undifferentiated label and improperly replacing the dogmatic analysis required by Criminal Law.

Finally, these elements are integrated into a systematic scheme for the attribution of the result, developed from the three dogmatic filters characteristic of objective imputation: the creation or increase of an unpermitted risk, the realization of that risk in the result produced, and the belonging of said result to the scope of protection of the infringed norm of care. From this perspective, factual causality, understood as conditio sine qua non, functions only as a prior logical budget for the judgment of imputation, but not as an autonomous or additional normative level. Its verification is indispensable for the imputation analysis to begin; but the legal-criminal relevance of the link between conduct and result is resolved entirely in the plane of objective imputation (Puppe, 2001, p. 11).

1. Methodology

This is a dogmatic legal investigation (Valencia, 2017, p.8) developed from an analytical normative approach, which is oriented toward reconstructing, through general dogmatics, the conditions for the attribution and exclusion of criminal liability within cases of medical malpractice from the theory of objective imputation.

Similarly, the methodology does not pursue the empirical description of clinical practices or the quantification of phenomena; on the contrary, it formulates auditable legal criteria to carry out the imputation or exclusion of the harmful result in accordance with the criminal categories of the objective duty of care and lex artis as technical parameters of ex ante specification, as well as the criteria of permitted risk, creation of unpermitted risk, realization of the risk, and scope of protection of the norm of care.

Considering that the methodological product is a rule of decision, the criminal imputation of the result is only admissible when the normative filters of the imputation scheme concur cumulatively, so that, in the absence of any of them, the result is concentrated in the field of permitted risk and, therefore, imputation must be excluded.

For its part, the material for analysis is mainly composed of systematic criminal doctrine and dogmatic developments related to objective imputation applied to medical liability, complementing specialized literature on lex artis as a technical reference standard, used exclusively as input to specify the care due and not as an autonomous criterion for criminal attribution.

Thus, priority is given to treaties and monographs of the general part with systematic reconstruction of objective imputation, together with specialized studies on medical criminal liability, excluding merely casuistic approaches or arguments anchored solely in the severity of the outcome. As an express methodological premise, the infringement of lex artis is not equivalent on its own to criminal imputation, because all attribution requires the verification of three important categories: firstly, the creation of a legally disapproved risk; secondly, the realization of the risk in the result; and thirdly, the belonging of the result to the scope of protection of the violated norm of care, which avoids the automatism of the damage = crime or technical deviation = criminal liability type.

1.1. Approach and analysis design

The design of the analysis is reconstructive, sequential, and cumulative. Therefore, in a first phase, operational definitions and conceptual boundaries were established, aimed at preventing extra-penal displacements. Firstly, medical malpractice, which is used as a criminal category only when there is a normatively relevant infringement of the objective duty of care (Martínez, 2011, pp. 217, 235); secondly, the lex artis is understood as an ex ante, general, and contextual technical standard, suitable for specifying the required care but insufficient for imputing results (Cordini, 2017, pp. 445-446) without the complete judgment of objective imputation; and finally, thirdly, permitted risk is formulated as a normative limit of criminal tolerance regarding risks inherent to diligent medicine. Thus, this phase strictly distinguishes the technical-professional plane from the legal-criminal plane, thus avoiding converting professional standards into substitutes for the judgment of typicity.

Consequently, in a second phase, the analysis must be oriented based on three cumulative filters. First, it is appropriate to determine whether the conduct created or increased a legally disapproved risk, which presupposes an infringement of the duty of care defined by the lex artis. Second, it must be verified that this risk has materialized in the produced result, since attribution is discarded when the outcome responds to alternative causal courses or the materialization of a risk other than the one introduced by the conduct. Finally, the third filter addresses the belonging of the result to the scope of protection of the infringed care norm, excluding the imputation of those results that, although causally connected to the action, do not correspond to the type of outcome that said norm seeks to avoid.

Along the same lines, it should be noted that the criteria of suitability and objective foreseeability do not constitute an autonomous level of legally relevant causality juxtaposed to objective imputation (Bauer, 1981, p. 282), but rather are inserted into the first filter of it, that is, into the normative judgment concerning the creation or increase of a legally disapproved risk.

In other words, the question regarding the suitability of the conduct to produce the result and the objective foreseeability of it does not refer to a prior causal issue, but is part of the risk disapproval judgment itself, as pointed out by (Puppe, 2001, pp. 11, 15-17) when drawing a clear distinction between the nomological explanation of the causal course and the normative attribution of the result. This avoids both causalist mechanism and the drift toward liability for the mere result, characteristic of classical causalist constructions (González & San José, 2023, pp. 4-5).

As mechanisms of internal validity, argumentative traceability protocols are applied, where every conclusion of imputation or exclusion of it must necessarily make explicit the satisfied or failed filter, as well as the normative reason for that decision, so that the inferential itinerary is objectively controllable by third parties.

In the same vein, this control incorporates an express caution against ex post biases, particularly relevant in scenarios of therapeutic uncertainty, clinical urgency, limitation of means, and division of healthcare labor, where the retrospective reconstruction of the standard tends to distort the real exigibility of due care.

1.2. Delimitation of the object and analysis criteria

The study is limited to reckless criminal liability due to medical acts in contexts of action or omission, insofar as there are specific duties of action or control, excluding the autonomous development of extra-penal regimes and the systematic examination of intentional cases, as they are not necessary for the dogmatic rule proposed; this delimitation seeks to prevent the severity of the result from influencing and even replacing the judgment of imputation, ensuring that criminal attribution remains governed by the criteria of culpability (Dsouza, 2015, p. 452; Gomes & Pizzotti, 2024, p. 4; Mañalich, 2023, p. 215; López & Sánchez, 2022, p. 291) and by the prohibition of objective liability.

Within this same delimitation, it should be noted that the analysis is deliberately limited to the objective plane of the reckless unjust, without addressing the issues proper to the subjective duty of care or subjective imputation in the strict sense; this restriction is not due to a lack of knowledge of its dogmatic relevance, which is particularly significant both for the delimitation of the behavioral norm and for the individualization of the reproach, but to a methodological decision consistent with the architecture of the proposal.

Indeed, the sequential-cumulative rule proposed operates at the level of the reckless objective type, conceptually prior and autonomous with respect to the judgment of culpability (Gómez, 2022, p. 766), so that it can be formulated and verified without resorting to valuations regarding individual foreseeability, the author’s special knowledge, or the concrete exigibility of alternative conduct in accordance with Law.

In this framework, the subjective duty of care and the categories of subjective imputation belong to a different dogmatic stratum, the treatment of which would require specific development alien to the purpose of this research, focused on the construction of a general dogmatic guide on the normative filters of objective attribution of the result.

In the same sense, the principle of reliance is examined here exclusively in its objective dimension, that is, as a criterion for delimiting the scope of responsibility between participants in contexts of coordinated healthcare action, without ignoring that it also admits a reading from subjective imputation that exceeds the object of this study.

It is not, therefore, an omission, but an express methodological delimitation; the sequential-cumulative rule is offered as an architecture of the reckless unjust, and not as a complete theory of reckless crime; the eventual articulation of this proposal with the categories of subjective imputation thus remains open as a further line of development.

Consequently, the analysis contained in this work seeks the application of three cumulative filters, such as the primacy of objective imputation over mere causality; the ex ante valuation of due care in accordance with the criteria exposed by the lex artis, excluding retrospective reconstructions; and the control of systematic coherence, which preserves the non-overlapping functions existing between categories. Therefore, within the context of coordinated healthcare action, the principle of reliance operates as a delimiting criterion to exclude imputations for acts of others (Bracho, 2025c, p. 249), except for the concurrence of duties of control or alarm signals that invoke obligations of intervention.

2. Permitted risk and objective imputation in medical criminal liability

From a mainly dogmatic approach, criminal imputation in cases of medical malpractice is based on the infringement of the objective duty of care that the physician must observe during the performance of the medical act. In the words of Wessels et al. (2024, p. 355), objective imputation within the medical field has as a central parameter the concept of “legally disapproved risk,” whose criminal relevance lies in the professional’s conduct that, when normatively assessed, deviates from the required criteria of care.

Along these lines, lex artis cannot be understood as an autonomous criterion for criminal imputation, given that ontologically it is a technical parameter that allows establishing the connection with the objective duty of care; therefore, its assessment must necessarily be carried out ex ante, clearly linked to the specific circumstances of each action.

For this reason, its infringement can only acquire criminal relevance when it is integrated into a judgment of objective imputation supported by the prior verification of factual causality; consequently, the mere verification of a deviation from the applicable technical standard is insufficient, in itself, to ground criminal imputation.

Lex artis, in turn, is not static, so it must be understood as a dynamic and evolutionary manifestation of the scientific-professional standards that govern medical practice (Solé, 2022, p. 6), which gives the concept of malpractice a component of contextuality and constant updating; this approach is undoubtedly enriched by pointing out that lex artis is a construct in permanent modification, subject to scientific progress that continuously redefines the required duty of care.

However, the intrinsic evolutionary nature of lex artis does not imply indeterminacy, since its content is determined based on standards that are recognizable and accessible ex ante in the context of action, and not through retrospective reconstructions guided by the outcome.

Based on these conceptual premises, and once factual causality between conduct and result has been established as a prior prerequisite, criminal imputation in the context of medical malpractice is structured from three dogmatic filters, of a normative and cumulative nature:

1. The creation or increase of a legally disapproved risk: The first filter requires determining whether the medical conduct created or increased a legally disapproved risk, which in the medical field operates through the infringement of the objective duty of care; for this, it must be established whether the physician deviated from the care required in accordance with technical professional standards, since the physician must observe current protocols and norms, not only those that are explicitly legal, but also clinical standards and hospital protocols. Such instruments, which find their concretization through lex artis, must be understood as criteria for specifying the duty and not as an autonomous source of imputation, so that their transgression constitutes the mechanism that allows affirming the creation of the criminally disapproved risk. Since not every medical error is criminally relevant, this condition is met when the margins of tolerable risk are exceeded and such exceeding is incompatible with the due care. As Silva Sánchez (2011, p. 29) warns, the mere existence of an adverse result cannot automatically lead to a criminal imputation; for medical action to be criminally relevant, it must be directly linked to conduct that has involved a transgression of the duties inherent to the medical function, generating a risk to which criminal legislation can grant legal reproach.
2. The realization of the risk in the result: The second filter requires that the harmful result constitutes the concretization of the created unpermitted risk and not the materialization of an alternative causal course derived from a different risk, thus preventing imputations for adverse outcomes that, although coexisting temporally with the medical conduct, do not have normative correspondence with the danger introduced by it.
3. The belonging of the result to the scope of protection of the infringed care norm: The third filter requires that the harmful result is perfected in the harmful result that the unfulfilled care norm seeks to avoid; so those results cannot be imputed that, even having a causal relationship with the conduct and coming from a legally disapproved risk, fall outside the scope of protection of that norm. Such a filter functions as a final limit within the dogmatic analysis, preventing criminal liability from extending to consequences that do not belong to the scope that the objective care norm intended to protect.

As noted, these three filters operate as a cumulative and hierarchical test: the verification of the first is a necessary but not sufficient condition; only the cumulative concurrence of all three levels allows for criminal imputation. This avoids both liability derived from the mere result and a kind of uncritical transfer of technical standards to the level of typicality, which preserves the protective function of objective imputation as a criterion for the normative attribution of the result.

In addition to what has been stated, the view of permitted risk imposes the need for it to be analyzed within the context of medicine as a practice that cannot guarantee the absolute elimination of risks. As argued by (Caro, 2023, p. 57; Muñoz & García, 2010, p. 293), medicine is not an exact science but a practice underlying a significant margin of uncertainty and inherent risk; therefore, the weighing of medical criminal liability must include a detailed assessment of the margins of uncertainty and the risk inherent in the exercise of diligent medical practice. Consequently, criminal imputation cannot extend to every adverse result, but only to those that are attributable to an action that exceeds the reasonable limits of the permitted risk that physicians are authorized to assume within professional standards.

2.1. Permitted risk as a normative limit of criminal imputation

The category of permitted risk occupies a central place within contemporary criminal dogmatics, insofar as it explains why not every conduct causally connected to a harmful result enables, by that fact alone, a criminal-legal attribution. In that sense, its consolidation responds, in large measure, to the insufficiency of classical causalist conceptions, especially those that, by operating with a mechanical link between conduct and result, became incapable of satisfactorily justifying the exclusion of liability when the danger generated remained within normatively tolerated margins; in this sense, permitted risk functions as a containment category against the expansion of criminal reproach and as an indispensable tool to exclude slips toward forms of liability for the mere result.

From a dogmatic perspective, permitted risk should not be understood as the mere social acceptance of danger nor as a simple empirical verification that an activity implies frequent or inevitable risks. Rather, it constitutes a prior normative criterion that allows establishing in which cases a dangerous conduct still remains within the sphere of legally legitimate action. For this reason, as long as said threshold is not exceeded, it is not possible to move from mere factual causality to the criminal-legal imputation of the result.

Its function, however, does not consist in denying that risk exists, but in specifying when that risk, despite its danger, remains within what is tolerated by the legal system in attention to the structure, utility, and social necessity of certain activities, among them, pragmatically, medical practice.

Now, it is convenient to clarify that the articulation between permitted risk, recklessness, and objective imputation does not constitute a peaceful matter. Indeed, a relevant sector of doctrine maintains that recklessness retains conceptual autonomy, as it is structured mainly on the infringement of the objective duty of care and the exceeding of the permitted risk. From this perspective, objective imputation allows verifying whether the created risk materialized in the produced result and whether it possesses criminal-legal relevance within the applicable normative framework.

Without ignoring that controversy, this work adopts, for analytical and expository purposes, an integrative reconstruction of a sequential-cumulative nature; under this methodological option, permitted risk operates as a negative prerequisite for the judgment of imputation, because if the conduct remains within the due care ex ante, the creation of a legally disapproved risk cannot be affirmed and, consequently, the attribution of the result in the criminal venue is blocked.

This position does not intend in any way to close the dogmatic discussion, but to specify the conceptual framework from which the analysis is ordered. In the reconstruction assumed here, the relationship between the infringement of the objective duty of care and the creation of an unpermitted risk cannot be understood as the simple sum of two autonomous assessments. Rather, both categories must be understood as normative dimensions closely articulated within the same judgment of imputation.

In other words, the infringement of the duty of care, specified ex ante from recognizable and contextually accessible standards, only acquires criminal relevance insofar as it translates into the creation or increase of a legally disapproved risk; and conversely, the affirmation of an unpermitted risk requires showing itself as an expression of a legally relevant deviation regarding the due care; therefore, such precision is decisive to avoid both the artificial splitting of categories that, in the reckless unjust, operate closely linked, and the reduction of the analysis to a merely technical or retrospective verification of the medical error.

Hence, permitted risk can be understood as the normative limit that prevents affirming the creation of a disapproved risk when the conduct remains within the due care, assessed from an ex ante perspective. Consequently, if that threshold has not been exceeded, criminal imputation must be excluded, even when a serious or socially shocking harmful result has occurred.

On the contrary, when the conduct exceeds normatively tolerated margins, an opening is then made to a subsequent examination aimed at determining whether the unpermitted risk was realized in a result and whether this is included within the scope of protection of the infringed care norm. From this perspective, permitted risk does not suppress the need for a further judgment of imputation of the result, but it does fulfill a decisive function that consists in preventing such a judgment from being activated when there is a lack, from the beginning, of a legally relevant deviation from the required standard.

In the medical field, this requirement acquires particular intensity, since medicine develops in a context marked by uncertainty, by inevitable margins of error, and by constant exposure to risks that can affect legal interests of maximum relevance.

Precisely for this reason, Criminal Law cannot operate with expectations of infallibility nor reconstruct ex post the correctness or incorrectness of the conduct based on the harmful result; since permitted risk fulfills here a protective function of the first order by delimiting the sphere within which medical action, despite its inherent danger and despite the eventual production of harmful results (Erbaş, 2026, p. 4), remains within what is legally tolerated, insofar as it conforms to the objective duty of care in accordance with available information, accessible means, and concrete conditions of action; only when that framework is exceeded can the transition from the risk inherent to medical activity toward a legally disapproved risk be sustained.

This delimiting function is not satisfied with the mere verification that the activity is socially useful nor with the generic reference that the risk is normal or common; the decisive thing is to verify with an ex ante judgment and with intersubjective control whether the conduct remained within the normative framework that defined legitimate action in the specific case.

This examination imposes the need to consider at least four concurrent parameters, which are not conceived as an autonomous category, but as an analytical systematization of recurrent demands in the dogmatics of permitted risk. The first refers to the adjustment of the conduct to the objective duty of care, whose concretization in the particular medical field refers to recognizable and contextually applicable professional standards; second, it concerns the intrinsic and functional nature of the risk regarding the legitimate clinical act, so that its danger does not represent an excess unrelated to the therapeutic or assistance purpose; third, it requires that said risk remain within normatively acceptable thresholds in the specific case, thus excluding the unnecessary increase of danger derived from defective execution or the omission of required precautions; finally, it demands that the conduct conserve a structure of predictability and control ex ante, without displacing the causal course toward a sphere of chance, lack of control, or excessive affectation of the legal interest.

When these parameters concur, the risk remains within the space of legal tolerance and, therefore, the affirmation of creation of a disapproved risk is blocked; when, instead, a relevant deviation regarding them occurs, the subsequent judgment remains open as to whether that risk materialized in the result and whether said result is included within the scope of protection of the objective care norm.

In support of the above, the function of permitted risk is not merely negative or exclusionary; it also orders the imputative reasoning, as it determines the point from which the criminal-legal analysis can advance without being confused with a logic of liability for the mere result.

Doctrine has contributed decisively to consolidate this understanding. Roxin (2006, pp. 371–372) highlights that permitted risk acts as a regulative criterion that excludes imputation when the assumed danger is inherent to socially useful activities and remains within legally acceptable margins; for its part, Jakobs (2003, p. 243), from a functionalist reading, insists that not any risk can be considered reproachful, but only that which overflows the framework of normative expectations that order social behavior.

In that same line, Welzel (1969, pp. 132, 136) and Mir Puig (2011, pp. 299, 302–304) reinforce the idea that, in the reckless unjust, punishability does not depend simply on a result being produced, but on a normatively relevant deviation being verifiable against the due behavior. Although these approaches may not be entirely coincident, they converge on a decisive point: the harmful result can only be legally imputed when it expresses the concretization of an excess regarding the permitted risk, and not the simple manifestation of the dangers inherent to a lawful and socially necessary activity.

Thus, the determination of permitted risk cannot be conceived as a sociological operation nor as an empty formula, since it is a normative, contextual, and intersubjectively controllable construction, dependent on ex ante standards, on objectifiable patterns of care, and on dogmatic criteria that allow differentiating between clinical damage tolerated by the legal system and the criminally relevant unjust.

In the medical field, this precision is indispensable to preserve a double requirement; on one hand, to prevent ius puniendi from unduly invading the space of risk inherent to diligent practice and, on the other, to prevent the structural inevitability of sanitary risk from functioning as coverage for serious deviations from due care.

In synthesis, permitted risk constitutes, in this research, an indispensable dogmatic tool to delimit the boundary between legally tolerated medical action and that which enables criminal imputation; since its function is double: on one hand, it fulfills a protective function, by excluding attributions built only from the result or from retrospective reconstructions of behavior.

On the other hand, permitted risk fulfills a delimiting function, insofar as it marks the threshold from which the infringement of the objective duty of care can become the creation of a legally disapproved risk. Only once that limit is exceeded is it possible to open the judgment of imputation of the result. Understood in this way, permitted risk acquires a central role, as it allows maintaining criminal intervention within parameters of rationality, certainty, and rejection of objective liability, without thereby weakening the effective protection of legal interests against risks that exceed what is legally admissible.

2.2. Lex artis and the objective duty of care in medical malpractice

From a strict dogmatic perspective, lex artis fulfills a technical-professional function of specifying the objective duty of care within medical practice, as it provides the specialized parameter that builds the bridge allowing for the translation of clinical context into actions performed in accordance with due care.

Its status, therefore, does not correspond to that of an autonomous source of typicity or a self-sufficient criterion of criminal imputation, as it operates solely as a technical datum integrated into the legal judgment on the duty of care. To that extent, it is articulated with the structure previously defined; that is, with the determination of whether the conduct remained within the sphere of permitted risk or whether, conversely, it introduced or increased a legally disapproved risk.

Hence, its infringement is not automatically equivalent to criminal liability, just as its observance does not constitute by itself an absolute shield against any imputation. Acting in accordance with lex artis is not irrelevant; however, even when technical correctness is verified, the criminal attribution of the result requires overcoming the normative filters of objective imputation. These are not satisfied by the mere finding of the clinical standard, making the normative transition from permitted risk to unpermitted risk and its subsequent realization in the result, in accordance with the filters of objective imputation, decisive in the criminal sphere.

For analytical purposes, and not as a rigid ontological classification, lex artis can be broken down into two complementary planes that allow for the operationalization of its ex ante function: a general plane and an ad hoc plane. Consequently, lex artis in a general sense refers to the set of generally recognizable professional standards that structure the technical correctness of the medical intervention.

Its dogmatic relevance lies in its contribution to stabilizing the judgment of the objective duty of care through objectifiable and intersubjectively controllable parameters (Bracho, 2025a, p. 105), as a mechanism for reducing arbitrariness in the criminal evaluation of professional conduct. In this vein, Muñoz Conde and García Arán (2010, pp. 285, 287) underline the role of these general standards for the delimitation of the care due, so that an unjustified departure may constitute a relevant indication of infringement of the objective duty of care (Tixi et al., 2020, pp. 244, 248), provided, of course, that such indication is subjected to the normative filters of imputation required by Criminal Law.

For its part, lex artis in an ad hoc sense expresses the dogmatic requirement to contextualize the technical standard to the concrete circumstances of the intervention, without relativizing the core of the duty of care (Mattheudakis, 2020, pp. 238, 243–244; Perin, 2019, pp. 7–9). Indeed, medical practice develops under variables and conditions that affect what is effectively demandable from a competent professional in that context.

Consequently, the criminal evaluation must avoid retrospective reconstructions guided by the outcome (ex post bias) and focus on formulating an ex ante judgment, maintaining the perspective of the moment of action, in light of the clinically available information and the standards objectively applicable at that time. As (Silva, 2001, p. 49) warns, Criminal Law cannot operate with abstract patterns that are disconnected from the real conditions of healthcare provision, as this favors the proliferation of disproportionate imputations and, logically, such a situation compromises the prohibition of objective liability.

However, contextualization does not equate to a license to lower the standard; it only modulates what is demandable when the limitation was truly insurmountable and recognizable ex ante, and in cases where there were no alternatives reasonably compatible with the due care. To that effect, if technically available and reasonably demandable courses of action existed, the context cannot function as an alibi to legitimize avoidable deviations.

At this point, it is fundamental to prioritize the normative weight of the different inputs that are usually invoked as standards (Mayer, 2011, p. 385), as not every protocol, guideline, or practice has identical force to specify the objective duty of care. Likewise, the dogmatic relevance of a standard depends, among other factors, on its professional recognition, dissemination, or even its degree of scientific consolidation, followed by the level of institutional mandatory nature and compatibility with the state of the art.

The criminal valuation judgment must necessarily be oriented toward confirming the standard used, verifying whether it fulfills a function as a reasonable technical parameter regarding the construction of the notion of due care; it is highlighted that this valuation must necessarily be circumscribed within a specific temporal and contextual framework.

In support of what has been argued, it is revealed that, in cases where different standards concur, preference must be given to the one that ex ante possesses greater scientific, institutional, and normative solvency. From such precision arises the need to avoid the presence of two symmetrical risks: the first manifested in the pretension to convert lex artis into a system of automatic imputation due to formal deviation, and the second referring to the dilution of the category until it becomes a purely theoretical or even irrelevant manifestation.

Having clarified the above, it must be understood that the interaction between lex artis and criminal liability requires a dogmatic sequence without leaps. First, the factual causality (conditio sine qua non) existing between the conduct and the result must be verified in the general terms of causal analysis (Acosta et al., 2025, p. 379; Calahorrano, 2022, pp. 2, 11), because, without this prerequisite, any subsequent discussion lacks an object.

Secondly, the examination of objective imputation corresponds, which, in cases of malpractice, requires determining whether the conduct created or increased an unpermitted risk and whether that risk was realized in the result, as well as whether the result is within the scope of protection of the applicable care norm.

Again, in this dimension, lex artis provides technical data to support or discard the infringement of due care and thus grounds or denies the creation or increase of the disapproved risk, but this does not replace the normative judgment. In this sense, Wessels et al. (2024, pp. 77–78) emphasize that objective imputation requires the reconstruction of the nexus between conduct and result from the perspective of the legally relevant risk.

Therefore, it is not enough to establish a mere empirical connection between conduct and result. It is necessary to demonstrate that the result was produced through a legally relevant contribution, derived from a normatively reproachful risk (Maldonado, 2023, pp. 576–577). In that sense, when a medical professional departs from the lex artis, it is not sufficient to confirm said deviation. It must also be accredited how that infringement introduced or increased a risk beyond the legally tolerable threshold, as well as demonstrating that the result constitutes the realization of that risk and not a simple manifestation of the permitted risk inherent to medical activity.

Thirdly, in cases of reckless crimes, the attribution of the result requires the incorporation of a normative judgment of relevance that fulfills a containment function against the exercise of punitive power and avoids, by that path, imputations based on the mere harmful outcome.

It is convenient to warn, following the conceptual precision formulated by Puppe, that the analysis of the nexus between conduct and result unfolds on two conceptually distinct, although sequentially linked, planes. On a first plane, of a descriptive nature, factual causality understood as conditio sine qua non must be established as a minimum prerequisite, since without it there is no possible object of imputation.

On a second, properly normative plane, the legal-criminal attribution of the result requires that it represent the realization of the legally disapproved risk created by the conduct, and that it also be understood to fall within the scope of protection of the infringed care norm. From the reconstruction assumed here, the criteria of suitability and objective foreseeability, traditionally invoked under the label of legally relevant causality (Carrancá & Lagares, 2016, p. 59), must be understood as elements constituting the first filter of objective imputation; that is, the creation of the disapproved risk, and not as an autonomous stratum interposed between causality and imputation.

To what has been stated above, the characteristic component of the reckless unjust is added, consisting of avoidability in accordance with care. This point must be defensible through rational criteria (De Carvalho, 2020, p. 438), in which conduct in accordance with the objective duty of care would have avoided the result or would have relevantly reduced its probability of production, thus discarding imputations based on irresolvable uncertainties inherent to the medical act or on expectations of infallibility incompatible with medicine (Martínez, 2023, pp. 151, 156).

As a conclusion to what has been exposed, it is highlighted that such avoidability does not imply the transfer of the analysis to the subjective plane of culpability (Aguirre, 2010, pp. 234, 244; Schünemann, 1991, pp. 164–165, 172), but rather the correct closure of the reckless unjust within its normative dimension, because, without avoidability considering the duty of care, the imputation of the result dangerously approximates a liability for result.

2.3. The sequential-cumulative rule in its practical application

2.3.1. Jurisprudential criteria and paradigmatic cases

The sequential-cumulative rule acquires special relevance in cases where the criminal attribution of the result may be conditioned by retrospective reconstructions, especially in contexts of clinical urgency, lack of means, and high decisional complexity. In these scenarios, jurisprudence provides useful precedents that, without exhausting the dogmatic discussion, allow for a concrete demonstration of the utility of the model proposed here.

From a comparative perspective, the jurisprudence of the Spanish Supreme Court has indicated that the reckless crime presupposes avoidable conduct that exceeds the permitted risk, the typicality of which must be determined by confronting the conduct actually deployed and that required by the objective duty of care.

This formulation refers to the general theory of criminal recklessness, incorporated in STS 1050/2004 (Supreme Court, Second Chamber, Criminal, 2004), a criterion that has been subsequently reiterated in decisions such as STS 1210/2023 (Supreme Court of Spain, 2023, pp. 6-7), relating to a case of injuries due to professional recklessness derived from a surgical intervention performed on a limb other than the one programmed.

In the latter, the court indicates that the essence of the reckless action rests on the infringement of the duty of care and that the objective type requires the exceeding of the permitted risk coupled with the objective imputation of the result; however, all of this must be assessed from an ex ante valuation. Consequently, even when there is no full identity between both constructions, this jurisprudential line is consistent with the reconstructive architecture assumed here and confirms the need to avoid assessments based exclusively on the harmful result.

For its part, in the Chilean legal system, the medical quasi-delict finds its typical foundation in article 491 of the Criminal Code (Criminal Code, 1874, art. 491), a provision that sanctions the health professional who, with culpable negligence in the exercise of their profession, causes harm to persons.

On this normative basis, the Supreme Court has systematized the prerequisites of the quasi-delict around the professional condition of the author, the concurrence of culpable negligence, the production of harm to the person of the patient, and the existence of a link between the conduct deployed and the harmful result.

A paradigmatic example is offered by the judgment of April 23, 2007, Rol 6585-06 (Supreme Court of Chile, 2007, p. 12), relating to an emergency intervention performed in the Emergency Unit of the San José Hospital, in which a surgical clamp was left forgotten in the patient’s abdominal cavity and it was necessary to re-operate, prolonging their convalescence.

In said case, despite the existence of a material error and a relevant harmful result, the Supreme Court revokes the conviction for quasi-delict of simply serious injuries and acquits the physician, on the basis of an ex ante reconstruction of the lex artis that leads to denying a qualified infringement of the objective duty of care, and with it, to excluding that the result can be imputed as the realization of an unpermitted risk different from the risks inherent in emergency surgery.

From the perspective of the sequential-cumulative rule, this ruling clearly shows how the verification of factual causality and harm does not exhaust the judgment of reckless typicality; by successively applying the filters relating to the objective duty of care, the permitted risk, and objective imputation, the chain of imputation is interrupted before justifying the affirmation of criminal liability.

In turn, the Constitutional Court, among other decisions, in judgment Rol No. 3445-17, of October 4, 2018 (Constitutional Court of Chile, 2018, pp. 4-5), has reaffirmed that article 491 of the Criminal Code (Criminal Code, 1874, art. 491) describes a special type of quasi-delict that requires the culpable infringement of a professional duty of care and cannot operate as a liability regime for the mere result, discarding that its application to certain members of the healthcare team can be based on an in malam partem analogy.

From the perspective proposed in this research, such precedents show that Chilean jurisdictional practice already contains, although not always systematically, requirements compatible with an ordered reconstruction of permitted risk, the infringement of the objective duty of care, and the objective imputation of the result in line with the sequential-cumulative model proposed here.

On that background, the sequential-cumulative rule can be illustrated by the contrast between cases that remain within the permitted risk and cases that transcend them. Think, first of all, of an emergency surgery performed in a hospital establishment with limited technical resources, in which the medical team must choose between transferring the patient to a center of greater complexity, which entails a clinically significant delay, or intervening immediately with the available means.

In this sense, if the team decides to intervene following recognized emergency protocols, adopts the surgical option that ex ante emerges as reasonable, given the concrete conditions of action, and documents the decision according to the lex artis ad hoc, an eventual serious complication cannot be criminally imputed as the realization of an unpermitted risk, but must be understood as the realization of a risk inherent in diligent medical activity developed in conditions of uncertainty and limitation of means.

In that case, the rule allows for verifying the factual causality between the intervention and the result, but leads to excluding imputation, as the first normative filter, in that a relevant deviation regarding the contextually demandable objective duty of care is not accredited.

An analogous conclusion is imposed in cases of diagnostic error committed in emergency services when the physician has applied the clinical criteria and tests reasonably available at the time of the action, but subsequent evolution reveals an atypical pathology or one difficult to detect ex ante; here the caution against ex post bias reaches its maximum relevance, as it forces the reconstruction of the judgment on the care due from the information available at the time of acting and not from data that only emerged subsequent to the outcome.

On the opposite end are those cases in which the professional incurs a qualified deviation regarding the demandable standard that finds no justification in the context of action, for example, unjustified omission of mandatory clinical protocols whose observance was demandable in the specific case, gravely defective technical execution outside the difficulties inherent in medicine, or neglect of basic precautions reasonably accessible ex ante.

When that deviation relevantly increases the risk of the harmful result and said result constitutes precisely what the care norm intended to avoid, the sequential-cumulative rule allows for verifying the concurrence of the three objective imputation filters: the conduct creates or increases a legally disapproved risk, that risk is effectively realized in the result, and the result belongs to the scope of protection of the infringed norm. In this way, the affirmation of criminal imputation remains supported without the need to resort to general presumptions built from the sole production of the damage nor to automatic equivalences between technical deviation and reckless typicality.

2.3.2. Principle of reliance in healthcare action contexts

The division of labor in multidisciplinary teams constitutes a structural feature of contemporary medical practice and this gives rise to specific problems in the delimitation of the scope of responsibility corresponding to each participant. In this framework, the principle of reliance operates as a normative criterion according to which each professional can start from the expectation that others will adequately fulfill their own duties, without being thereby forced to a constant supervision of the actions of others, except in the presence of alarm signals or specific duties of control.

In accordance with the adopted methodological delimitation, this principle is examined in its strictly objective function, that is, as a delimiting criterion of the scope of criminal liability between the different participants in the medical act, and not in its eventual projection on the subjective plane of the unjust.

In such a sense, it should be warned that the principle of reliance does not operate absolutely; it can only be validly invoked by one who has diligently observed their own professional duties in the concrete context, so that one who has failed to comply with the basic standards of care that were personally demandable cannot shield themselves in the action of third parties to exclude their responsibility.

From the perspective of the sequential-cumulative rule, the principle of reliance is integrated into the first filter of objective imputation (Pérez, 2009, p. 1410), because it contributes to specifying whether the professional’s conduct remained, ex ante, within the scope of due care in contexts of coordinated action.

In this way, in a scenario of emergency surgery, characterized by a functional division of labor between surgeon, anesthesiologist, and nursing staff, if the physician has fully observed the inherent duties and no alarm signals concur that reasonably imposed an additional duty of control over the action of the other participants, the realization of a risk derived from the errors of others cannot be attributed to them as the creation of an unpermitted risk.

Correlatively, when the professional has omitted own duties of surveillance or has neglected alarm signals that reasonably should have activated them, the rule allows for affirming the infringement of the duty of care and eventually, the imputation of the result, without dissolving the boundaries between individual liability and liability for acts of others.

From what has been stated above, it follows that the combined examination of these cases confirms the discriminating capacity of the sequential-cumulative rule to distinguish between adverse results that remain within the risk inherent in medical activity and results that, by deriving from a qualified deviation from the objective duty of care, legitimately enable the intervention of Criminal Law.

Conclusions

This work aimed to establish, with the pretension of a general dogmatic guide, a framework for criminal attribution regarding medical malpractice, which would allow for rigorously distinguishing between clinical damage and criminally relevant wrongfulness, thus avoiding both liability for the result and impunity in the face of serious breaches of the duty of care.

Consequently, the thesis structuring the analysis is clear: criminal imputation is only sustainable when, from an ex ante judgment—which must be intersubjectively controllable—the medical conduct exceeds the permitted risk, and such excess is normatively reconstructed through objective imputation, using the technical support of the lex artis.

It is necessary to understand that medical practice, by ontology, structurally unfolds within an environment of uncertainty and inevitable risks, and it is precisely for this reason that Criminal Law cannot operate with expectations of infallibility nor with retrospective reconstructions guided by the outcome, without betraying its principles of limitation.

It was demonstrated that permitted risk fulfills a decisive containment function. It operates as an ex ante normative threshold that acts as a dam against imputation while the conduct remains within the due care, blocking the expansion of ius puniendi into the space proper to the inherent and socially functional risk of the medical act.

Nor is it a sociological formula, but a normative criterion that, as a negative prerequisite of the first filter of objective imputation, requires that criminal attribution be supported by the creation or increase of a legally disapproved risk and not by the mere production of damage.

In sum, the lex artis is delimited with conceptual precision; since it does not constitute an autonomous source of typicity nor automatically converts a technical deviation into a crime, its status is that of a technical-professional standard integrated into the legal judgment of the due care; this allows for specifying, with intersubjective control, what was exigible within the evaluated clinical context.

The analytical distinction between a lex artis of general reference and an ad hoc lex artis does not introduce any form of relativism; on the contrary, it allows operationalizing the objective duty of care under the real conditions of healthcare provision, preserving the methodological rule that must guide every criminal assessment in this field. In this way, ex post bias is avoided, and medical action is reconstructed from an ex ante perspective, attending to the available information, accessible means, and standards objectively applicable at the time of the decision.

On the basis of the arguments put forward, three concrete dogmatic contributions are generated; the first is that it delimits the function of permitted risk as a normative limit of criminal imputation in the medical field, which reinforces its protective role as a barrier against imputations based solely on the result.

Secondly, the status of the lex artis is specified as a necessary technical datum, but one that is insufficient on its own, which prevents it from settling into an automatic rule of typicality, ordering that its use be found within a rigorous imputation sequence.

Thirdly, a rule of clinical case reconstruction is formulated which is compatible with the principle of culpability and the prohibition of objective liability, because the assessment must be carried out ex ante, and the attribution of the result requires demonstrating that the harmful outcome constitutes the realization of an unpermitted risk and is not the manifestation of an inherent risk.

With this, the dogmatic conclusion is unequivocal: medical criminal liability requires a structural sequence without leaps, where: first, the verification of factual causality as a prerequisite; second, objective imputation as a normative filter; third, in the reckless sphere, the requirement of avoidability in accordance with the duty of care, so that the attribution is not based on irresolvable uncertainties nor on expectations of clinical perfection incompatible with healthcare practice. Only when the concurrence of these levels is verified in a concurrent and cumulative form is it possible to criminally impute a result without unduly expanding ius puniendi and without protecting the patient against conduct gravely deviated from the due care.

Likewise, it is convenient to delimit the scope of this framework to reinforce its robustness, because the article aims to serve as a general dogmatic guide and, therefore, does not intend to replace the positive determination of clinical standards with specific scientific-medical controversies, nor to exhaust the normative variants proper to each legal system or its particular case-law.

Thus, an imputation architecture was built, and especially the rules of transition between permitted risk and unpermitted risk were defined with precision, so that such criteria can be applied and specified by doctrine and institutional practice in accordance with the sources, standards, and conditions proper to each system.

In sum, a criminal dogmatics consistent with medical malpractice must resist two symmetrical temptations: on one hand, impunity resulting from the trivialization of serious breaches of the duty of care; and, on the other hand, expansive criminalization that converts the inevitable error or the inherent risk of medicine into a criminal reproach.

Consequently, the reconstructed legal framework allows for safeguarding the legal certainty of the medical professional without leaving the patient unprotected, by reserving criminal intervention for those cases that are strictly delimited.

Finally, the developed proposal does not seek to close the discussion, but to contribute a criterion to delimit medical malpractice in the sphere of the criminally relevant. On that basis, an investigative agenda is left open aimed at linking the architecture of the reckless unjust with the categories of subjective imputation and with the specific problems raised by medical decision-making in scenarios of risk and uncertainty.

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Funding: Universidad Tecnológica Metropolitana within the framework of the development and strengthening of the research line: “diverse contexts of vulnerability and Criminal Law”.

Acknowledgments: To my family for their permanent support and patience, to the Universidad Tecnológica Metropolitana for the opportunities provided, especially to my students who always encourage me to continue advancing in the strengthening of scientific knowledge and the work of Law. Finally, to the editorial committee and the reviewers for the feedback and comments that were useful to strengthen the initially presented scientific proposal.

Conflicts of interest: This article does not involve any conflicts of interest.

Authorship contribution: Pedro Luis Bracho-Fuenmayor: Conceptualization, Writing - review and editing, Writing - original draft, Investigation.

Use of artificial intelligence tools: The author declares that no artificial intelligence tool has been used in the writing, analysis, or review of this article.