Desde esta última reflexión cobra especial interés la Opinión Conjunta 2/2026 del Comité Europeo de Protección de Datos (EDPB) y del Supervisor Europeo de Protección de Datos (EDPS), adoptada el 10 de febrero, sobre la propuesta de Reglamento conocida como Digital Omnibus, publicada por la Comisión en noviembre de 2025. Su objetivo declarado es simplificar el marco legislativo digital, reducir cargas administrativas y reforzar la competitividad.

Sin embargo, el informe advierte de que algunos cambios podrían afectar negativamente al nivel de protección de las personas y desdibujar la seguridad jurídica. En primer lugar, muestra preocupación ante la modificación de la definición de “dato personal”. Según el EDPB y el EDPS, el nuevo enfoque podría estrechar el concepto y, con ello, reducir el ámbito de aplicación del Reglamento general de protección de datos (RGPD) y el nivel de protección de los individuos, sin que pueda considerarse una mera codificación de la jurisprudencia del Tribunal de Justicia de la Unión Europea. A su juicio, la reforma iría más allá de un ajuste técnico y podría incentivar a determinados responsables del tratamiento a intentar buscar lagunas para evitar la aplicación de la normativa de protección de datos.

En segundo lugar, el informe aborda la investigación científica con un tono más constructivo. Se valora positivamente la introducción de una definición armonizada de “investigación científica” y la clarificación de que el tratamiento ulterior con fines de investigación debe considerarse compatible con el propósito inicial, sin necesidad de aplicar las condiciones del artículo 6.4 del RGPD. Esta precisión puede aportar mayor claridad a hospitales, universidades y centros de investigación, especialmente en el ámbito de las ciencias de la salud, donde la reutilización de datos resulta esencial.

El texto también examina la introducción de una derogación parcial a la prohibición de tratar categorías especiales de datos, limitada a los supuestos en que el tratamiento de datos biométricos sea necesario para confirmar la identidad del interesado. No obstante, recuerda que incluso en estos casos deben respetarse estrictamente los principios de necesidad y proporcionalidad.

En definitiva, la Opinión Conjunta no cuestiona la conveniencia de simplificar, pero advierte de que simplificar no puede equivaler a desdibujar conceptos nucleares ni a debilitar derechos fundamentales. Resulta fundamental, pues, encontrar el debido equilibrio entre la necesidad de simplificar y el deber de no sobrepasar determinados umbrales de riesgo.

La entrada Entre la simplificación y el riesgo aparece primero en Faus Moliner.

En particular, la nueva Directiva permite a los tribunales ordenar al demandado la exhibición de documentos que puedan servir al demandante para justificar su reclamación, incluso aunque sean confidenciales, y presumir el carácter defectuoso del producto si el demandado no aporta los documentos cuya exhibición le haya sido requerida.

Asimismo, los tribunales podrán también presumir la existencia de un defecto, entre otros supuestos, si consideran que el producto no cumple con los requisitos de seguridad establecidos en la normativa aplicable; si consideran que el daño reclamado deriva de un mal funcionamiento evidente del producto durante su uso normal; o cuando consideren que el demandante ha demostrado que es probable que el producto sea defectuoso.

En la práctica, este nuevo marco normativo dará lugar a una inversión de la carga de la prueba, obligando a las empresas que reciban una reclamación de estas características a demostrar que su producto no es defectuoso.

A estos efectos, será especialmente relevante cumplir de forma ágil y diligente con cualquier requerimiento judicial de exhibición de documentos; aportar la documentación acreditativa de que el producto ha cumplido con todos los requisitos de seguridad que le exija la normativa; e incluso aportar pruebas sobre el correcto funcionamiento del producto en condiciones normales de uso y sobre su adecuada seguridad.

Por todo ello, conviene mantener de manera sistemática y organizada la documentación y los registros relativos al diseño y desarrollo del producto, ensayos de seguridad, procesos de fabricación y condiciones de almacenamiento y control de calidad; y la documentación completa y trazable del expediente del producto. Del mismo modo, contar con protocolos que faciliten cumplir con cualquier requerimiento de exhibición de documentos puede ser de gran utilidad.

Además, la Directiva amplía hasta los 25 años el plazo para reclamar por daños latentes que se manifiesten una vez transcurridos 10 años desde la puesta en el mercado del producto.

Todas estas novedades refuerzan la necesidad de contar con un sistema de gestión documental sólido y adaptado a las nuevas exigencias derivadas de este marco normativo, que permita aportar al procedimiento la documentación relevante para refutar las presunciones aplicables y acreditar que el producto puesto en el mercado no es defectuoso.

La entrada Archivo y prueba en la nueva Directiva de responsabilidad por producto aparece primero en Faus Moliner.

Bajo el Reglamento General de Protección de Datos (RGPD), los datos de salud se encuadran dentro de las categorías especiales de datos personales. En la actualidad, el debate ético y jurídico se sitúa en el uso secundario de los mismos. Mientras que el uso primario se define como la recogida de datos con fines asistenciales, el uso secundario consiste en su empleo para finalidades distintas a las originales, tales como la investigación científica o la salud pública.

En España, la Ley Orgánica de Protección de Datos, a través de su Disposición Adicional 17ª, fue pionera en permitir el uso secundario para fines de investigación científica, siempre que se apliquen garantías adecuadas como la seudonimización y la revisión por parte de un comité de ética. Con la próxima aplicación del Reglamento Europeo relativo al Espacio Europeo de Datos de Salud en marzo de 2027, se producirá un cambio profundo en las reglas para el acceso y uso secundario de datos de salud.

Justamente en el marco del primer Encuentro Nacional de Espacios de Datos, el Ministro para la Transformación Digital ha anunciado la puesta en marcha del Espacio Nacional de Datos de Salud, la adaptación en España del Espacio Europeo de Datos de Salud, como si de una realidad ya tangible se tratara. No obstante, la realidad es que la ley que adaptará nuestro ordenamiento al Espacio Europeo de Datos de Salud se encuentra todavía en tramitación: el anteproyecto de la Ley de Salud Digital se sometió a consulta pública el pasado mes de septiembre, por lo que existen aún interrogantes sobre cómo se garantizará la confidencialidad de los datos y cómo se articulará la gobernanza del sistema en un Estado descentralizado como el nuestro. Por este motivo, conviene mantener la prudencia, evitando proyectar expectativas que aún deben definirse en la futura Ley de Salud Digital.

En último término, el Día de la Protección de Datos debería servir de reflexión especialmente para el legislador. Siendo indiscutible el valor estratégico de los datos de salud, una de las claves para la implementación del Espacio Nacional de Datos de Salud será garantizar que todo acceso a la información se someta siempre a medidas adecuadas de protección. Todo ello bajo la supervisión de organismos de acceso que cuenten con expertos en bioética y protección de datos, y sin olvidar que la materia prima de la que se nutrirá este ecosistema serán los datos de salud de las personas.

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Clinical investigations with medical devices are governed by Regulation (EU) 2017/745 (MDR), Royal Decree 192/2023 and Royal Decree 1090/2015. Performance studies with IVDs are governed by Regulation (EU) 2017/746 (IVDR) and Royal Decree 1662/2000, until the new Royal Decree currently under preparation is approved.

As happened previously with Regulation (EU) 536/2014 and Royal Decree 1090/2015 on clinical trials with medicinal products, the Spanish Medicines Agency (AEMPS) published a memorandum in July to clarify the applicable regulatory framework for clinical investigations involving medical devices.

In particular, the memorandum explains the roles of AEMPS and the Research Ethics Committees for Medicines (CEIm), and sets out the obligations and responsibilities of sponsors across the different types of clinical investigations with medical devices and IVD performance studies. Based on the experience gained over the past few months, we highlight below the aspects we consider most relevant.

Pathways depending on the type of study

If the investigation involves a medical device without CE marking, or a CE-marked device used outside its intended purpose as described by the manufacturer in the instructions for use, AEMPS authorisation is required.

By contrast, if the investigation requires participants to undergo additional procedures beyond those used under normal conditions of use, and these are invasive or burdensome, the study must be notified to AEMPS, but authorisation is not required.

Finally, where the medical device is CE-marked, is used in line with its intended purpose and instructions for use, does not involve invasive or burdensome procedures, and the purpose of the study is not to assess device conformity, neither authorisation nor notification to AEMPS is required.

In all cases, it is mandatory to obtain a favourable opinion from an accredited CEIm, which will be single and binding for all participating sites. In addition, approval from the management of each site is required, usually formalised through the relevant agreement.

For IVD performance studies, the pathways are similar. For studies involving companion diagnostics, AEMPS clarifies that where only leftover samples are used and no therapeutic decisions or patient selection decisions are made, it is sufficient to notify the competent authority. In Spain, in the absence of Eudamed, this is processed through the NEOPS database.

Compensation and insurance

Clinical investigations intended to assess the conformity of non-CE-marked medical devices (or CE-marked devices used outside their intended purpose within the conformity assessment process) require insurance coverage.

By contrast, insurance is not required for investigations involving CE-marked medical devices used within their intended purpose.

For IVD performance studies, insurance is required where the investigational device does not have CE marking, or where it does have CE marking but is used outside its intended purpose.

Combined trials

Combined trials are studies where an investigational medicinal product is assessed at the same time with a non-CE-marked medical device, or a CE-marked device used outside its intended purpose.

In these cases, the relevant authorisations must be requested in parallel. Documentation for the medicinal product trial must be submitted through CTIS(Clinical Trial Information System), while documentation for the device investigation must be submitted—until the European database Eudamed becomes operational—via the AEMPS General Registry, addressed to the Medical Devices Department.

The same CEIm will assess both parts of the study. The sponsor must submit a single patient information sheet for review.

Informed consent

The AEMPS memorandum also specifies the format, maximum length, and the mandatory content that must be included in the patient information sheet and informed consent form for participants in medical device investigations, which must in all cases be approved by the CEIm.

These requirements are very similar to those set out in Annex VIIIA (Guidance for the correct preparation of a patient information sheet and informed consent form + Appendix on personal data protection) and Annex VIIIB (Text to be included in informed consent for the collection and use of biological samples in clinical trials), previously published by AEMPS as part of its instructions for conducting clinical trials with medicinal products in Spain.

As a new requirement, AEMPS states that for investigations involving medical devices with artificial intelligence systems, participants must be informed about the use of this technology. Specifically, the consent document must indicate whether the output will be used for clinical decision-making, diagnosis, prognosis, or medical care, or whether the results are exploratory or preliminary.

Participants must also be informed of the risks associated with the use of artificial intelligence, such as system errors (i.e. incorrect outputs), the risk of discrimination, and the potential existence of bias.

La entrada Practical considerations for clinical investigations with medical devices in Spain aparece primero en Faus Moliner.

In December 2020, the European Commission granted a conditional marketing authorisation for Comirnaty®, which required the marketing authorisation holder (BioNTech) to provide additional data on the characterisation of the active substance and the finished product.

In 2021, a citizen requested access to this information from the European Medicines Agency (EMA). The EMA granted partial access, but withheld certain technical data to protect BioNTech’s commercial interests.

The applicant challenged this decision before the General Court of the European Union (GCEU), which was called upon to determine whether there was an overriding public interest justifying disclosure of the redacted information.

Nature of the redacted information

Before examining whether an overriding public interest existed, the GCEU first analysed the nature of the redacted information. It consisted of trial results relating to the characterisation of the active ingredient and the finished product, as well as the technical parameters used to conduct those trials. This was therefore highly technical information, derived from BioNTech’s specific scientific know-how.

The EMA argued that, given the innovative nature of the technology, its disclosure would enable competitors operating in the same therapeutic field to save scientific effort and human and economic resources.

The GCEU accepts this reasoning and concludes that the redacted data constitutes commercially sensitive information, the disclosure of which could harm BioNTech’s commercial interests. Furthermore, the Court recalls that Regulation (EC) No 1049/2001 on public access to documents does not require the harm to be quantified, nor does it require a detailed market analysis to assess it. It is sufficient that the risk of harm be reasonably foreseeable and not merely hypothetical, unless an overriding public interest justifies disclosure.

What about the public interest?

Having confirmed the commercially sensitive nature of the information, the GCEU turned to the question of whether an overriding public interest nevertheless justified disclosure.

The Court is clear on this point: where access to documents is refused by the public authority, it is for the applicant to demonstrate the existence of such an overriding public interest. A general invocation is insufficient. The applicant must demonstrate, in concrete terms, that disclosure specifically contributes to protecting the public interest. Accordingly, public authorities are not required to assess ex officio whether such an overriding public interest exists.

In the present case, the Court agrees with the EMA that the redacted information was limited in scope, and strictly technical, and likely to benefit BioNTech’s competitors if disclosed. Granting access would therefore upset the balance struck by the European legislation between companies’ obligation to provide sensitive information to the EMA and the strong protection given to that information under professional and commercial secrecy.

What happens if the information has already been leaked?

Directive (EU) 2016/943 and Spanish Law 1/2019 on Trade Secrets define a trade secret as information that is secret, that has commercial value precisely because it is secret, and that has been subject to reasonable measures by its owner to keep it secret.

This classification allows access to be refused where disclosure would cause economic harm to its owner.

In this context, the question arises as to what happens if such secret information is leaked.

In this case, part of the redacted information had been disseminated online following a cyberattack on the EMA. The Court examines whether such a leak altered the legal assessment.

The Court’s response is unequivocal: unauthorised disclosure does not automatically render that information publicly accessible for the purposes of the rules on freedom of information and access to public documents.

Conclusions

Three main conclusions can be drawn from this Judgment:

First, no quantification of harm is required. It is sufficient that the risk to commercial interests be reasonably foreseeable. This issue remains controversial at national level, for example in relation to access to pricing and reimbursement decisions.
Second, public authorities are not required to assess ex officio whether an overriding public interest exists. The burden of proof lies with the applicant who has been denied access to specific information.

Third, a leak or unauthorised disclosure of part of the requested information does not prevent the remaining information from continuing to merit protection.

La entrada Trade secrets and transparency: how far does the public interest extend? aparece primero en Faus Moliner.

Limited access to Joint Scientific Consultations (JSCs)

The first challenge concerns Joint Scientific Consultations (JSCs). These consultations, similar to the EMA’s scientific advice, are intended to allow companies to obtain early guidance on clinical trials design and align evidence generation with joint assessment requirements. JSCs are already operational and provide a unique forum for dialogue with HTA authorities, which may prove decisive for a medicinal product’s development strategy.

However, access to these consultations is limited. After only one year, it has become apparent that capacity constraints means that not all companies can benefit from them. In practice, access may depend more on available resources than on scientific or clinical criteria. From a legal perspective, this poses a challenge in terms of fairness: Article 41 of the Charter of Fundamental Rights of the EU (CFR) guarantees the right to good administration, including equal treatment and non-discrimination. If access to JSCs is restricted for resources constraints, questions arise as to how fair access of companies can be ensured, particularly when such consultations may strongly influence development strategies.

Lack of predictability around the definition of PICOs

Another key issue concerns the definition of PICOs (Population, Intervention, Comparator and Outcomes) in Joint Clinical Assessments (JCAs). Member States may propose multiple PICOs, which creates uncertainty regarding the scope of the assessment and how to organise the generation of evidence.

This is particularly problematic when comparators include off-label uses or interventions that differ significantly from those being evaluated. According to the HTA Coordination Group’s Guidance on the Scoping Process (13 November 2024), comparators may include unauthorised treatments or non-pharmacological interventions. A single PICO could end up facing alternatives with very different regulatory realities and development plans; for example, an industrially manufactured product and a magistral formula. This not only complicates the preparation of evidence, but also creates an incentive challenge: an authorised, industrially developed medicinal product will have borne the full costs and requirements of the entire regulatory process, whereas an off-label comparator or magistral formula may not have undergone the same level of development.

From a legal standpoint, this lack of predictability affects legal certainty and undermines companies’ ability to plan clinical evidence and launch strategies. Ensuring that PICOs are proportionate and reasonable is therefore essential to comply with the principles of good administration under Article 41 CFR.

Further uncertainty arises from the strict procedural timelines under the HTA Regulation. The 100-day deadline for preparing HTA dossiers is particularly challenging, as it depends on the timing of EMA procedures and may change unexpectedly.

This creates compliance risks, especially for small and medium-sized companies with limited regulatory capacity. The problem is compounded by the possibility that several PICOs may apply to a single product and by the lack of clarity regarding the consequences of submitting an incomplete dossier or failing to submit one at all.

Together, these factors increase legal uncertainty and highlight the need for careful planning.

Conflicts of interest

The European HTA system relies on highly specialised experts to carry out JCA. However, the more innovative the technology (such as ARMPs or orphan medicinal products), the smaller the pool of available experts and the greater the likelihood of conflicts of interest. Regulation (EU) 2021/2282 acknowledges the challenge of reconciling the requirement for impartial procedures with the need to preserve the scientific rigour and technical depth of assessments that demand an exceptionally high level of expertise.

Implementing Regulation 2024/2745 adopts a pragmatic approach, allowing experts with conflicts of interest to participate in exceptional cases where no viable alternative exists, provided strict transparency and risk-mitigation measures are applied. This solution reflects a significant shift in the legal debate: conflicts of interest are no longer conceived as a binary category (existing or non-existent) but as a factor to be managed in light of the overall public interest and the need for high-quality scientific input. Experience to date confirms that the real challenge lies in balancing independence, expertise and legal certainty in an increasingly demanding regulatory environment.

The limited role of the developers in the HTA Process

The procedural design of Regulation (EU) 2021/2282 assigns the developer a particularly restricted role at key stages of the JCAs. At the scoping stage, Article 8.6 of the HTA Regulation expressly excludes health technology developers from defining the PICO parameters, which are constructed primarily on the basis of extracts from the dossier submitted to the EMA and contributions from Member States. Unlike patients and clinical experts, developers are not granted a formal channel for providing substantive comments on the scope of the assessment, despite this being a determining factor in the outcome of the HTA.

This limited position is maintained in subsequent stages of the procedure. The scoping clarification meetings provided for in Implementing Regulation (EU) 2024/1381 are purely explanatory in nature and do not allow the developer to influence the content of the scope, in addition to being optional. Likewise, the Implementing Regulation restricts the developer’s right to comment on the draft JCA report to the identification of factual or technical errors, with particularly short review deadlines.

These restrictions raise an important legal question: is the procedure for preparing a JCA compatible with the right to be heard and the right to good administration enshrined in Article 41 of the CFR? Although the answer is nuanced, it is clear that the Regulation does not grant the developer the weight it ought to have in the process, thereby missing the opportunity to make the most of the direct knowledge of those who know the product best.

Although the company has its own interest in the assessment, this should not be used to restrict its participation at various stages. The real challenge, as noted in the section on conflicts of interest, is to recognise and manage this conflict in a balanced manner, rather than using it as an argument to reduce the developer’s participation.

Uncertainty regarding the use of JCAs in national procedures

A further question raised by Regulation (EU) 2021/2282 concerns how the relationship between JCAs and national assessment and decision-making procedures will be structured in practice. The Regulation itself adopts a deliberately ambivalent formulation: on the one hand, JCAs are expressly non-binding and “should therefore not affect the discretion of Member States to carry out assessments on the clinical added value of the health technologies concerned” (recital 14); on the other hand, Member States are required to “give due consideration” to these reports and to attach them to their national assessments, also informing the Coordination Group of how they have been used (Articles 13 and 14 of the Regulation). This combination of formal non-binding nature and obligation to take them into account leaves ample room for divergent reinterpretations at national level, with the consequent risk of fragmentation.

In the case of Spain, this uncertainty is amplified by the decentralised structure of the National Health System itself. Although the Ministry of Health has expressed its intention to respect joint clinical assessments developed at European level, the current legal framework allows JCAs to be integrated into complex national processes, involving multiple authorities and decision-making levels, and in which additional assessments or successive re-evaluations cannot be ruled out (e.g. at the level of the Autonomous Communities or even at hospital level). All this takes place in an area – the allocation of resources for national health systems and pricing and reimbursement decisions – that EU primary law reserves to the Member States (Article 168 TFEU). The question therefore remains open as to whether the new system will succeed in reducing duplication of clinical assessments and achieving genuine harmonisation, or whether national application of JCAs will ultimately reproduce, in new forms, the divergences the Regulation seeks to address.

Conclusions

One year after the launch of European HTA, the legal and procedural challenges are evident: limited access to JSCs, uncertain PICOs, off-label comparators, tight deadlines and restricted developer participation. This compels companies to plan strategically, combining science and law from the earliest stages.

Added to this is national-level development. The Royal Decree on Health Technology Assessment, which will regulate the national stage, is at an advanced stage of preparation and was submitted o the Council of State for revision this month. It is expected to be approved soon by the Council of Ministers. The new Law on Medicinal Products and Medical Devices, on the other hand, remains subject to an uncertain legislative timetable. These national regulations will complete the European framework and shape the next phase of adaptation for companies.

The first year delivers a clear message: European HTA is not only a technical challenge, but also a strategic and legal one. Those able to anticipate developments and act with flexibility will be better positioned to demonstrate the value of their technologies and remain competitive in an increasingly demanding market. Close attention to national developments will be essential to finalise the regulatory framework and support informed decision-making.

La entrada The HTA Regulation: one year on aparece primero en Faus Moliner.

Voluntary withdrawal does not imply that the product is defective

One of the first points made by the Court is that the mere voluntary withdrawal of a product from the market does not, in itself, constitute proof of its defective nature.

Safety measures such as the withdrawal of the product by a regulatory authority or by the company responsible may be taken into account by the court when assessing whether a product is defective. However, these actions should not, on their own, give rise to an automatic presumption of defectiveness. Their assessment must always be made in conjunction with the other circumstances and evidence of the specific case.

The existence of judicial precedents concerning the product

The Court also recalls that, when deciding on the alleged defective nature of a product, other judicial proceedings are not conclusive, even if they concern the same product.

Although precedents may be taken into account as one factor in the overall analysis, they do not by themselves determine whether the product is defective. Each proceeding must be resolved based solely on the evidence presented in that specific case and on the litigation strategy followed by each party.

In this regard, the Court emphasises that only evidence that is included in the case file and has been validly submitted within the framework of the proceedings in question is relevant.

The importance of clarifying that the product’s failure was not due to a defect

Finally, it is worth highlighting an additional consideration that emerges from the Judgment: the importance of identifying possible causes other than the alleged defect that may have contributed to or caused the damage claimed.

In this case, the Court considers that if it is not possible to clearly determine the cause of the damage, or reasonably rule out other explanations, the product may be considered defective by resorting to indirect evidence or even presumptions.

Conversely, if it can be demonstrated that the damage was caused by external factors unrelated to the product’s design or manufacture – such as incorrect use, improper handling, or lack of maintenance – such presumptions of defectiveness may be rebutted.

Evidentiary challenges and the impact of the new Directive

Overall, the Judgment underscores the central role of evidence in product liability claims.

As noted, the deadline for transposing the new Product Liability Directive expires at the end of this year, introducing significant changes to the evidentiary framework and the allocation of the burden of proof.

In order to assist claimants in proving their case, the new Directive establishes a number of evidentiary rules that must be carefully considered and that make it advisable for companies to adopt measures aimed at avoiding presumptions of defectiveness.

The new Directive allows courts to order the defendant to disclose relevant documents – even confidential ones – to enable the claimant to substantiate their case. If the defendant fails to comply with such a disclosure order, a presumption that the product is defective may arise.

Furthermore, courts may presume defectiveness in three additional situations:

i. where the product fails to comply with applicable safety requirements;

ii. where the damage results from an obvious malfunction during normal use; or

iii. where, considering all relevant circumstances, the claimant faces excessive difficulties due to technical or scientific complexity in proving the defectiveness of the product, or provided the claimant demonstrates that it is likely that the product is defective.

These rules may, in practice, lead to a partial reversal of the burden of proof, requiring manufacturers and suppliers to demonstrate that their product was not defective. This makes it essential to comply with any court-ordered disclosure, to maintain documentation evidencing regulatory compliance, and, where appropriate, to provide evidence of the product’s proper functioning under normal conditions.
For all these reasons, it is advisable to maintain documentation and records relating to product design and development, safety testing, manufacturing processes, storage conditions and quality control in a systematic and organized manner, as well as complete and traceable product file documentation. In addition, having protocols that facilitate compliance with any document disclosure request may be highly useful.

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La entrada La promoción de oficinas de farmacia a la luz del derecho de la unión aparece primero en Faus Moliner.

El nuevo programa no parte de cero. Es la continuación natural del PERTE Salud de Vanguardia aprobado en 2021 en el marco del Plan de Recuperación, que en abril del año pasado ya había movilizado cerca de 2.500 millones de euros y alcanzado un grado de ejecución superior al 80% de la inversión pública prevista, según informó el Ministerio de Sanidad. El reto ahora es consolidar y escalar.

Desde el punto de vista de contenidos, el programa 2025-2027 se articula en torno a objetivos estratégicos y objetivos transversales.

Los objetivos estratégicos tienen conexión con el PERTE inicialmente aprobado, pero persiguen ampliar el ámbito de actuación, incorporar necesidades no cubiertas y generar mayor alineamiento con el marco estratégico europeo e internacional.

El primero de estos objetivos, seguir impulsando abordajes innovadores de medicina 5P (predictiva, preventiva, personalizada, participativa y poblacional), basada en el uso intensivo de datos clínicos, genómicos y poblacionales, incluye acciones como involucrar a ciudadanos y pacientes desde fases tempranas y crear el espacio de datos IMPaCT con información de los proyectos de medicina de precisión del PERTE.

El segundo objetivo, promover el desarrollo y fabricación en España de productos biotecnológicos, tecnología sanitaria innovadora y medicamentos innovadores, incluye la previsión de un plan estratégico de terapias digitales innovadoras, que contemple expresamente su escalado y certificación.

El tercer objetivo es favorecer el desarrollo e implementación de servicios sanitarios digitales e impulsar los espacios de datos, la IA y la analítica de datos relacionados con la salud en condiciones de ciberseguridad. Entre las actuaciones encontramos medidas encaminadas a financiar la generación y transferencia de conocimiento en salud digital, la creación y uso secundario del Espacio Nacional de Datos de Salud del SNS y otros Espacios de Datos o el apoyo al sandbox regulatorio en IA.

Por último, el cuarto eje persigue la incorporación de innovación tecnológica y digital orientada a la preparación y respuesta frente a amenazas globales y refuerzo de la seguridad, y aborda ámbitos como las terapias antimicrobianas o las emergencias graves para la salud pública.

Por su parte, los objetivos transversales se orientan a la mejora de las capacidades y estructuras en el sistema de I+D+I y digitalización. Estos objetivos incluyen, por ejemplo, el fortalecimiento del I+D+I en el ámbito asistencial, el impulso a la equidad o el refuerzo del liderazgo internacional.

Con la definición de un marco ambicioso, el próximo paso es convertir esta ambición en resultados tangibles y sostenibles. La salud de vanguardia del futuro ya está aquí.

La entrada La salud de vanguardia del futuro ya está en marcha aparece primero en Faus Moliner.

El nuevo programa no parte de cero. Es la continuación natural del PERTE Salud de Vanguardia aprobado en 2021 en el marco del Plan de Recuperación, que en abril del año pasado ya había movilizado cerca de 2.500 millones de euros y alcanzado un grado de ejecución superior al 80% de la inversión pública prevista, según informó el Ministerio de Sanidad. El reto ahora es consolidar y escalar.

Desde el punto de vista de contenidos, el programa 2025-2027 se articula en torno a objetivos estratégicos y objetivos transversales.

Los objetivos estratégicos tienen conexión con el PERTE inicialmente aprobado, pero persiguen ampliar el ámbito de actuación, incorporar necesidades no cubiertas y generar mayor alineamiento con el marco estratégico europeo e internacional.

El primero de estos objetivos, seguir impulsando abordajes innovadores de medicina 5P (predictiva, preventiva, personalizada, participativa y poblacional), basada en el uso intensivo de datos clínicos, genómicos y poblacionales, incluye acciones como involucrar a ciudadanos y pacientes desde fases tempranas y crear el espacio de datos IMPaCT con información de los proyectos de medicina de precisión del PERTE.

El segundo objetivo, promover el desarrollo y fabricación en España de productos biotecnológicos, tecnología sanitaria innovadora y medicamentos innovadores, incluye la previsión de un plan estratégico de terapias digitales innovadoras, que contemple expresamente su escalado y certificación.

El tercer objetivo es favorecer el desarrollo e implementación de servicios sanitarios digitales e impulsar los espacios de datos, la IA y la analítica de datos relacionados con la salud en condiciones de ciberseguridad. Entre las actuaciones encontramos medidas encaminadas a financiar la generación y transferencia de conocimiento en salud digital, la creación y uso secundario del Espacio Nacional de Datos de Salud del SNS y otros Espacios de Datos o el apoyo al sandbox regulatorio en IA.

Por último, el cuarto eje persigue la incorporación de innovación tecnológica y digital orientada a la preparación y respuesta frente a amenazas globales y refuerzo de la seguridad, y aborda ámbitos como las terapias antimicrobianas o las emergencias graves para la salud pública.

Por su parte, los objetivos transversales se orientan a la mejora de las capacidades y estructuras en el sistema de I+D+I y digitalización. Estos objetivos incluyen, por ejemplo, el fortalecimiento del I+D+I en el ámbito asistencial, el impulso a la equidad o el refuerzo del liderazgo internacional.

Con la definición de un marco ambicioso, el próximo paso es convertir esta ambición en resultados tangibles y sostenibles. La salud de vanguardia del futuro ya está aquí.

La entrada La salud de vanguardia del futuro ya está en marcha aparece primero en Faus Moliner.