The speed and relevance of assessing health products

5 Oct
Emmanuel Giménez

The European market of health products has been widely affected by the sudden emergence of a new legislative framework with the new regulations (2017/745 and 2017/746). The subtle difference between directive and regulation is paramount, they say, but we’ll leave that for another occasion. This new framework in the field of health products is characterised among other things by:

  1. A stricter control of high risk health products (for example, certain implantable products)
  2. The strengthening of rules of clinical evidence by including a coordinated procedure at a European level for the authorisation of multicentre clinical research.
  3. The reinforcement of requirements and the coordination between European countries regarding controls and after sales aspects.

In this context of important changes, the assessment community is also clearly active. Thus, on 19 June this year, there was a panel on health products at the international meeting of Health Technology Assessment HTAi, where a new and innovative Italian programme for health products was presented.

The programme, explaining the work carried out over several years in terms of definition and its pilot phase, includes three work packages: appraisal, methodology and monitoring. In another panel closely related to the previous one, in the field of methodology, the presentation of the categories to decide on what to invest in and what to disinvest win clearly stood out.

When talking about monitoring and collecting information, an example that stood out was the debate on the need for early assessments given that the life cycle of a health product tends to be short.

The significant increase in new products available and all the work objects previously mentioned are some of the things that position the importance of specific assessment in health products.

The importance of the assessment of health products is, therefore, undeniable. In the joint production work package of EUnetHTA JA3, in which AQuAS is participating, as many or more assessments of “other technologies” (health products, health interventions,…) have been planned as of the known assessments of drugs. In a sense, the numbers of one or other necessity are matched. The importance of the assessment of “other technologies” was in fact reflected in the HTAi annual meeting in a presentation by Wim Goettsch, director of EUnetHA.

The identification and prioritisation of products to be assessed (the Horizon Scanning system), as well as the balance between innovation and divestment, are also extensively discussed subjects and under continuous debate. Thus, in the REDETS network (in which the AQuAS is also actively participating) and with the leadership of Avalia-T, a public access tool was identified that helps in approaching this subject: the PriTec.

Assessment, therefore, can help directly in the use, management and sustainability of different health systems. In conclusion, new opportunities are provided for improving decision making in the area of health products and some of them will come through demonstrating efficiency by means of the adequate use and definition of health technology assessments (HTA).

Post written by Emmanuel Giménez.

The main challenge in mHealth is understanding each other

3 Mar
Toni Dedéu - DECIPHER final event 2017
Toni Dedéu

In recent years, the debate about what we should do with health apps has centred around accreditation, certification or assessment. At the same time, multiple lists of health apps recommended by a range of known and recognised initiatives have been drawn up.

An example of this would be the iSYScore2017 ranking of the Fundació iSYS which was presented in the context of the CAMFiC a few weeks ago.

rànquing apps salut

In this context, and with the Mobile World Congress 2017 in Barcelona in full swing, we can ask ourselves what role a Health Technology Assessment (HTA) agency has when considering mHealth.

There is a reality which we cannot evade. Any health intervention needs to be based on evidence, on knowledge of the highest quality at hand, and must be evaluated.

This cannot be done by turning our backs on the real world or innovation. A health app is a tool to carry out a health intervention and so health apps need to be seen as just another intervention, but of course, with some characteristics of their own which will mean there is an extra demand placed on one and all.

Technologists, HTA experts, professionals and citizens have the opportunity to understand each other if we want to be facilitators of recommending safe apps in health. We are not talking about initiatives that can be developed from one sector only and it is not only about apps.

Now more than ever, we need to be flexible and work from a multidisciplinary position. We already talk about co-creation and co-design; quite simply, of co-produced mHealth initiatives based on the expertise of multiple agents including, obviously, citizens.

AQuAS is participating in the assessment of several mHealth projects financed by the European Commission. The PEGASO project stands out, centred on promoting healthy lifestyles among adolescents, and DECIPHER, as an integral solution to facilitate the geographical mobility of patients with chronic diseases such as diabetes type 2 and m-resist, centred on schizophrenia and patients resistant to treatment.

We are faced with the challenge of integrating totally different fields such as the language of technologists and developers; the speed of innovation and the culture of assessment. In addition, this needs to be done without losing sight of the key role of scientific societies and the different points of view of health professionals and end users.

We know there is a lot of work to be done. Technologists and experts in health technology assessment, respectively, have the opportunity to learn a lot from each other. It is about sharing knowledge and expertise to facilitate, ultimately, health tools for citizens and professionals, which have been assessed, are based on evidence, are safe and reliable and have a strong collaborative component.

Digital Health and Wellness Summit – MWC17


Post written by Toni Dedéu (@Toni_Dedéu) and Elisa Puigdomènech.

Health data: Do we give citizens what they want?

24 Nov
Dolores Ruiz-Muñoz, Anna García-Altés and Hortènsia Aguado

The right to receive advice with regards to the information available on the network is reflected in the Carta de drets i deures de la ciutadania en relació a la salut i l’atenció sanitària (Citizens Bill of Rights and Duties relating to health and healthcare), updated in 2015. In particular, it specifies that a person has the right to obtain accurate and reliable recommendations from health professionals in terms of the available health information on the network (web pages, applications, etc…).

It is a fact that, from different professional sectors, we are more and more frequently identifying citizens as a key group to take into consideration when communicating the outcomes of our work, including the health sector. The different actors involved in disseminating health information resulting from the Catalan health system activity are no exception. When we publish our data we do it more and more in a way that is not only aimed at informing health professionals on the one hand but also at being accountable to citizens as end users.

But have we really asked citizens what information they want to obtain from us?

From the Results Centre of the Catalan Health System Observatory we publish a series of reports annually with quantitative indicators that aim to measure, assess and disseminate the results obtained in the different areas of the public health system. Up to the present, to disseminate this information beyond the comfort zone of the health sector, we have published a series of infographics with the information that we have considered to be most relevant for citizens, making the effort to create a user friendly format.



During the first semester of 2016, we spent time reflecting on our labour and we realised that we did not in fact know whether what we were publishing for citizens really reached or interested them. We did not even know what it was that citizens wanted to receive from us. To answer these questions we carried out a qualitative study of Catalan citizens to find out what their needs for health information were, but not limiting ourselves to that produced by the Results Centre.

We created three discussion groups and invited citizens randomly selected from Registre Central d’Assegurats del CatSalut (CatSalut’s Central Registry of the Insured) to freely express what they felt their necessities for health information were. What we discovered was that the population is not interested in receiving health information in a general or systematic way but rather only wants health information when they have a specific personal need and which is directly related to what is affecting them at a given time. They are not interested, therefore, in receiving health information about the population as a whole nor of how the health system works. They state that this information is necessary but feel it is health professionals who need to have it and know how to manage it. In this way, they place their trust in the health system by dissociating themselves from this type of information.

Furthermore, they consider it of interest that the information be made available on the networks but state that, whether they actively search for it on the internet or not, what they need is to be able to contrast the information at a later stage with their primary care physician or specialist, and that it be this professional who discerns what the best information available is for each occasion. What is more, they clearly identify this professional as being the person who needs to know the health information produced systematically by the Catalan health system.

We presented the results of this study at a recent congress, to be exact, the XXXIV Congress of the Spanish Society for the Quality of Healthcare and the XXI Congress of the Andalusian Society for the Quality of Healthcare, generating a very interesting posterior debate regarding these results. One of the attendees at the congress stated their concern for the fact that citizens were not interested in receiving general health information. The debate centred on how we could educate the population into showing an interest in this information and on how to make it reach them. We believe that the key underlying question here is whether this need be done at all.

The public at large have an overwhelming amount of information at their disposal on an infinite number of different subjects on a daily basis. It seems clear that when a person has a specific need regarding their state of health they consult a professional in whom they trust. It is obvious that to us, as healthcare professionals, we will always feel that the information we produce is of such interest as to make others want to know about it, but it is also probable that our enthusiasm makes us biased when interpreting reality. We should perhaps ask ourselves whether we need to make the effort to provide the public with information they say they do not need nor interests them, and whether we are prepared to accept their decision and respect it.

Post written by Dolores Ruiz-Muñoz, Anna García-Altés and Hortènsia Aguado.