Working Towards Legitimacy in Decision Making: on ogoverning appropriate medicine use and reimbursement in health care

In the last three decades governmental policy in prioritization of medicines is increasingly legitimized through the scientization of the decision-making process on the one hand and a separation in policy production and policy execution on the other. The discourse on health care reimbursement decisions has likewise been dominated by increased rationalization and formalization of the decision-making process. Since the early 1990s the Dutch government and arm’s length agencies have undertaken much effort to regulate pharmaceutical care, mainly by emphasizing the role evidence should have in decision-making on the appropriate use of medicines at all levels, from decisions on insurance schemes coverage to prescriptions at the point of care (Commissie Dunning 1991; Gezondheidsraad 1991; College voor zorgverzekeringen 2007). The Dutch government has developed a series of tools to promote rational prescribing – such as professional guidelines authorized by state agencies, real-time monitoring systems and the conditional reimbursement of medicines – aimed at improving the quality and efficiency of care, and enabling the control of pharmaceutical health care expenditure (College voor zorgverzekeringen 2005; Niezen et al. 2007). Despite the rationalisation of decision-making, governmental policymakers still experience difficulties in explaining the foundations for their decisions. Moreover, the execution of the health regulations in daily practice appears to deviate substantially from the intended policy and its underlying principles (Niezen et al. 2007). The Dutch drug reimbursement system is based on a bureaucratic system logic; if rational decision criteria are used, consistent and legitimate decisionmaking has taken place. The definition of formulary lists (medicines eligible for funding) presumes that appropriate medicine use and reimbursement not only can be defined, but subsequently can be implemented in health care provision. Thus, when health care providers prescribe medicines according to the national formulary, appropriate drug use is warranted. However, there is a discrepancy between the decision-making process outcomes and actual practice of medicine prescription and reimbursement. This discrepancy points at potential legitimacy problems which require further research. What work practices can be observed that are supposed to lead to (more) legitimate decision-making? And, if legitimate decision-making can be observed, how does that wear off in clinical practice? Increasing the legitimacy of prioritization decisions might decrease the difference between policy and practice. Making use of a social scientific perspective this thesis analyses the (development of the) infrastructure of the Dutch drug reimbursement decision-making process and health care allocation instruments in order to gain insight in the practice of health care prioritization decision-making and the way this is legitimized

Leren van toezicht

Toezicht staat onder immer toenemende belangstelling, of het nu gaat om het toezicht op financiële instellingen, de veiligheid van het vliegverkeer of de gezondheidszorg. De oorzaken hiervan zijn divers maar kunnen deels gevonden worden in het terugtreden van de overheid als uitvoerder van publieke diensten. Om controle te kunnen houden op die diensten zijn de afgelopen decennia grote toezichthoudende organen opgericht, die inmiddels een flink deel van de economie beslaan; volgens sommige berekeningen werken momenteel ongeveer een miljoen mensen in de ‘toezichtsindustrie’ (van Waarden 2006). Daarnaast dringt steeds meer het besef door dat we leven in een ‘risicomaatschappij’ (Beck 1992) die, hoe paradoxaal ook, aanleiding heeft gegeven tot een ‘veiligheidsutopie’ (Boutelier 2002). Risico’s worden steeds minder geaccepteerd en overheden en toezichthouders worden daar in toenemende mate op aangesproken. Deze trend brengt met zich mee dat onderzoek naar het functioneren van toezichthouders sterk in maatschappelijk belang heeft gewonnen. De afgelopen jaren is dan ook internationaal te constateren dat dit onderzoek een hoge vlucht heeft genomen. Ook de inspecties zelf hebben inmiddels onderzoeksprogramma’s opgezet. Dit geldt ook voor de Inspectie voor de Gezondheidszorg (IGZ). Het voorliggende rapport is een verslag van onderzoek naar de effectiviteit van een van de belangrijke toezichtsinstrumenten van de IGZ, het zogeheten Thematisch Toezicht. Middels casestudie onderzoek beoogt dit rapport de vraag te beantwoorden op welke manier het thematisch toezicht effectief kan zijn en voor welk type risicoproblemen deze vorm van toezicht het meest geschikt is. Hiermee probeert het rapport een zowel conceptuele als empirische bijdrage te leveren aan de discussie over het toezicht in algemene zin, en in het bijzonder over het toezicht op en in de gezondheidszorg

D:A4.1 Socio-economic impact assessment

The executive summary ends with six concise recommendations for facilitating more accountability for data management in cloud ecosystems: 1. Provide a stronger legal base for and enforcement of data protection and accountable behavior; 2. Facilitate independent auditing of responsible data stewardship; 3. Increase public awareness of the need for accountability; 4. Balance existing information asymmetries via partnerships; 5. Focus on larger enterprises working in the public sector first, as these can serve as an example for other types of businesses; 6. Demonstrate how A4Cloud tools and mechanisms can be turned into a business model in order to encourage greater uptake and use

Unobtrusiveness in mHealth design and use: A systematic literature study

mHealth still is an emerging and rapidly developing field of study. mHealth promises to increase access to care at lower costs and with greater acceptance. The increased acceptance of mHealth is often related to the diminished obtrusiveness of the device monitoring, coaching, diagnosing, and / or collecting data of its user. However, such ‘unobtrusiveness’ not only has gains, but might also come at a cost. This paper focuses on how obtrusiveness currently plays a role in the design and use of mHealth, and what social and ethical implications are associated with this role. To gain such understanding a literature review of PubMed and Web of Science was performed. Discourse analysis is used to study the identified themes in the review and the introduction of unobtrusiveness in mHealth. This analysis demonstrates a tension between the modernist discourse and the humanist discourse, since both discourses articulate obtrusiveness in a different way. While unobtrusiveness seems desirable from a users’ acceptance and design perspective, mHealth that is designed to be unobtrusive does have reported social and ethical implications. The developers and designers of future mHealth services should be aware of these implications. Users should be informed about the trade-off they make between unobtrusive monitoring or coaching via mHealth and potential infringement of privacy, loss of autonomy and will-power