Big Data and Health Research —The Governance Challenges in a Mixed Data Economy
AbstractDenmark is a society that has already moved towards Big Data and a Learning Health Care System. Data from routine healthcare has been registered centrally for years, there is a nationwide tissue bank, and there are numerous other available registries about education, employment, housing, pollution, etcetera. This has allowed Danish researchers to study the link between exposures, genetics and diseases in a large population. This use of public registries for scientific research has been relatively uncontroversial and has been supported by facilitative regulation that allows data to be used without the consent of data subjects. However, in the future much of the data will not be held by public authorities but by private companies. What are the implications of this shift for the governance of the research use of the data? This paper will argue that increased involvement of Research Ethics Committees and better training of researchers are necessary; and that some form of consent will have to be re-introduced. Four different consent models will be discussed: Opt-Out, Broad/Blanket consent, Dynamic consent, and Meta consent. It will be argued that a governance model including a possibility for citizens to make meta-choices strikes the best balance between individual and public interests.
Authors: Fischetti A, Romano N, Mussetto I, Merlo G, Burlando M, Cozzani E, Muda A, Garlaschi G, Parodi A PMID: 30229643 [PubMed - as supplied by publisher]
Authors: Brambilla L, Minuti A, Brambilla M, Tourlaki A, Genovese G, Berti E PMID: 30229642 [PubMed - as supplied by publisher]
Authors: Veraldi S, Moltrasio C, Spinelli F, Nazzaro G PMID: 30229641 [PubMed - as supplied by publisher]
Authors: Radi G, Campanati A, Diotallevi F, Molinelli E, Offidani A Abstract BACKGROUND: Apremilast is a "small molecule", an oral phosphodiesterase 4 inhibitor indicated for the twice- daily treatment of adults with psoriasis (PsO) and psoriatic arthritis (PsA). Data concerning clinical experience in real world setting with Apremilast for psoriasis are still exiguous, and aim of this report is to provide our experience in the use of Apremilast in out-patient setting. METHODS: Ten caucasian individuals (6 male, 4 females; mean age 69,3; range 53-81 years) affected by moderate to severe plaque psoriasi...
Authors: Di Prete M, Ferlosio A, Mazzilli S, Bianchi L, Orlandi A, Campione E PMID: 30229639 [PubMed - as supplied by publisher]
Authors: Rossi A, Garelli V, Muscianese M, Pranteda G, Caro G, D'arino A, Fortuna MC PMID: 30229638 [PubMed - as supplied by publisher]
Authors: Gualtieri B, Panduri S, Chiricozzi A, Romanelli M PMID: 30229637 [PubMed - as supplied by publisher]
CONCLUSIONS: This study demonstrated the increased risk of skin cancer in transplant patients during the first 7 years of follow-up and made the dermatologists aware about the need of a regular cutaneous follow up for this subset of patients. PMID: 30229636 [PubMed - as supplied by publisher]
Authors: Caposiena Caro RD, Coppola A, Didona D PMID: 30229635 [PubMed - as supplied by publisher]
CONCLUSIONS: This study suggests that topical EGF is a safe, noninvasive, and effective treatment for melasma. J Drugs Dermatol. 2018;17(6):970-973. PMID: 30235384 [PubMed - in process]