Status of Fishery Discards and By-Products in Greece and Potential Valorization Scenarios towards a National Exploitation Master Plan.

The valorization of aquaculture/fishery processing by-products, as well as unavoidable/unwanted catches and discards in Greece, is currently an underutilized activity despite the fact that there are several best practices in Northern Europe and overseas. One of the main challenges is to determine whether the available quantities for processing are sufficient to warrant the valorization of discards and fish side streams. This is the first attempt to systematically record and analyze the available quantities of fish by-products and discards in Greece spatially and temporally in an effort to create a national exploitation Master Plan for the valorization of this unavoidable and unwanted biomass. A thorough survey conducted within the VIOAXIOPIO project unveiled a substantial biomass of around 19,000 tonnes annually that could be harnessed for valorization. Furthermore, the production of various High-Added-Value Biomolecules (HAVBs) was investigated and experimental trials were conducted to assess the potential yields, with the collected data used to formulate four valorization scenarios.

Sustainable Production of Biofuels and Biochemicals via Electro-Fermentation Technology.

The energy crisis and climate change are two of the most concerning issues for human beings nowadays. For that reason, the scientific community is focused on the search for alternative biofuels to conventional fossil fuels as well as the development of sustainable processes to develop a circular economy. Bioelectrochemical processes have been demonstrated to be useful for producing bioenergy and value-added products from several types of waste. Electro-fermentation has gained great attention in the last few years due to its potential contribution to biofuel and biochemical production, e.g., hydrogen, methane, biopolymers, etc. Conventional fermentation processes pose several limitations in terms of their practical and economic feasibility. The introduction of two electrodes in a bioreactor allows the regulation of redox instabilities that occur in conventional fermentation, boosting the overall process towards a high biomass yield and enhanced product formation. In this regard, key parameters such as the type of culture, the nature of the electrodes as well as the operating conditions are crucial in order to maximize the production of biofuels and biochemicals via electro-fermentation technology. This article comprises a critical overview of the benefits and limitations of this emerging bio-electrochemical technology and its contribution to the circular economy.

Bioactive Compounds from Organic Waste.

The reuse and reincorporation of waste are the principles of circular economies. Compost, biofuels, animal feed, dyes, and bioactive compounds can be obtained from the revaluation of organic waste. Research on this subject is scarce and limited to specific sectors, such as agriculture and agroindustry, leaving aside others that generate large quantities of organic waste, such as floriculture. The remains of these sectors have a low decomposition rate compared to other organic wastes. They are a source of bioactive compounds (e.g., essential oils, pigments, phenols) that can be reincorporated into the production chain of various industries. This review describes the composition of waste from agroindustry, agriculture, and floriculture, analyzing their potential revalorization as a source of bioactive compounds and an alternative supply source.

Get the win-win: Sustainable circular model of 'generation-value-technology' of industrial solid waste management.

The management of industrial solid waste (ISW) and promoting sustainable circular development of the industrial economy is an urgent priority today. Therefore, this article constructs a sustainable circular model of 'generation-value-technology' of ISW management through the lens of industrial added value (IAV) and technology level. Also, the importance of the role of government is considered in the model. Based on actual data of China, this article simulates the future trend of the model using a system dynamics approach. The chief findings of the study are as follows: (1) under the current policy, China's future industrialization is increasing and the technological level of industrial enterprises is rising, but this is accompanied by a climb in ISW generation. (2) The win-win situation of ISW decrease and IAV increase can be achieved through enhanced information disclosure, technology innovation and government incentives. (3) Government subsidy should be oriented towards supporting technology innovation in industrial enterprises while reducing the proportion of incentives for ISW management results. Based on the results, this study proposes targeted policy implications for government and industrial enterprises.

Direct 16S/18S rRNA Gene PCR Followed by Sanger Sequencing as a Clinical Diagnostic Tool for Detection of Bacterial and Fungal Infections: a Systematic Review and Meta-Analysis.

rRNA gene Sanger sequencing is being used for the identification of cultured pathogens. A new diagnostic approach is sequencing of uncultured samples by using the commercial DNA extraction and sequencing platform SepsiTest (ST). The goal was to analyze the clinical performance of ST with a focus on nongrowing pathogens and the impact on antibiotic therapy. A literature search used PubMed/Medline, Cochrane, Science Direct, and Google Scholar. Eligibility followed PRISMA-P criteria. Quality and risk of bias were assessed drawing on QUADAS-2 (quality assessment of diagnostic accuracy studies, revised) criteria. Meta-analyses were performed regarding accuracy metrics compared to standard references and the added value of ST in terms of extra found pathogens. We identified 25 studies on sepsis, infectious endocarditis, bacterial meningitis, joint infections, pyomyositis, and various diseases from routine diagnosis. Patients with suspected infections of purportedly sterile body sites originated from various hospital wards. The overall sensitivity (79%; 95% confidence interval [CI], 73 to 84%) and specificity (83%; 95% CI, 72 to 90%) were accompanied by large effect sizes. ST-related positivity was 32% (95% CI, 30 to 34%), which was significantly higher than the culture positivity (20%; 95% CI, 18 to 22%). The overall added value of ST was 14% (95% CI, 10 to 20%) for all samples. With 130 relevant taxa, ST uncovered high microbial richness. Four studies demonstrated changes of antibiotic treatment at 12% (95% CI, 9 to 15%) of all patients upon availability of ST results. ST appears to be an approach for the diagnosis of nongrowing pathogens. The potential clinical role of this agnostic molecular diagnostic tool is discussed regarding changes of antibiotic treatment in cases where culture stays negative.

Added value of randomised biopsy to multiparametric magnetic resonance imaging-targeted biopsy of the prostate in a contemporary cohort.

OBJECTIVE: To assess the added value of concurrent systematic randomised ultrasonography-guided biopsy (SBx) to multiparametric magnetic resonance imaging (mpMRI)-targeted biopsy and the additional rate of overdiagnosis of clinically insignificant prostate cancer (ciPCa) by SBx in a large contemporary, real-world cohort. PATIENTS AND METHODS: A total of 1552 patients with positive mpMRI and consecutive mpMRI-targeted biopsy and SBx were enrolled. Added value and the rate of overdiagnosis by SBx was evaluated. PRIMARY OUTCOME: added value of SBx, defined as detection rate of clinically significant PCa (csPCa; International Society of Urological Pathology [ISUP] Grade ≥2) by SBx, while mpMRI-targeted biopsy was negative or showed ciPCa (ISUP Grade 1). SECONDARY OUTCOME: rate of overdiagnosis by SBx, defined as detection of ciPCa in patients with negative mpMRI-targeted biopsy and PSA level of <10 ng/mL. RESULTS: Detection rate of csPCa by mpMRI-targeted biopsy and/or SBx was 753/1552 (49%). Added value of SBx was 145/944 (15%). Rate of overdiagnosis by SBx was 146/656 (22%). Added value of SBx did not change when comparing patients with previous prostate biopsy and biopsy naïve patients. In multivariable analysis, a Prostate Imaging-Reporting and Data System (PI-RADS) 4 index lesion (odds ratio [OR] 3.19, 95% confidence interval [CI] 1.66-6.78; P = 0.001), a PI-RADS 5 index lesion (OR 2.89, 95% CI 1.39-6.46; P = 0.006) and age (OR 1.05, 95% CI 1.03-1.08; P < 0.001) were independently associated with added value of SBx. CONCLUSIONS: In our real-world analysis, we saw a significant impact on added value and added rate of overdiagnosis by SBx. Subgroup analysis showed no significant decrease of added value in any evaluated risk group. Therefore, we do not endorse omitting concurrent SBx to mpMRI-guided biopsy of the prostate.

Cleaning Up without Messing Up: Maximizing the Benefits of Plastic Clean-Up Technologies through New Regulatory Approaches.

As the global plastics crisis grows, numerous technologies have been invented and implemented to recover plastic pollution from the environment. Although laudable, unregulated clean-up technologies may be inefficient and have unintended negative consequences on ecosystems, for example, through bycatch or removal of organic matter important for ecosystem functions. Despite these concerns, plastic clean-up technologies can play an important role in reducing litter in the environment. As the United Nations Environment Assembly is moving toward an international, legally binding treaty to address plastic pollution by 2024, the implementation of plastic clean-up technologies should be regulated to secure their net benefits and avoid unintended damages. Regulation can require environmental impact assessments and life cycle analysis to be conducted predeployment on a case-by-case basis to determine their effectiveness and impact and secure environmentally sound management. During operations catch-efficiency and bycatch of nonlitter items, as well as waste management of recovered litter, should be documented. Data collection for monitoring, research, and outreach to mitigate plastic pollution is recommended as added value of implementation of clean-up technologies.

Quantifying population-level conservation impacts for a perpetual conservation program on private land.

Area-based targets, such as percentages of regions protected, are popular metrics of success in the protection of nature. While easily quantified, these targets can be uninformative about the effectiveness of conservation interventions and should be complemented by program impact evaluations. However, most impact evaluations have examined the effect of protected areas on deforestation. Studies that have extended these evaluations to more dynamic systems or different outcomes are less common, largely due to data availability. In these cases, simulations might prove to be a valuable tool for gaining an understanding of the potential range of program effect sizes. Here, we employ simulations of wetland drainage to estimate the impact of the United States Fish and Wildlife Service Small Wetlands Acquisition Program (SWAP) across a ten-year period in terms of wetland area, and breeding waterfowl and brood abundance in the Prairie Pothole Region of North Dakota, South Dakota, and Montana. Using our simulation results, we estimate a plausible range of program impact for the SWAP as an avoided loss of between 0.00% and 0.02% of the carrying capacity for broods and breeding waterfowl from 2008-2017. Despite the low programmatic impact that these results suggest, the perpetual nature of SWAP governance provides promising potential for a higher cumulative conservation impact in the long term if future wetland drainage occurs.

Resource recovery and valorization of food wastewater for sustainable development: An overview of current approaches.

The food processing industry is one of the world's largest consumers of potable water. Agri-food wastewater systems consume about 70% of the world's fresh water and cause at least 80% of deforestation. Food wastewater is characterized by complex composition, a wide range of pollutants, and fluctuating water quality, which can cause huge environmental pollution problems if discharged directly. In recent years, food wastewater has attracted considerable attention as it is considered to have great prospects for resource recovery and reuse due to its rich residues of nutrients and low levels of harmful substances. This review explored and compared the sources and characteristics of different types of food wastewater and methods of wastewater treatment. Particular attention was paid to the different methods of resource recovery and reuse of food wastewater. The diversity of raw materials in the food industry leads to different compositional characteristics of wastewater, which determine the choice and efficiency of wastewater treatment methods. Physicochemical methods, and biological methods alone or in combination have been used for the efficient treatment of food wastewater. Current approaches for recycling and reuse of food wastewater include culture substrates, agricultural irrigation, and bio-organic fertilizers, recovery of high-value products such as proteins, lipids, biopolymers, and bioenergy to alleviate the energy crisis. Food wastewater is a promising substrate for resource recovery and reuse, and its valorization meets the current international policy requirements regarding food waste and environment protection, follows the development trend of the food industry, and is also conducive to energy conservation, emission reduction, and economic development. However, more innovative biotechnologies are necessary to advance the effectiveness of food wastewater treatment and the extent of resource recovery and valorization.

Enzymatic Cocktail Formulation for Xylan Hydrolysis into Xylose and Xylooligosaccharides.

In the context of a biorefinery, lignocellulosic materials represent an important source of raw material for the bioconversion of cellulose, hemicellulose, and lignin into value-added products, such as xylose for fermentation, oligosaccharides, and bioplastics for packaging. Among the most abundant lignocellulosic materials in Brazil, sugarcane bagasse biomass stands out, as it is rich in cellulose and hemicellulose. In this context, through an experimental design, this study developed a robust enzyme cocktail containing xylanases and accessory enzymes to complete the hydrolysis of xylan from sugarcane bagasse, obtaining a low xylose yield and concentration (9% and 1.8 g/L, respectively, observed in experiment number 16 from the complete hydrolysis of a xylan assay), a fermentable sugar that is important in the production of second-generation ethanol, and a high xylooligosaccharides (XOS) yield and concentration (93.1% and 19.6 g/L, respectively, obtained from a xylooligosaccharides production assay); in general, xylan has prebiotic activities that favor an improvement in intestinal functions, with immunological and antimicrobial actions and other benefits to human health. In addition to completely hydrolyzing the sugarcane bagasse xylan, this enzymatic cocktail has great potential to be applied in other sources of lignocellulosic biomass for the conversion of xylan into xylose and XOS due to its enzymes content, involving both main chain and pendant groups hydrolysis of hemicelluloses.

A Review on the Potential Bioactive Components in Fruits and Vegetable Wastes as Value-Added Products in the Food Industry.

The food production industry is a significant contributor to the generation of millions of tonnes of waste every day. With the increasing public concern about waste production, utilizing the waste generated from popular fruits and vegetables, which are rich in high-added-value compounds, has become a focal point. By efficiently utilizing food waste, such as waste from the fruit and vegetable industries, we can adopt a sustainable consumption and production pattern that aligns with the Sustainable Development Goals (SDGs). This paper provides an overview of the high-added-value compounds derived from fruit and vegetable waste and their sources. The inclusion of bioactive compounds with antioxidant, antimicrobial, and antibrowning properties can enhance the quality of materials due to the high phenolic content present in them. Waste materials such as peels, seeds, kernels, and pomace are also actively employed as adsorbents, natural colorants, indicators, and enzymes in the food industry. Therefore, this article compiles all consumer-applicable uses of fruit and vegetable waste into a single document.

Comparison of voluntary and forced digital leaps in higher education - Teachers' experiences of the added value of using digital tools in teaching and learning.

The study examines the benefits of digital tools in teaching and learning as experienced by university teachers in two different time periods: 1) during the controlled digital leap before the Covid-19 pandemic (2017-2019) and 2) during the emergency imposition of remote teaching in response to the lockdown aimed at containing the Covid-19 pandemic (2020). Teachers in different academic fields at a large multidisciplinary Finnish university (N1 = 303 and N2 = 265) responded to two open-ended questions as part of a broader questionnaire. The research identified four kinds of benefits related to digital teaching: (1) practical and administrative and (2) independence of time and place, implying practical and technical benefits; as well as (3) enhancing learning and (4) developing teaching, which are primarily pedagogical benefits, related to teaching and learning. Voluntary and forced digital leaps provided different kinds of consequences in teaching and learning. Digital tools generally provided practical and technological benefits for teaching and learning during the controlled digital leap, but they also had positive pedagogical effects. The forced digital leap, in turn, demonstrated the value of time-and-place-independent online teaching and learning. It also exposed differences among academic fields in how teachers experienced the benefits of using digital tools. Support of and training for university teachers should take into account the different needs of faculties and disciplines, and promote dialogue between pedagogical and technological interests.

Evaluation of the Value of Waist Circumference and Metabolomics in the Estimation of Visceral Adipose Tissue.

Visceral adipose tissue (VAT) is a strong prognostic factor for cardiovascular disease and a potential target for cardiovascular risk stratification. Because VAT is difficult to measure in clinical practice, we estimated prediction models with predictors routinely measured in general practice and VAT as outcome using ridge regression in 2,501 middle-aged participants from the Netherlands Epidemiology of Obesity study, 2008-2012. Adding waist circumference and other anthropometric measurements on top of the routinely measured variables improved the optimism-adjusted R2 from 0.50 to 0.58 with a decrease in the root-mean-square error (RMSE) from 45.6 to 41.5 cm2 and with overall good calibration. Further addition of predominantly lipoprotein-related metabolites from the Nightingale platform did not improve the optimism-corrected R2 and RMSE. The models were externally validated in 370 participants from the Prospective Investigation of Vasculature in Uppsala Seniors (PIVUS, 2006-2009) and 1,901 participants from the Multi-Ethnic Study of Atherosclerosis (MESA, 2000-2007). Performance was comparable to the development setting in PIVUS (R2 = 0.63, RMSE = 42.4 cm2, calibration slope = 0.94) but lower in MESA (R2 = 0.44, RMSE = 60.7 cm2, calibration slope = 0.75). Our findings indicate that the estimation of VAT with routine clinical measurements can be substantially improved by incorporating waist circumference but not by metabolite measurements.

Yarrowia lipolytica as a biorefinery platform for effluents and solid wastes valorization - challenges and opportunities.

Due to its physiological and enzymatic features, Yarrowia lipolytica produces several valuable compounds from a wide range of substrates. Appointed by some authors as an industrial workhorse, Y. lipolytica has an extraordinary ability to use unrefined and complex low-cost substrates as carbon and nitrogen sources, aiding to reduce the waste surplus and to produce added-value compounds in a cost-effective way. Dozens of review papers regarding Y. lipolytica have been published till now, proving the interest that this yeast arouses in the scientific community. However, most of them are focused on metabolic pathways involved in substrates assimilation and product formation, or the development of synthetic biology tools in order to obtain engineered strains for biotechnological applications. This paper provides an exhaustive and up-to-date revision on the application of Y. lipolytica to valorize liquid effluents and solid wastes and its role in developing cleaner biotechnological approaches, aiming to boost the circular economy. Firstly, a general overview about Y. lipolytica is introduced, describing its intrinsic features and biotechnological applications. Then, an extensive survey of the literature regarding the assimilation of oily wastes (waste cooking oils, oil cakes and olive mill wastewaters), animal fat wastes, hydrocarbons-rich effluents, crude glycerol and agro-food wastes by Y. lipolytica strains will be discussed. This is the first article that brings together the environmental issue of all such residues and their valorization as feedstock for valuable compounds production by Y. lipolytica. Finally, it will demonstrate the potential of this non-conventional yeast to be used as a biorefinery platform.

Diagnostic accuracy of pleural fluid lactate dehydrogenase to adenosine deaminase ratio for tuberculous pleural effusion: an analysis of two cohorts.

BACKGROUND: This study aimed to evaluate the diagnostic accuracy of pleural fluid (PF) lactate dehydrogenase (LDH) to adenosine deaminase (ADA) (LDH/ADA) ratio for tuberculous pleural effusion (TPE). Especially to explore whether the LDH/ADA ratio provides added diagnostic value to ADA. METHODS: The diagnostic accuracy of PF LDH/ADA ratio and ADA for TPE was evaluated in two cohorts, named the BUFF (Biomarkers for patients with Undiagnosed pleural eFFusion) cohort (62 with TPE and 194 with non-TPE) and the SIMPLE (a Study Investigating Markers in PLeural Effusion) cohort (33 with TPE and 177 with non-TPE). Receiver operating characteristic (ROC) curve and decision curve were used to measure the diagnostic accuracy of the PF LDH/ADA ratio. The added diagnostic value of the LDH/ADA ratio to ADA was evaluated with net reclassification improvement (NRI) and integrated discrimination improvement (IDI). RESULTS: The area under the ROC curves (AUCs) of PF ADA and LDH/ADA ratio in the BUFF cohort were 0.76 and 0.74, respectively. In the SIMPLE cohort, the AUCs of PF ADA and LDH/ADA ratio were 0.80 and 0.85, respectively. The decision curves of PF LDH/ADA and ADA were close in both the BUFF and SIMPLE cohorts. The NRI and IDI analyses did not reveal any added diagnostic value of LDH/ADA to ADA. CONCLUSIONS: PF LDH/ADA ratio has moderate diagnostic accuracy for TPE. It does not provide added diagnostic value beyond ADA. The current evidence does not support LDH/ADA ratio for diagnosing TPE.

The diagnostic levels of evidence of instrumented devices for measuring viscoelastic joint properties and spasticity; a systematic review.

BACKGROUND: Many diagnostic robotic devices have been developed to quantify viscoelastic properties and spasticity of patients with upper motor neuron lesions. However, in clinical practice, subjective and nonvalid clinical scales are still commonly used. To understand the limited use of diagnostic robotic devices assessing viscoelastic joint properties and spasticity in clinical practice, we evaluate the diagnostic level of evidence of studies on these devices. METHOD: A systematic literature review was performed using multiple databases. Two of the authors independently screened all articles. Studies investigating human subjects diagnosed with stroke or cerebral palsy, measured with a mechanical device to assess viscoelastic joint properties and/or spasticity of an extremity. All articles were assigned a diagnostic level of evidence, which was established with a classification strategy based on the number of participants and the design of the study, from a Level 0 (less than 10 subjects) to a Level IV, reporting the long-term clinical consequences in daily care. RESULTS: Fifty-nine articles were included. Most studies measured the upper limb (64%) in stroke patients (81%). The highest level of evidence found was Level IIa (53%); these studies correlated the test values of the robotic device with a clinical test or within subgroups. Level 0 (30%) and Level I (17%; determining the range of values of the robotic test) were also common. None of the studies tested their device for diagnostic accuracy (Level III), clinical added value (Level IV). CONCLUSION: The diagnostic evidence needed for implementing robotic devices in clinical practice is lacking. Our findings indicate that more effort should be invested in studying diagnostic accuracy (Level III) or added value for clinical care (Level IV); only these studies can provide clinicians with evidence that robotic devices have added value above the currently-used clinical scales.

The added value and unintended negative consequences of public involvement processes in the planning, development and implementation of community health services: Results from a thematic synthesis.

PURPOSE: Public involvement is widely considered a means to improve health and quality of health services. The research literature reveals ambiguities concerning added value and unintended negative consequences of public involvement processes. The aim of this study is to identify, synthesise and present an overview of added value and unintended negative consequences of public involvement processes in the planning, development and implementation of community health services. METHODS: Data from 36 peer-reviewed articles retrieved from a systematic search in the CINAHL, Cochrane Library, Embase, PsycINFO, PubMed, ProQuest, and Scopus databases in October 2019 and updated in April 2021 were extracted. A three-step thematic synthesis was conducted involving (1) line-by-line text coding, (2) developing descriptive themes and (3) generating analytical themes. RESULTS: Two main themes along with their corresponding themes provided an overview of the added value of public involvement processes at the individual, service and political levels. Unintended negative consequences concerning individual resources, uncertainty about the effect of involvement and power differences were revealed. CONCLUSION: Added value of public involvement processes is primarily reported on an individual and service level. The added value seems to be accompanied by unintended negative consequences. Training of professional facilitators and recruitment of participants that come from vulnerable groups could help promote equality in public involvement. Unintended negative consequences need to be further explored in future evaluations in order to achieve the desired goals of public involvement.

Whole wheat bread enriched with silver fir (Abies alba Mill.) needles extract: technological and antioxidant properties.

BACKGROUND: The interest of consumers and market and scientific research for added-value foods obtained with environmentally sustainable productive chains is increasing. Silver fir (Abies alba Mill.) needles (SFNs), often by-products of forest management and logging, represent an unexploited source of bioactive compounds. RESULTS: For the first time, SFN aqueous extract obtained through controlled hydrodynamic cavitation was used to enrich whole wheat flour bread. The first trial found that 35% SFNs extract addition was the absolute threshold of taste perception. The second trial investigated dough rheological properties and bread technological and antioxidant properties in samples enriched with 35% and 100% SFNs extract compared with the control (0% SFNs extract). SFNs extract significantly increased bread antioxidant capacity in both 35% and 100% SFN fresh breads by ~42.5% and ~87% respectively and in 100% SFNs bread samples after 72 h of storage by ~76%. Enrichment of 35% showed higher alveograph dough extensibility (~11%) and different bread texture in terms of hardness, springiness, and chewiness. Enrichment with 100% SFNs extract significantly improved dough and bread technological quality: it increased alveograph dough extensibility L (~18%), swelling index G (~8%), and flour strength W (~14%) and showed the highest increase in bread specific volume (~0.200 L kg-1 ). CONCLUSIONS: SFNs aqueous extract produced with controlled hydrodynamic cavitation appeared a valuable technical material for the manufacturing of added-value and functional breads. © 2021 Society of Chemical Industry.

Biological production of xylitol by using nonconventional microbial strains.

Xylitol (C5H12O5), an amorphous sugar alcohol of crystalline texture has received great interest on the global market due to its numerous applications in different industries. In addition to its high anticariogenic and sweetening properties, characteristics such as high solubility, stability and low glycemic index confer xylitol its fame in the food and odontological industries. Moreover, it also serves as a building-block in the production of polymers. As a result of the harmful effects of the chemical production of xylitol, the biotechnological means of producing this polyol have evolved over the decades. In contrast to the high consumption of energy, long periods of purification, specialized equipment and high production cost encountered during its chemical synthesis, the biotechnological production of xylitol offers advantages both to the economy and the environment. Non-Saccharomyces yeast strains, also termed as nonconventional, possess the inherent capacity to utilize D-xylose as a sole carbon source, unlike Saccharomyces species.

[Evidence-based health care with pharmaceuticals for rare diseases: the role of digitalisation]. / Evidenzbasierte Arzneimittelversorgung bei Seltenen Erkrankungen: die Rolle der Digitalisierung.

Knowledge generation in the field of drug development for people with rare diseases (RDs) faces particular difficulties. This paper will show what improvements are expected from increasing digitalisation from the perspective of three healthcare institutions: the Federal Institute for Drugs and Medical Devices, the Institute for Quality and Efficiency in Health Care and the Federal Joint Committee.First, the potential of digitalisation to increase the efficiency of clinical development and regulatory decision-making through earlier collaboration of all stakeholders is proposed. Subsequently, it is argued that digitalisation should be used to reduce barriers to the implementation of care-associated randomised controlled trials, including those based on registries. High-quality registry studies should not only be started after approval but during the approval process, so that the evidence necessary for therapy decisions is available promptly after approval. Finally, it is stated that improving the evidence base through qualitative improvement of the data sources and their linkages directly benefits patients. Usable evidence that can be generated over a longer period of time - also beyond approval - and contribute to decisions within healthcare system ensures effective drug provision.The institutions agree that high-quality indication registries should be developed as product-independent, standing infrastructures so that high-quality data can be accessed early in the development of medicines for RD.