Rethinking journalism protection : looking beyond copyright

The author thanks Michal Gal, Rossana Ducato, Masako Wakui, and all the participants to the Ascola 2019 conference for helpful comments on previous drafts. A special thanks to Abbe Brown for her thoughtful comments on an earlier draft of this paper. All errors are my own.Peer reviewedPublisher PD

The Italian Competition Authority’s Decision in the Amazon Logistics Case : Self-preferencing and Beyond

Peer reviewedPublisher PD

Causation

Chapter 9 stresses that causation is an essential feature of damages cases for infringements of competition law. The Chapter explores the conceptual foundations of causation in competition law in this context, with the aim to provide a general introduction to the challenges that the requirement of a causal link poses to competition law enforcers, judges or competition authorities, in particular in a complex factual setting. It explores the interplay between the national and EU levels in regulating legal causation in competition law damages cases, the presumptions that have developed in order to facilitate evidence of a causal link, the thorny issue of establishing causation for the indirect victims of anticompetitive conduct, and new challenges in establishing the causal link, in particular the counterfactual test in situations of factual uncertainty, the complexities of establishing causation on the basis of economic and econometric evidence as well as data science evidence. Finally, the Chapter delves into the analysis of the legal aspects for the quantification of damages and some related issues for passing-on

La mappa della pianificazione e la bussola del controllo per orientare la Performance nella P.A.

2012 - 2013Negli ultimi anni la PA italiana ha vissuto un periodo di forte spinta al cambiamento, all’innovazione ed alla modernizzazione che si è tradotto in un sempre maggiore orientamento alla misurazione (performance), alla comunicazione (trasparenza) ed all’integrità (corruzione) dei risultati, in quanto è evidente, costante e condiviso il pensiero secondo cui la macchina amministrativa, nella sua dimensione complessiva, ha tradito le aspettative della collettività lacerando profondamente il rapporto di fiducia verso le stesse istituzion i e creando anche un forte conflitto intergenerazionale. Il dibattito sulla valutazione e sulla misurazione della performance all’interno delle PA rappresenta da anni uno degli ambiti più complessi fra quelli che caratterizzano l’applicazione dei modelli manageriali e gli interventi normativi per cercare di pervenire ad un miglioramento complessivo delle organizzazioni pubbliche non mancano. Le resistenze, le difficoltà e le complessità tuttavia che tale processo di ripensamento ha vissuto ed ancora vive, sono da ricercare in parte anche nell’ “ambiguità” che spesso il concetto aziendale di performance incontra con riferimento ai contesti pubblici. La performance, nella sua globalità, assume all’interno delle PA diversi significati, interpretazioni e applicazioni, generando un’ambiguità da analizzare e circoscrivere per una migliore comprensione delle logiche istituzionali, organizzative, culturali e relazionali che sono alla base di ogni processo di misurazione, valutazione e miglioramento. Una volta comprese le difficoltà e le opportunità insite nella gestione delle performance pubbliche è necessario approfondire il percorso normativo che ha caratterizzato il processo di ripensamento della PA italiana che, soprattutto negli ultimi quindici anni, ha posto molta enfasi sul management per obiettivi e sulla misurazione delle performance collocando al centro del processo di riforma i sistemi di pianificazione e controllo quali processi manageriali essenziali per favorire uno sforzo “disciplinato” ed orientato alla messa in atto di decisioni, azioni e comportamenti positivi. L’analisi sistemica dell’intero processo di riforma, dalla riforma del bilancio del 97 agli attuali interventi in materia di trasparenza e corruzione, grazie al “supporto” fornito dal movimento del NPM, evidenzia come il legislatore abbia voluto imporre le logiche della pianificazione e del controllo allo scopo di sollecitare una mappatura dei pensieri, dei processi e delle attività per orientare le decisioni, le azioni, i comportamenti ed i risultati. Il tutto attraverso l’integrazione delle diverse aree e dimensioni che nell’ambito dei processi organizzativi e gestionali contribuiscono alla creazione di valore. Proprio per rispondere ad una giustificata domanda di comprensione circa l’organicità, la linearità e la validità del percorso normativo intrapreso, si è assunti il Decreto n. 150/2009, noto come “Decreto Brunetta”, come fulcro ed al tempo stesso connettore dell’intero processo normativo degli ultimi anni per testare sia la coerenza dell’impianto con i principi dei sistemi di pianificazione e controllo, sia la coerenza con le finalità di miglioramento complessivo delle organizzazioni. Il problema dunque è quello di comprendere, assunte le complessità e le ambiguità della performance, se, ancora oggi, l’attuale modesto livello di soddisfazione dei bisogni collettivi derivi dell’incoerenza e dalla disorganicità del quadro ordinamentale o da un approccio comportamentale, professionale ed etico del management e delle persone coinvolte. Nel lavoro ci si sofferma sul processo di riforma della PA italiana passando in rassegna i principali contributi della letteratura, ed in particolar modo del new public management, al fine di comprendere le logiche che hanno ispirato il processo di cambiamento della PA. In tale contesto particolare attenzione, sarà dedicata al problema dell’ambiguità analizzando le dimensioni di risultato, in quanto valutare la performance significa valutare gli obiettivi proposti ed i risultati conseguiti oltre che i soggetti coinvolti in tale processi. La “comprensione” degli obiettivi da perseguire rappresenta il momento strategicamente più importante di un qualsiasi processo di rilevazione, misurazione e controllo. Successivamente, al fine di metabolizzare i principi dei processi manageriali tipici della realtà d’impresa, e valutare correttamente l’impianto ordinamentale italiano, ci si soffermerà sui sistemi manageriali di pianificazione e controllo anche per decifrarne il mutamento morfologico - funzionale dagli stessi subito dapprima con la diffusione del NPM e poi con le logiche della Public Governance. Solo dopo aver maturato la giusta convinzione di ciò che dovrebbe essere, ci addentreremo nell’impianto ordinamentale di riferimento per capire ciò che effettivamente è, anche attraverso l'analisi dei connotati essenziali del Decreto Legislativo 150/2009, con particolare riferimento al ciclo di gestione integrato della performance ed alla sua stretta interazione con le sfere del bilancio, dei processi, dell’etica e della trasparenza. L’obiettivo è quello di dimostrate, attraverso lo studio di un caso concreto, come l’implementazione di sistemi e processi manageriali di pianificazione, programmazione e controllo, abbinato ad una corretta interpretazione delle norme, può limitare l’impatto delle ambiguità e supportare l’organizzazione verso comportamenti e pensieri culturalmente orientati al perseguimento dei risultati istituzionali. [a cura dell'autore]XII n.s

The Proper Ki-67 Cut-Off in Hormone Responsive Breast Cancer. A Monoinstitutional Analysis with Long-Term Follow-Up

Introduction: Breast cancer is a heterogeneous disease. Our study focuses on a monoinstitutional series of patients affected by Hormone Responsive carcinomas (luminal A and luminal B) and aims to define an optimal Ki-67 cut-off, to correctly stratify these patients into risk classes, using the ImmunoHistoChemical (IHC) surrogates of the Molecular Subtypes, according to the St. Gallen guidelines. Methods: We analyzed 1685 patients. These patients underwent both radical and conservative surgeries with Sentinel Lymph Node Biopsy eventually followed by Axillary Dissection (AD). Furthermore, all the patients underwent adjuvant therapies according to the guidelines. A retrospective univariate analysis was performed and survival curves (Disease-Related Survival, DRS, and Disease-Free Survival, DFS) were carried out according to the following ki-67 risk classes: Low Risk (Ki-67 ≤ 14%); Intermediate Risk (Ki-67 15% ÷ 20%); High Risk (Ki-67 > 20%). Results: 14 yy DRS was 98% in LA and 85% in LB with a ki-67 cut-off of 14% (p=0.037) vs 95% (LA) and 83% (LB) with a ki-67 cut-off of 20% (p=0.003). 14yy DFS was 85% in LA and 72% in LB with a ki-67 cut-off of 14% (p=0.017) vs 83% (LA) and 66% (LB) with a ki-67 cut-off of 20% (p<0.000). Discussion: Our results confirmed that the 20% Ki-67 cut-off is more reliable in differentiating patients at low or high risk of recurrence and death, and stratifying patients eligible for adjuvant chemotherapy. Thus, despite its poor reproducibility, the identification of the most accurate ki-67 index assumes a pivotal relevance in guiding a tailored strategy among patients with this specific profile of breast cancer, as well as the molecular surrogates, in order to avoid harmful overtreatments

Contralateral prophylactic mastectomies. Correlations between primary tumor and histological findings of controlateral breast

Backgound: In Italy in 2015 48,000 new cases of breast carcinomas were diagnosed. Women who are diagnosed with breast cancer have a significant risk of developing contralateral breast cancer during the rest of their lives and this risk is closely associated to the family history, to the onset of breast cancer at a young age and is expressed at about 0.5 to 1% of metachronous tumors per year. The purpose of this work was to evaluate which and how many neoplastic lesions were seen in the contralateral breast that underwent prophylactic mastectomy and to understand what factors predict the appearance of such lesions. Methods: 168 bilateral mastectomies were analyzed in patients with an average age of 47 years, carried out from July 2008 to April 2016, at the Breast Unit of the Sant’Andrea Hospital. We considered women of any age suffering from unilateral breast cancer without either clinical or radiological evidence of a malignant lesion in the contralateral breast and negative for mutations of the BRCA1-BRCA2 genes test. Of the 168 bilateral mastectomies 35 patients were excluded from the study because they underwent neoadjuvant chemotherapy, another 35 patients because they were suffering from a bilateral neoplasia and 7 cases because they had mutated BRCA1 or BRCA2 genes. Therefore the remaining 91 patients were included in the study. Results: Both the histological features of the primary tumor and any lesions found in the contralateral prophylactic breast were analyzed. Histological examination of the main breast showed 59 cases of Invasive Ductal Carcinoma (IDC), 17 cases of Invasive Lobular Carcinoma (ILC), 9 cases of In Situ Ductal Carcinoma (ISDC), 3 microinvasive ductal, 1 invasive tubular carcinoma, 1 in situ lobular and 1 widespread in situ. In the contralateral breast, the definitive histological examination revealed that 47 patients had an occult lesion in the prophylactic contralateral breast; in particular 2 cases of LIN 1, 7 cases of LIN2, 6 cases of lobular carcinoma in situ, 26 between DIN1A/DIN1A-B/DIN1B, 4 cases of carcinoma in situ and 2 cases of Invasive Ductal Carcinoma. The correlation obtained from the observation of the main tumor has shown that in a total of 59 invasive ductal carcinoma 32 have a controlateral occult lesions and in a total of 17 cases of invasive lobular carcinoma 9 have an occult lesion in the prophylactic breast. Of these lesions, the multicentric relationship is that 50% of invasive ductal and invasive lobular carcinoma of the main breast have a contralateral lesion. Conclusion: In conclusion we would like to remind, as demonstrated by our follow-up data and as the literature reiterates, that this surgery does not improve patient survival. Certainly patients with unilateral breast cancer have many surgical therapies to be able to deal with not only having a bilateral mastectomy. The end point of this work is try to understand the risk factors of having a contralateral breast lesion to reduce the probability of a metachronous cance

Importance of perforating vessels in nipple-sparing mastectomy. an anatomical description

BACKGROUND: Nipple-sparing mastectomy (NSM), understood as an oncologically valid procedure, is relatively new, and is an evolution of traditional mastectomy, particularly in relation to breast-conserving surgery. The anterior perforating branches are responsible for the cutaneous vascularization of the breast skin, and their preservation is a fundamental step to avoid possible postoperative necrosis. Therefore, evaluating the potential complications of cancer-related reconstructive surgical procedures such as NSM, both the distance of the tumoral lesion from the skin and the surgical incision site should be carefully considered. The preferred site of incision corresponds to the inframammary fold or possibly the periareolar area. METHODS: We retrospectively reviewed 113 patients who underwent NSM from January 2005 to October 2012 to evaluate skin complications. The anatomical study was performed by magnetic resonance imaging of the breast. RESULTS: Only one of the 113 women who had undergone a NSM procedure had total necrosis (0.9%) and six patients had partial necrosis (5.8%) of the nipple-areola complex

Influence of Maxillary Sinus Width on New Bone Formation After Transcrestal Sinus Floor Elevation: A Proof-of-Concept Prospective Cohort Study

PURPOSE: Graft maturation in the maxillary sinus requires adequate angiogenesis and osteoprogenitor cells migration from the surrounding bony walls: the aim of this study was to analyze the correlation between sinus cavity dimensions and new bone formation after transcrestal sinus floor elevation (tSFE). METHODS: Patients needing maxillary sinus augmentation (residual crest height 64 4 mm) were treated with tSFE using xenogeneic granules. Six months later, bone-core biopsies were retrieved for histological analysis in the implant insertion sites. Buccopalatal sinus width (SW) was evaluated on cone beam computed tomography, and correlations between histomorphometric and anatomical parameters were quantified by means of linear regression analysis. RESULTS: Eight consecutive patients underwent tSFE procedures: at 6 months, average percentage of newly formed bone resulted 24.2% \ub1 7.9%. Statistical analysis showed a strong inverse correlation between SW and new bone formation (R = 0.88), and a strong direct correlation between the number of exposed bone walls and new bone formation (R = 0.82). CONCLUSION: Within the limitations of this proof-of-concept study, in which a restricted number of patients were analyzed, tSFE showed more predictable results in narrow than in large sinuses, in terms of new bone formation

Malpractice and patient safety descriptors: an innovative grid to evaluate the quality of clinical records

Introduction: The medical record contains all the health information related to the patient’s clinical condition and its evolution during hospitalization. It was defined by the Italian Ministry of Health in 1992 as "The information tool designed to record all relevant demographic and clinical information about a patient during a single episode of hospitalization". The documents and information in a Medical Record must meet the following criteria: traceability, clarity, accuracy, authenticity, pertinence and completeness. The objectives of our study was to develop a tool capable of assessing the quality of the clinical record and pointed the critical point at the Organizational, Technical - Professional, Managerial level. Methods: To evaluate the quality of the medical documentation, we created an assessment grid composed of 4 sections with a total of 92 criteria. This grid was tested on 200 medical records that were randomly selected from 25 (18 medical and 7 surgical) wards of a teaching hospital in Rome. Results: The grid contains 4 sections. The first part regards administrative and clinical data; the second assesses the quality of hospital stay and surgical/invasive procedures; the third part is concerned with the discharge of the patient and the fourth aims to identify the presence of advisory reports given to the patient. This grid has been validated to verify internal consistency with Cronbach's Alpha = 0,743. Conclusions: Medical records were analyzed using a validated tool with grids to identify critical issues in care activities. Weaknesses in the system were identified in order to improve planning. The sample testing also in terms of ‘self-assessment' represents a tool to introduce activities to improve safety and quality of care, greatly reducing the costs of litigation