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The European Health Data Space and the Secondary Use of Sensitive Health Data.

INTRODUCTION: The European Health Data Space (EHDS) is one of the European Union's most ambitious data-governance projects. It aims to create a common framework through which electronic health data can be accessed and reused across Member States for care, research, innovation, policy, and public-interest purposes. Its practical viability depends not only on digital infrastructure, but also on legal, ethical, and organisational harmonisation, particularly for genetic and genomic data. METHODS: This paper examines the EHDS with emphasis on the secondary use of health data. It reviews the EHDS institutional architecture, discusses Finland's Findata as a national model for structured access, and analyses challenges for data holders and data donors, including interoperability, governance burdens, privacy protection, residual re-identification risk, and genomic-data sensitivity. RESULTS: A cross-border cancer-genomics case study shows that the EHDS can streamline data discovery and the routing of access requests, but does not by itself eliminate legal fragmentation, heterogeneous ethics review, and consent-related barriers. DISCUSSION: Effective implementation will require harmonisation beyond infrastructure, including clearer consent standards, more consistent ethics procedures, interoperable metadata, and proportionate safeguards for genomic data.

Electronic Health Records

A Sociotechnical Approach to Genomic Data Privacy: A Comparative Analysis.

The sharing of genomic data across international borders presents significant privacy law challenges.Secured computed environments on smartphones allow the storing and processing of sensitive data without the underlying data being shared with processors.A novel technology, described here, to process genomic data within a secured computing environment seems to comport with EU and US privacy laws, despite their differing aims and rules.This technology suggests there may be technological solutions to privacy law fragmentation across jurisdictions, so long as data subjects socially trust the technology and have control over their data.

genome

[Changes in the pulse variability of operators on a 12-hour work shift regimen].

Studies are carried out on 51 workers from the state works "D. Dimov"--Yambol on the changes of the pulse variability in the course of 12-hour day and night shift work and subjective evaluation of the psychosomatic complaints, in view of assessment the work load and strain. This investigation is performed because the workers have lodged a complaint against the introduction of 12-hour shift regime of work. It is done twice--during the day and during the night shift. No changes giving indication for considerable over pressure of the physiological systems and decrease of the working capacity have been established during the working process. The conclusion is that this type of working activity--12-hour shift schedule endangers neither the health status of the workers, nor the security and reliability of the system "man-machine-environment" therefore its introduction is not in contradiction to the physiologically well-grounded norms for the organization of the working process.

Adult

Group therapy in a forensic setting.

Mentally ill offenders are especially difficult patients to rehabilitate. Although group therapy is a universal method of treating these patients, their ability to benefit from group therapy has not been proven. The authors studied a group of patients held on Warrants of the Lieutenant Governor to assess their personality characteristics and their ability to develop group dynamics which are beneficial in other patient populations. The findings were that forensic patients have personality characteristics which preclude the development of these therapeutic dynamics.

Activities of Daily Living

The self-organization of human psychological functioning.

This article describes the traditional model of human psychological functioning which dominates current theorizing, contrasts it with the new, emerging perspective of self-organizing processes, and applies this new approach to a theory of human psychological functioning. In the traditional model there is an assumption that processes of functioning are discretely different from physical structure. This assumption is shown to be intrinsic to a linear conceptual framework which implies that (a) stability of functioning derives from physical structure; (b) functioning is determined by the effects of enduring, antecedent components; (c) the environment can selectively influence structure; and (d) observational methods are capable of accessing and revealing processes of functioning. In the contrasting self-organizational perspective, structure and functioning are assumed to be given in one another at the level of organizational process. This formulation implies that as a system functions (a) its orderliness and stability are being determined by the ongoing functioning itself; (b) at the level or organizational functioning there are no antecedent structures separate from consequent activity; (c) systemic functioning exists as a unitary and continuous organizational process; and (d) organizational functioning cannot be instructed by environmental events. The work of Prigogine and of Maturana are examined as a basis for a theory of human psychological functioning as a self-organizing system. The theory that is proposed describes how attentional and experiential functioning evolve as a system of organizational continuity and coherence and how the process by which people recognize and identify their functioning secures this organizational functioning.

Adaptation, Psychological

A computer-based, automated, telephonic system to monitor patient progress in the home setting.

In this report we describe an automated, telephonic system to monitor the progress of patients convalescing at home. The system includes a computerized central station that is capable of automated voice communication over the telephone, using voice reproduction, and touch-tone recognition. Peripheral hardware in multiple monitored homes need include only a touch-tone telephone, but may also be augmented by inexpensive, rudimentary diagnostic aids, such as a scale for body weight, a thermometer, or a blood pressure cuff and manometer. Current central hardware includes a NeXT computer, a fax modem, and a specialized telecommunications modem developed specifically for voice telecommunication using the NeXT. The central station acts like a robotic nurse in that it asks patients a series of questions and records the responses. The subjective questions to be asked are patient individualized and pre-selected by the physician from a question menu including items targeted specifically for the patient's disease or condition. In addition, clinical data such as body weight, blood pressure, and body temperature obtained from in-home diagnostic aids may be transmitted to the central station over the telephone using touch tones. The time-of-day and frequency of calling are pre-selectable, according to the patient's preference and clinical status. Data obtained by the central station can be easily accessed by the duty nurse via menu driven software. Reports depicting significant responses as a function of time are generated in graphical format to facilitate rapid identification of adverse trends. Hard copy reports can be dispersed directly by fax. Results from a pilot study show patients with cardiac disease readily use the system without difficulty or complaints. In one patient a five pound increase in body weight was detected, which prompted the patient's cardiologist to adjust his medication. In this way automated telephone follow-up can provide early detection of complications before they become severe, making the home environment safer and more secure for convalescence and contributing to reduced health-care costs.

Computer Systems

Quality improvement: the nurse's role.

Continuous quality improvement is a concept which includes: Quality assurance--the provision of services that meet an appropriate standard. Problem resolution--including all departments involved in the issue at hand. Quality improvement--a continuous process involving all levels of the organization working together across departmental lines to produce better services for health care clients. Deming (1982b) and others have espoused total system reform to achieve quality improvement--not merely altering the current system, but radically changing it. It must be assumed that those who provide services at the staff level are acting in good faith and are not willfully failing to do what is correct (Berwick, 1991). Those who perform direct services are in an excellent position to identify the need for change in service delivery processes. Based on this premise, the staff nurse--who is at the heart of the system--is the best person to assess the status of health care services and to work toward improving the processes by which these services are provided to clients in the health care setting. The nurse manager must structure the work setting to facilitate the staff nurse's ability to undertake constructive action for improving care. The use of quality circles, quality councils, or quality improvement forums to facilitate the coordination of quality improvement efforts is an effective way to achieve success. The QA coordinator assists departments in documenting that the quality improvement efforts are effective across all departments of the organization, and aggregates data to demonstrate that they meet the requirements of external regulatory agencies, insurers, and professional standards. The nurse executive provides the vision and secures the necessary resources to ensure that the organization's quality improvement efforts are successful. By inspiring and empowering the staff in their efforts to improve the process by which health care is provided, nurse managers participate in reshaping the health care environment. The professional nurse plays a vital role in the quality improvement of health care services. However, nurses cannot make these improvements in a vacuum; they must include other professionals and ancillary personnel in their efforts. Total quality commitment must include all levels of an organization's structure. Quality patient care services will be achieved as the result of positive interactions among departments working together to build a dynamic mechanism that continuously improves the processes and outcomes of health care services.

Humans

Diffusion of associate degree nursing programs among U.S. community colleges.

Examinations of the adoption and diffusion processes relative to innovations have focused on a variety of factors including the characteristics of the environment, the adoptive unit, and the innovation itself. This study explored the relationship between environmental factors, organizational characteristics, and the spread of 2-year associate degree nursing (ADN) programs among community colleges in the U.S. Data were secured from census materials, educational directories, community college catalogs, various other documents, and interviews with community college representatives. Results indicated that such factors as general population heterogeneity, change and wealth, and various measures of the need for nurses and nursing education were not useful predictors of the prevalence of ADN programs among the population of community colleges in a state. Two-year colleges that operated ADN programs were larger, wealthier, offered more occupational programs, and were more likely to be publicly controlled than were community colleges that had not adopted the ADN program feature. Analysis of case materials suggested that at the community level, hospitals and hospital-sponsored nursing schools were important factors in the community college's decision to adopt or reject the ADN program feature.

Communication

[Quality circles as a strategy of a medical care quality assurance program at the Perinatology National Institute].

The present article shows the methodology of implantation of a quality guarantee program of medical attention through quality circles at the National Institute of Perinatology and it's results. Among them emphasize the following: organization's structure effects. The optimum on resources in it's own process of attention on the satisfaction of the patients and in the learning implicated in the adaptation of the technology to the hospital environment and the characteristics of a different culture from which that technology emerged. The project, conceived as investigation-action, was advised by Public Health Investigation Center and was created with the purpose to secure that the organized conditions under which the medical attention are given were those permitting to raise the quality as much in the among personal dimension as in the technical, through the participation of the personnel directly responsible of the services given. This led to the use of quality circles as participant technical of quality control and as main quality guarantee program of medical attention. Seven stages can be identified in the implantation of the quality assurance program using the quality circles: 1) to elaborate the proposal document and work protocol; 2) negotiation; 3) drawing of a guide for the elaboration of a quality guarantee manual; 4) selection the point of starting; 5) elaboration of the quality guarantee manual by service; 6) to operate the quality circles; 7) evaluation of the program. This experience has demonstrated it's feasible using the quality circles as fundamental components of a quality guarantee program of medical attention and permits to secure that, in general, it is possible to use this technology in the health services.

Delivery of Health Care

[Adaptation problems in old age].

The authors summarize available literature concerned with some problems of aging and old age. Attention is devoted in particular to factors which have an adverse impact on this process such as loss of the partner, retirement, disintegration of the home, reduced activity, etc. Some typical diseases of old age are mentioned. The authors emphasize that it is not enough to ensure economic and biological needs. Attention is paid in particular to problems of psychosocial adaptation of old people when going to a different, though sometimes more secure environment. Adaptation responses in the mental sphere may be sometimes very serious and may have tragic consequences for old people. As in contemporary society change of environment on social and health grounds is relatively frequently necessary, the authors summarize the literature on this problem and give an account of views how to prevent sequelae of impaired adaptation or how to mitigate them.

Adaptation, Psychological

The creative person as maverick.

The innate talents that are the essence of creativity are associated with a particular type of character structure. The child's creative potential has to be supported by the infantile milieu, which also happens to have a characteristic stamp. Within this context of personality configurations and developmental antecedents associated with creative ability, there can be considerable variation. I am not postulating a specific or stereotypic creative character. There are, however, certain qualities that can be found in various character types (and can even exist alongside psychopathology) that are often found in creative scientists and perhaps artists as well. I believe the maverick often possesses these character traits and many of the scientists I have had the opportunity of treating proudly considered themselves mavericks. The creative personality is characterized by paradoxes; these cast it in the maverick mold. Possessors of this personality belong and do not belong. They do not break the rules but bend them a little. They are nonconformists but not rebels. They display many features that do not seem to belong together. The paradoxical qualities that dominate the creator's personality and behavior are the outcome of a certain fluidity of character and ego boundaries. The creative process involves a broad range of functioning and traverses various levels of the psyche, frequently reaching down to the very earliest, primary-process-oriented parts of the self. Ego boundaries, in turn, can become quite fluid and permeable, even though they are ordinarily firmly established and well structured. It is this broad spectrum, a prominent feature of the creative process (Giovacchini, 1965, 1971, 1981), that has been often confused with psychopathology. These paradoxical elements are the outcome of an infantile environment that has provided considerable gratification. Again the early milieu of creative personalities may be extremely varied, but there has always been some person or persons who have had a considerable emotional investment in the child. As the developing psyche incorporates and introjects these gratifying and security-establishing experiences, they become amalgamated into the self-representation. In the face of adversity, they provide confidence and reassurance and allow the creator to soothe him- or herself when upset by inner tension. Consequently, creative scientists do not depend so much on the outer world as they do on inner resources. One scientist told me that he could not understand how anyone could ever be bored. Even if he were denied access to his work, he could always find something interesting to do or explore.(ABSTRACT TRUNCATED AT 400 WORDS)

Aptitude

A concept of analytical treatment for patients with psychosomatic disorders. Report on the psychosomatic phenomenon and its consequence for therapy.

With the Paris school the author holds the view that the 'pensée opératoire' is pathognomic for the psychosomatic patient. This archaic, 'automatistisch-mechanistisch' thinking is a consequence of defects in the sphere of the physiological pre-ego. Certain typical findings, such as reduplication and mechanized object relations are seen as correlates of disturbances in the patient's early identification processes. Analytical therapy must thus aim at shifting the all but inaccessible psychosomatic phenomenon into a historical perspective. The psychological event can set in only when the patient has discovered the connexion between his somatic reaction patterns and the emotions he is beginning to feel for the security-giving therapist. An account of the development of the treatment of one patient (Birgit) illustrates the author's concept of analytical therapy in psychosomatics. The 'facilitating environment' helped the patient Birgit to differentiate herself from her dual object and thus to be able to cathect the level of the triangular relationship. The concept of the model ward led on to the development of an ambulatory method of therapy, 'relaxation analytique', which is based on investigations into the concept of the holding function. 'Taking care' of the patient is function of the therapist's own inner attitude, of his being prepared to do everything to encourage the therapeutic regression. The correlate of this attitude, on the side of the patient, is the sense of security which is an essential condition for the 'new beginning' to set in.

Adult

Risk governance of transgenic plants: bridging science, policy, and public trust.

Transgenic plants and genome editing technologies are revolutionizing agriculture through sustainable approaches to food security, pest management, and adaptation to climate change; but their widespread use is hampered by regulatory systems that are fragmented, ethics considerations, and an ongoing lack of trust from the general public. In contrast to other literature that evaluates regulation processes and public acceptance separately, our review paper introduces a new, holistic approach that includes both technical risk assessment from a scientific perspective, and Codex Alimentarius and OECD standards, and the socio-legal and judicial environment of how the national policy decisions are actually made. The paper provides a comparative, historical analysis of the key difference between product- and process-based risk governance in the USA, the EU, and India. Through the use of case studies with global significance like MON810 maize, Bt Brinjal, and the April 2024 Philippine Court of Appeals' order for cease-and-desist of Golden Rice, we discuss the increasing tension between administrative scientific approvals and precautionary judicial orders. We further explore the emerging exemptions to regulation of Site-Directed Nuclease (SDN-1 and SDN-2) genome edited crops which led to India's revolutionary 2025 commercialization of climate-resilient rice crops. Our review ends with a forward-looking approach to biotechnology regulation policy, making an appeal to shift from static historical dichotomies towards flexible risk-proportionate and internationally coordinated regulatory systems. Finally, we show that global success of agricultural biotechnology is not just about safety verification, but rather about establishment of transparent and communicable institutions that can transform scientific risk assessments into legitimate risk management decisions.

Plants, Genetically Modified

Initiation into intravenous drug abuse.

At the Stockholm Police Arrest Centre, 156 intravenous drug abusers (103 men, 53 women) were interviewed during the first part of 1987. A structured questionnaire was used in order to survey the initiation process into drug abuse, focusing on the differences and similarities between men and women. Of the men, 80 (78%) had been introduced to illegal drugs by a man and only 14 (14%) by a woman. Of the women, 39 (74%) had been introduced by a man and only 11 (21%) by a woman. The majority of both the men (62%) and the women (51%) were introduced by a close friend. Most of the introductions took place in a secure environment, at the home of either the novice, a friend or the introducer.

Adolescent

[Poverty on the psychiatric unit--a central problem in mental health treatment].

72 patients of the psychiatric department of the general hospital in Berlin Neukölln were interviewed unselectedly to the subjects of lodging and income with the help of a semistructured interview. Only 16 (22%) patients still had a job, 17 (24%) were without job and 31 (43%) were on pension. 10 patients (14%) were homeless, 12 patients (17%) lived in insufficient conditions of housing. Only 11 patients (15%) earned their own wage/salary. All together 25 patients (36%) were in some way dependent on support by social security. Half of the patients had a regular income of less than DM 1000.--a month. The everyday dealing with the problem of poverty on the ward is pointed out and discussed. Obviously this theme is not integrated enough in the therapeutic process. This subject can not only be delegated to the responsibility of the social worker.

Adult

[Immigrants in Switzerland: possibilities and difficulties of integration].

Immigrants find it hard--although not all in the same way--to adapt to the language, the social structure and the way of life of their host country. Different factors overlap: the foreigners' social and cultural background, their education and their adaptability to a foreign environment, their plans for the future, the political and legal situation in the host country as well as the local population's acceptance of and tolerance and respect for a foreign culture. The fact that 75% of all foreigners in Switzerland possess a residence permit can be considered as rather positive; however, this does not necessarily mean that these people are familiar with the local language and way of life. Isolation and a continuously postponed return to the home country are conditions well known even among resident foreigners. Seasonal workers, on the other hand, feel great uncertainty and concern. In critical life situations, for instance caused by illness, accidents or unemployment, the process of rehabilitation can strongly be influenced by earlier living conditions. The Swiss legislation on foreigners as well as the legislation on social security can often bring about fundamental fateful questions. In order to find efficient solutions to the wide range of possible difficulties, a whole-hearted interdisciplinary cooperation is extremely important.

Acculturation

Medical informatics and health care organizations.

A dialogue between upper management and operational elements over an organization's informatics policies and procedures could take place in an environment in which both parties could succeed. Excellent patient care practices can exist in organizational settings where upper management is not concerned with the specifics of the medical care process. But as the medical care process itself becomes costly, complex, and part of the purview of upper management, solutions to ambiguous informatics policies and practices need to be found. As the discussion of cost determination suggests, a comprehensive "top-down" solution may not be feasible. Allowing patient care expertise to drive the design and implementation of clinical computing modules without unduly restrictive specifications from above is probably the best way to proceed. But if the organization needs to know the specifics of a treatment episode, then the informatics definitions specific to treatment episodes need to be unambiguous and consistently applied. As the discussion of Social Security numbers suggests, communication of information across various parts of the organization not only requires unambiguous data structure definitions, but also suggests that the communication process not be dependent on the content of the messages. Both ideas--consistent data structure definitions for essential data and open system communication architectures--are current in the medical informatician's vocabulary. The same ideas are relevant to the management and operation of large and diffuse health care enterprises. The lessons we are learning about informatics policy and practice controls in clinical computing need to be applied to the enterprise as a whole.

Costs and Cost Analysis

[Changes in clinical, hematologic and biochemical indicators in controlled respiration during anesthesia in dogs].

Some clinico-biochemical parameters were investigated in fifty clinically healthy dogs in the course of controlled breathing in halothane inhalation anaesthesia to evaluate in a complex manner the dynamics of metabolic processes in the dog organism. The test dogs were divided into three groups. In the first test group, ECG and values of acid-base balance parameters in venous blood were followed in ten dogs. In the second test group, the values of blood gases were followed in addition to the above-mentioned parameters in twenty anesthetized dogs. In the third test group comprising twenty animals, acid-base parameters in arterial blood and blood gas tension were evaluated. Greatest divergences were recorded in pH values, blood gas tension and acid-base balance values. Partly compensated respiration acidosis was observed already in 30 minutes from the start of anaesthesia, as shown by complex evaluation. The results indicate that also in optimum ventilation programme it is necessary to apply infusion solutions to the internal environment of organism which will secure metabolic rebalancing in the course of artificial pulmonary ventilation.

Anesthesia, Inhalation