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- De Maria, Carmelo, et al.
(författare)
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Safe innovation : On medical device legislation in Europe and Africa
- 2018
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Ingår i: Health Policy and Technology. - : ELSEVIER SCI LTD. - 2211-8837 .- 2211-8845. ; 7:2, s. 156-165
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Tidskriftsartikel (refereegranskat)abstract
- Objectives: The principal motivation for regulating medical devices is to protect patients and users. Complying with regulations may result in an increase in development, manufacturing and service costs for medical companies and ultimately for healthcare providers and patients, limiting the access to adequate medical equipment. On the other hand, poor regulatory control has resulted in the use of substandard devices. This study aims at comparing the certification route that manufactures have to respect for marketing a medical device in some African Countries and in European Union. Methods: We examined and compared the current and future regulations on medical devices in the European Union and in some countries in Africa. Contextually we proposed future approaches to open design strategies supported by emerging technologies as a means to enhance economically sustainable healthcare system driven by innovation. Results: African medical device regulations have an affinity to European directives, despite the fact that the latter are particularly strict. Several states have also implemented or harmonized directives to medical device regulation, or have expressed interest in establishing them in their legislation. Open Source Medical Devices hold a great promise to reduce costs but do need a high level of supervision, to control their quality and to guarantee their respect for safety standards. Conclusion: Harmonization across the two continents could be leveraged to optimize the costs of device manufacture and sale. Regulated open design strategies can enhance economically sustainable innovation. (C) 2018 Fellowship of Postgraduate Medicine.
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- Ericson, Lisa, et al.
(författare)
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Stakeholder consensus on the purpose of clinical evaluation of electronic health records is required
- 2017
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Ingår i: Health Policy and Technology. - : Elsevier. - 2211-8837 .- 2211-8845. ; 6:2, s. 152-160
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Tidskriftsartikel (refereegranskat)abstract
- ObjectiveTo explore the purpose and performance of clinical evaluation of electronic health records (EHRs) among stakeholders in order to identify any need for regulatory actions or guidelines.MethodsThis was a qualitative study of information collected in semi-structured interviews (n=28) of representatives of the five largest EHR vendors in Sweden, healthcare provider IT managers, users, and representatives of national authorities.ResultsWe found a difference between the stated purpose of clinical evaluation of EHRs by the authorities and the perception of the purpose by the vendors, IT managers, and the users. The respondents gave divergent answers about the medical purpose of the application: e.g. availability of data, overview and documentation, patient safety, process efficiency, decision support, a working tool, and an aid to communication and follow-up. Several vendors found it difficult to put the term clinical evaluation in its specific context, instead referring to literature reviews, risk analyses, risk-management processes, acceptance tests, test facilities, pilot tests, and proven experience.ConclusionsStakeholders need to agree on a mutually acceptable, consistent method to guide regulatory decisions. The lack of consensus regarding the purpose and performance of clinical evaluation of EHRs could impact negatively on a safe and efficient documentation in healthcare. Thus, there is a need for more consistent use of terms and concepts in, and a more systematic approach to, clinical evaluation of EHRs. To ensure that the implementation of IT in healthcare meets expectations, delivers the desired outcome, and does not create new problems, it should be evaluated.
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- Essén, Anna, et al.
(författare)
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Patient access to electronic health records : Differences across ten countries
- 2018
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Ingår i: Health Policy and Technology. - : Elsevier. - 2211-8837 .- 2211-8845. ; 7:1, s. 44-56
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Tidskriftsartikel (refereegranskat)abstract
- Abstract: Patient-accessible electronic health records (PAEHRs) are being implemented at international scale. Comparing policies and systems could allow countries to learn from each other to address global and nation-specific challenges. We compare national PAEHR policy (hard and soft regulation) and services in 10 countries.Methods: PAEHR policy and system documentation was gathered from Australia, Denmark, Estonia, Finland, France, the Netherlands, New Zealand, Norway, Sweden and the United States. A basic analytic model for policy analysis was used to delimit our focus to policy content, followed by an inductive thematic analysis across countries, in which we clustered initial themes into a set of categories of PAEHR service “approaches” related to three specific content areas.Results: Although all 10 countries ensured some patient rights to access medical records, policies and systems were highly variable, as were the technological processes arising from these. In particular, three policy areas showed great variability. Depending upon country of origin, a patient would encounter differences in: login procedures (security), access to own and other patients’ data during adolescence (user rights), and types of medical data made available to the patient (data sets).Conclusions: Individuals encounter very different access rights to their medical data depending on where they live. Countries may be able to develop improved policies by examining how other nations have solved common problems. Harmonizing policies is also an initial step likely to be needed before cross-national PAEHRs could be possible.
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| 7. |
- Kavaliunas, Andrius, et al.
(författare)
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Swedish Policy Analysis for COVID-19
- 2020
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Ingår i: Health Policy and Technology. - : Elsevier BV. - 2211-8837 .- 2211-8845. ; 9:4, s. 598-612
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Tidskriftsartikel (refereegranskat)abstract
- Introduction: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has challenged health care systems and put societies to the test in the world beyond expectations.Objective: Our aim is to describe and analyze the Swedish approach in combating the pandemic.Methods: We present and discuss data collated from various sources - published scientific studies, pre-print material, agency reports, media communication, public surveys, etc. - with specific focus on the approach itself, Covid-19 trends, healthcare system response, policy and measures overview, and implications.Results: The main intervention to manage the curve has been the general recommendations to adhere to good hand hygiene, beware of physical distance to others, to refrain from large gatherings and restrain from non-essential travel. Persons with suspected Covid-19 infection were recommended to stay at home and avoid social contacts. Additionally, visits to the elderly care homes and meetings with more than 50 people were forbidden. As a result, the healthcare system in the country has so far, never been overwhelmed. However, the relatively high mortality among the elderly, together with the vulnerability of some migrants, points out the drawbacks.Conclusions: Many countries have both marvelled and criticized the Swedish strategy that is formed in a close partnership between the government and the society based on a mutual trust giving the responsibility to individuals. It already highlights how much can be achieved with voluntary measures (recommendations) something that was noticed and proposed as a future model by the World Health Organization. (c) 2020 Fellowship of Postgraduate Medicine.
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