Analysis of Legal and Regulatory Frameworks in Digital Health: A Comparison of Guidelines and Approaches in the European Union and United States

The advent of digital technology in healthcare presents opportunities for the improvement of healthcare systems around the world and the move towards value-based treatment. However, this move must be accompanied by strong legal and regulatory frameworks that will not only facilitate but encourage the good use of technology. The goal of the study was to assess the amenability and furtherance of regulatory frameworks in digital health by evaluating and comparing the processes, effectiveness and outcomes of these frameworks in the European Union and United States. Methods: This study incorporated two research methodologies. The first was a research of current legal and regulatory frameworks in digital health in the European Union and United States. A comprehensive online search for publications was carried out which included laws, regulations, policies, green papers, guidelines and recommendations. This research was complemented with interviews of five purposively sampled key informants in the legal and regulatory landscape. Results: Mind-maps revealed key features and challenges of the digital health field in the topics of the current state of regulation of digital health in the EU, Germany and US, regulatory pathways for digital health devices, protection and privacy of health data, mobile health validation, risk-based classification of medical devices, regulation of clinical decision support systems, telemedicine, artificial intelligence and emerging technologies, reimbursement for digital health services and liability for digital health products. The experts expressed and explained key points where current regulation is deficient. The review of the legal frameworks revealed deficiencies which provide opportunities and recommendations to further develop and strengthen the regulatory landscape. Conclusions: A key element to a robust regulatory framework is the ability to ensure trust and confidence in using digital health technology. Technology must measure the impact on quality of life and burden of disease and not merely involve the collection of data

From Traditional to Online Methods for Generating Business Ideas

The traditional methods for generating venture ideas are in use for more than 70 years in the business, while the development of information and communication technologies (ICT) opened new opportunities for generating and harvesting business ideas, available to entrepreneurs of any kind. Our initial research discovered that there is a missing link in the academic literature between the traditional and the emerging online methods for generating business ideas and therefore, in this paper, we study the traditional and online sources and methods in parallel. The purpose of our study is to improve the venture idea creation process from an applicable perspective, and to add to the existing ideation literature by (1) identifying and classifying the sources of ideas to create the necessary link between the onsite and online access to idea sources; (2) explaining the traditional methods for generating business idea trough their dominant features in order to (3) further identify and elaborate the online sources and ideation methods trough these features and link them to the known traditional approaches. The sources, methods, and tools we examine and elaborate in this paper could be used for both, generating ideas for traditional and online business models. Hence, our findings have practical and applicable value for the first step in the entrepreneurial process. Additionally, our study could be used as a starting point for further research in the field of online ideation, a field that needs to be yet, more extensively, addressed by practitioners and research scholars

MS

thesisFormal clinical laboratory improvement programs have been seeded by incendiary reports of fraud and error in diagnostic laboratories and the accompanying fear of public outrage. These programs are perpetuated by an intuitive notion that they foster quality health care, and that without them, conditions would be intolerable. The real efficacy of clinical laboratory improvement programs is debatable. When improvements in performance have been documented, the evaluation designs have not supported ironclad causal inferences. This retrospective research examined the technical adequacy of 23 proposed and two completed evaluations of federally funded clinical laboratory improvement programs. The review process used throughout this research is referred to as meta analysis, which is a categorical term that means evaluation of evaluations or evaluation audit. Proficiency testing, technical consultation, and training were the three general approaches to laboratory improvement. A checklist of 31 evaluation guidelines was developed for the purposes of the review and for future use by program directors and funding agencies. The data indicate that federally funded laboratory improvement programs continue to use technically weak evaluations. There were no significant differences in overall technical adequacy between the three types of programs. However, there were significant differences between types of program proposals on 13 of the 31 individual checklist items. Eight of the 13 items were directly related to differences in requirements among the funding agent's three requests for proposals. The results suggest that the funding agent is in the best position to raise the technical quality of laboratory improvement program evaluation so that valid inferences as to program impact can be made and potentially worthwhile programs can be perfected