E-health 2

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• Question: What are the barriers to e-health implementation? Lack of financial incentives, Lack of stakeholder support, Cultural, organizational, and psychological factors, Legal issues, Lack of standardization, Lack of evidence on cost-effectiveness, Lack of motivation and ability to use technology, Low reach, Non-adherence, Low inter-usability.
• Question: What does "Lack of financial incentives" refer to in e-health implementation? It refers to the challenge of determining who pays for what in e-health initiatives.
• Question: Why is stakeholder support important for e-health? E-health technologies impact the lives and work of many people, often with conflicting interests, making stakeholder support crucial for adoption.
• How do cultural, organizational, and psychological factors act as barriers to e-health? These factors influence the context in which e-health solutions are implemented and must be carefully considered.
• What are the legal issues in e-health implementation? Legal issues often involve a lack of clarity in regulations and standards.
• Why is standardization important in e-health? A lack of standardization leads to different standards and low interoperability among technologies.
• What is the significance of evidence on cost-effectiveness in e-health Evidence is needed to demonstrate that e-health solutions are both effective and cost-efficient.
• Question: What role does motivation and ability play in e-health adoption? Users must be motivated and capable of using e-health technologies effectively.
• Question: What is non-adherence in e-health? Non-adherence refers to many people stopping the use of e-health technologies over time.
• What does low inter-usability mean? It refers to different e-health technologies not communicating effectively with each other.
• Question: What are the challenges in patient-physician communication in digital health? The adoption of digital innovations changes how and when communication happens. Communication via platforms like WhatsApp risks patient privacy and is unsuitable for disclosing medical information. Physician actions must be traceable for accountability.
• Question: What is the issue with lack of reimbursement in digital health? Patients must pay to access technology and services. Physicians are not reimbursed for the time spent managing and interpreting new data.
• Question: Why is specific regulation needed for mHealth? Regulations clarify what is and is not regulated, building trust between patients and doctors. Unregulated tools can lead to patient harm.
• Question: What is the difference between a directive and a regulation? A directive requires countries to adopt it but allows flexibility in implementation. A regulation must be applied uniformly across all countries without deviation.
• Question: What is the definition of a medical device under EU MDR? A medical device is any instrument, apparatus, appliance, material, or software used alone or in combination. It is intended for human use in diagnosis, prevention, monitoring, treatment, or alleviation of disease. The 2017/745 regulation added prediction and prognosis, often associated with machine learning.
• Question: What is the EU MDR (Medical Device Regulation)? The EU MDR introduces new concepts, definitions, classification rules, and procedural requirements for medical devices. Many digital health technologies now fall under its scope.
• Question: What is an active device under EU MDR? An active device depends on a non-human energy source (e.g., electricity) for operation. Software is also considered an active device as it relies on energy sources to function.
• Question: What is an active implantable medical device? It is an active device surgically or medically implanted into the body or through a natural orifice. It is intended to remain in the body after the procedure. These devices are classified as high risk due to potential compatibility and health issues.
• Question: What is the meaning of "Vitro" and "In Vitro"? Vitro: A Latin word meaning "glass." In Vitro: Refers to processes or tests performed outside the living body, typically in a lab, using glass containers like test tubes or petri dishes.
• Question: What is a reagent? A reagent is a substance or chemical used in a reaction to detect, measure, or examine other substances.
• Question: What is a reagent product? A reagent product is a prepared kit or material containing reagents designed for specific diagnostic purposes.
• Question: What is an apparatus? An apparatus is a device or set of equipment used for specific tasks or experiments, such as a microscope.
• Question: Why is it important to understand when software is a medical device? To avoid restrictions or problems when placing the software on app stores. To define the claim, including purpose, target market, and intended use. To ensure compliance with EU regulations to avoid penalties and fraud. To guarantee safety, privacy, and accuracy for the user. To properly enter the certified medical device market sector for potential benefits like tax discounts.
• Question: What are the responsibilities of industry/developers for medical device software? To avoid penalties for false claims or fraud by adhering to regulations. To guarantee safety, privacy, and accuracy of the product by conducting tests and obtaining certifications. To ensure proper entry into the certified medical device market sector.
• Question: What are the responsibilities of physicians regarding medical device software? To avoid liability issues by using approved software in hospitals. To understand the intended use of the software and ensure it impacts clinical decision-making safely.
• Question: What are the responsibilities of patients regarding medical device software? To understand the reliability and accuracy of the software. To distinguish between pranks, lifestyle apps, and certified medical devices.
• Question: What is Medical Device Software (MDSW)? Software intended for medical purposes, either alone or in combination with a device, as defined by the MDR. It includes software driving or influencing medical devices or processing medical information.
• Question: What types of software are exempt from MDR? Software performing basic tasks such as: Storage (e.g., medical databases). Archival (keeping medical records). Communications (transmitting data without interpretation). Simple search (locating information without processing). Basic arithmetic (calculations without medical analysis).
• What is the key criterion for software to be classified as a medical device under MDR? The primary purpose must benefit individual patients by helping diagnose, treat, or monitor their condition.
• Question: What types of software are not considered medical devices under MDR? Software serving public health goals or population-level monitoring, such as tracking COVID-19 cases regionally, even if using medical data.

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