E-health 3

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• Question: What are Notified Bodies in the context of EU MDR? Notified Bodies are private, independent organizations designated by EU member states to assess the conformity of medical devices with the Medical Device Regulation (MDR).
• Question: What is the role of Notified Bodies? They evaluate whether a device meets the regulatory requirements for safety, performance, and effectiveness. If successful, the device receives a CE mark, allowing it to be sold in the EU.
• Question: What are the concerns and conflicts of interest regarding Notified Bodies? Companies pay Notified Bodies for evaluation, potentially creating a conflict of interest as Notified Bodies might feel pressured to approve devices to retain clients.
• Question: How does the MDR address "switching bodies"? Under the MDR, there is a trace of previous negative assessments, preventing manufacturers from shopping around for easier approvals.
• Question: How is classification determined for software connected to a medical device? The classification follows the higher risk class of the connected device. For example, if software falls under Class I but the connected device is Class IIa, both are classified as Class IIa.
• Question: What are the risk classes for medical devices under MDR? Class I (Low Risk): Minimal risk, e.g., bandages, stethoscopes. Class IIa (Medium Risk): Moderate risk, short-term use, e.g., dental fillings, hearing aids. Class IIb (Higher Risk): Higher risk, long-term or critical use, e.g., ventilators, infusion pumps. Class III (High Risk): Highest risk, implantable or life-sustaining, e.g., pacemakers, heart valves.
• Question: What is Rule 15 in medical device classification? Rule 15 applies to devices used for contraception or prevention of sexually transmitted diseases. For example, contraception software is classified as Class IIb.
• Question: How does classification in medical guidelines differ from medical device classification? Medical guidelines classify procedures or treatments based on risk/benefit and evidence level. This classification is not specific to devices and serves as recommendations, not laws.
• Question: Why is evaluating digital health solutions challenging? Digital health solutions require multi-dimensional evaluation methods due to their complexity. Their effectiveness is measured through engagement and behavioral changes, not direct effects like drugs.
• Question: What are the approaches to validate digital health solutions? alidation requires multi-dimensional methods and frameworks, such as: Multiphase Optimization Strategy (MOST) to test multiple interventions simultaneously. N-of-1 studies for individualized testing.
• Question: What is treatment adherence? Treatment adherence refers to the extent to which patients take their medications as prescribed. It has always been a challenge due to various patient and system-related factors.
• Question: What are the factors in the Social/Economic category affecting adherence? Age, literacy, and socioeconomic status.
• Question: How do Social/Economic factors affect adherence? Low literacy results in poor understanding of medication importance, especially for chronic conditions with no immediate benefits.
• Question: What are the factors in the Patient-Related category affecting adherence? Forgetfulness, treatment anxiety, and lack of motivation.
• Question: How do Patient-Related factors affect adherence? Patients may misunderstand instructions or lack motivation to follow long-term therapies.
• Question: What are the factors in the Therapy-Related category affecting adherence? Therapy complexity, side effects, and changing regimens.
• Question: How do Therapy-Related factors affect adherence? Frequent therapy changes (e.g., anticoagulant doses) and side effects discourage patients from continuing treatment.
• Question: What are the factors in the Condition-Related category affecting adherence? Comorbidities such as depression, drug/alcohol abuse, and severity of the condition.
• Question: How do Condition-Related factors affect adherence? Mental health conditions, like depression, reduce motivation to follow treatment plans.
• Question: What are the factors in the Healthcare System category affecting adherence? Poor patient-provider relationships, overworked healthcare providers, lack of follow-up, and lack of incentives.
• Question: How do Healthcare System factors affect adherence? Physicians often lack time to ensure adherence, and patients lack tangible incentives to continue treatments.
• Question: What is White Coat Adherence? White Coat Adherence refers to patients taking medications just before appointments to appear compliant.
• Question: What is pharmacoepidemiologic (secondary database analysis)? It involves using secondary databases (e.g., insurance or electronic records) to infer adherence information for a group of patients, not individuals. This method helps assess potential drug intake over a period without direct measurements.
• Question: What are the potential data sources for secondary adherence analysis? Insurance databases, restricted coverage records, clinical data, EHRs, registries, and population-based administrative data.
• Question: What are the potential research aims of secondary adherence analysis? To characterize adherence. To estimate the association between adherence and other outcomes. To adjust for adherence while estimating other parameters.
• Question: What is refill adherence? Refill adherence assumes that prescription refilling reflects medication-taking behavior. However, patients may refill prescriptions but not take the medication as prescribed.
• Question: What is the Medication Possession Ratio (MPR)? MPR measures adherence by calculating the proportion of days a patient possesses medication within a specific period.
• Question: What is the limitation of patient-kept diaries in measuring adherence? Patient-kept diaries often overestimate adherence by about 30% compared to methods like MEMS data.
• Question: How are patient interviews used to measure adherence? Patients are asked to estimate their medication-taking behavior (e.g., % of missed doses). Healthcare professionals then evaluate these responses to determine adherence levels.
• Question: What is motivational interviewing in adherence measurement? A patient-centered approach combining adherence measurement and intervention to resolve ambivalence and encourage behavioral change. It outperforms traditional advice-giving but requires significant time and physician competence.
• Question: What is the Morisky 8-item Medication Adherence Scale (MMAS-8)? A validated tool for assessing medication adherence, commonly used for hypertension patients.
• Question: What are common hypertension medications? Diuretics: Remove excess sodium and water to lower blood pressure. ACE inhibitors: Relax blood vessels by blocking hormone-induced narrowing. Calcium channel blockers: Relax blood vessels by preventing calcium entry into cells. Beta-blockers: Lower heart rate and the force of heartbeats.
• Question: What are some attempted solutions for non-adherence? Refill reminder programs. Auto-refill programs. E-prescribing. Reducing costs for chronic medications. Pharmacist-provided medication therapy management (MTM). Patient education and communication materials.
• Question: What is Medication Therapy Management (MTM)? A pharmacist-led service helping patients manage medications effectively through: Medication review, personalized plans, counseling, and coordination with healthcare providers.
• Question: What is intentional non-adherence? Patients may rationally choose not to adhere to treatments. The focus is on guiding and motivating patients to voluntarily change behavior using design and persuasion strategies.
• Question: What is the OODA Loop in decision-making? A feedback loop involving: Observe: Gathering information. Orientate: Relating the information to one's context. Decide: Evaluating options. Act: Taking action based on the decision.

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