Risks and benefits associated with the primary functions of artificial intelligence powered autoinjectors.

Objectives: This research aims to present and assess the Primary Functions of autoinjectors introduced in ISO 11608-1:2022. Investigate the risks in current autoinjector technology, identify and assess risks and benefits associated with Artificial Intelligence (AI) powered autoinjectors, and propose a framework for mitigating these risks. ISO 11608-1:2022 is a standard that specifies requirements and test methods for needle-based injection systems intended to deliver drugs, focusing on design and function to ensure patient safety and product effectiveness.

Framework for creating a qualified medical device development tool of autoinjectors.

Objectives: Autoinjectors are pivotal for precise self-administration of medications across a wide range of medical conditions. Nevertheless, the absence of a dedicated Medical Device Development Tool (MDDT) for autoinjectors represents a gap that may result in variations in the quality and regulatory compliance of autoinjectors as components of combination products. This research aim is to utilize the recently introduced Primary Functions outlined in ISO 11608-1:2022 with the title "Needle-based injection systems for medical use.

An Overview About Connected Medical Devices and Their Risks.

Connected medical devices may send and receive orders from other devices or networks, such as the internet. A connected medical device is often equipped with wireless connection, allowing it to interface with other devices or computers. Connected medical devices are becoming more popular in healthcare settings because they provide a variety of advantages, such as quicker patient monitoring and more efficient healthcare delivery.

Patients and Organizations eHealth Services Model.

The current Finnish public hospitals' eHealth services are organization-oriented rather than patient-oriented. Patients remain passive and use eHealth services that are designed by private or governmental organizations. Patients had little or no involvement in that process.

Impact of Class I Software as Medical Devices (SaMDs) on Public Health.

There exist numerous low-risk class I SaMDs with CE marking under European Medical Device Directives (MDD). However, if the manufacturers will make any significant change to these class I SaMDs, the manufacturers shall comply with Medical Device Regulation (MDR) 2017/745 classifications. Class I SaMDs are self-declared without the need for notified body involvement.

Development Towards Patient-Centered eHealth Services in Finland.

The paper analyses the development of public eHealth services from 2014 to 2021 from the patients' point of view. The merits and missing features of the eHealth services were identified with patient interviews in 2014-2015. The list of missing features was again checked against the eHealth services in 2021.