Healthcare data includes technologies and systems used for creating health information that is accessible to patients and healthcare providers. It allows doctors to access vital patient information and enables hospitals and other physicians to protect patient data and build trust with patients.
Telehealth is the use of technology to provide services such as consultations, diagnosis, treatment, and remote monitoring. It has emerged as a prominent trend in healthcare over the years and was especially relevant during the outbreak of COVID-19. The telehealth sector is thriving today, and it is expected to grow in the coming years.
In the fast-moving realm of medical device documentation, precise and clear communication is essential, along with adherence to Regulatory standards. Embracing the Darwin Information Typing Architecture Extensible Markup Language (DITA XML) can revolutionize how you create, organize, and distribute vital information. To create technical content, you need to keep in mind some key pointers that will help you optimize your information.
In the ever-evolving world of healthcare, the development and introduction of new medical devices play a pivotal role in enhancing patient care and advancing medical science. However, before such innovative devices can reach healthcare professionals and patients, they must achieve compliance with a comprehensive Regulatory framework. In India, securing a manufacturing or import license for new medical devices is a multifaceted process that involves compliance with stringent rules and regulations.
Pharmaceutical businesses looking for new business prospects find South Korea to be an attractive market with a fast-increasing pharmaceutical industry. With over nine-hundred (900) new drugs in the pipeline and exports totalling USD 3.1 billion, South Korea provides enormous potential for big pharma manufacturing.
The European medical devices market, being the second largest in the world, is majorly driven by a growing patient population, technological advancements, and increasing healthcare expenditure. However, when it comes to expanding the medical device business into the European geography, a complex web of regulations and recent geopolitical changes adds an extra layer of challenge.
The biggest challenge that creative medical device Research and Development (R&D) programs face is that of balancing clinical evidence with early patient access. To address this, a new review system was proposed in Japan, to pace up device clearance while maintaining safety and efficacy. This benefits patients who are inflicted with life-threatening diseases that lack effective treatments.
As technology continues to advance, so do the medical devices that are used to sustain life. While in South Korea, various types of medical devices capable of communication have been developed, the development is accompanied by the risk of cybersecurity threats such as hacking of medical devices and information leaks. These threats are not only applicable to property loss, but also to patients’ lives, and that is why safeguarding medical device cybersecurity is a core concern.
Software as a Medical Device (SaMD) is an emerging category of medical devices that has been experiencing rapid growth in recent years. This category of devices includes medical device software applications designed for medical purposes, such as diagnosis, disease prevention, treatment, and monitoring.
Medical device classification with the Ministry of Health and Prevention (MOHAP) in the United Arab Emirates (UAE) is vital for ensuring patient safety, achieving Regulatory compliance, and determining registration requirements. The classification is risk-based, with four (04) types (Class I, IIa, IIb, and III), and is overseen by MOHAP’s Registration and Drug Control Department. It ensures compliance, streamlines registration, and safeguards public health.