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How smartphones completely disrupt the medical field: an application you must know!
With the rapid development of technology, smartphones are no longer just communication tools, but have become important partners in the medical industry.The popularity of medical software and its integration with mobile devices are changing the entire medical ecosystem.From simplifying medical record management to providing instant health monitoring, the application potential of smartphones is endless.
The application of smart phones is aiming to integrate health information and provide users with more efficient self-management methods.
History of medical software
The use of medical software can be traced back to the 1960s, when Lockheed began considering the first medical information processing system.With the development of computer technology, the concept of medical software became increasingly popular in the 1970s and 1980s.Entering the 1990s, with the rapid progress in the fields of nuclear medicine, cardiology and medical robots, the importance of medical software in medical equipment has also become increasingly prominent.
Smart Medical Equipment and Applications
The rise of smartphones has led to the birth of thousands of medical-related applications that operate in a standardized gray area.In the past, software embedded in devices has been regulated, while medical software separated from hardware has often been ignored in supervision.The U.S. Food and Drug Administration (FDA) finally released new guidelines on "Mobile Medical Applications" in 2011, which covers applications such as the ability to regulate pacemakers and analyze cancer images.
"Any software that complies with the legal definition of medical equipment is considered a medical equipment software."
Classification of medical equipment software
Medical software can be classified multiplely based on technical nature (embedded devices or standalone software), safety level (from unimportant to safety critical), or major functions (therapy, education, diagnosis, and data management).Among them, one important distinction is "embedded medical device software (SiMD)" and "software as medical devices (SaMD).SiMD is the core software required for the normal operation of the device, while SaMD is a software that operates independently of the hardware.
The relationship between smartphones and SaMD
With the popularity of smartphones, "Software as Medical Devices (SaMD)" has begun to flourish.Many medical applications operate independently and provide diagnostic and therapeutic functions.While the FDA's initial guidelines attracted industry attention, Congress began to express concerns about the future use of these applications in late 2013.
"First, countries should establish a common framework for SaMD to cope with the growing demand for medical software."
Current international standards and laws
IEC 62304 has become the benchmark for the development of medical device software, whether standalone or embedded software.To ensure safety and effectiveness, software development and maintenance must comply with international standards.The US FDA's quality system regulations and ISO 13485:2016 also put forward high standards for the design and manufacturing of medical equipment software.
Conclusion
With the maturity of smartphones and the advancement of medical technology, the future medical model will rely more on digital solutions.Whether it is patient self-management of health or doctors’ remote diagnosis and monitoring of the disease, these functions will depend on a variety of increasingly advanced software applications.Will the rapid development of technology prevent us from over-reliance on traditional medical care, or will we still have to face new challenges and possible hidden worries?
