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From the 1960s to the present: How does medical software drive the technological revolution?
The development of medical software can be traced back to the 1960s, when the first computerized information processing systems considered in a hospital setting were developed by Lockheed. With the advancement of computing technology, medical software is not only used for data management, but also expanded for diagnosis and treatment purposes, gradually becoming deeply rooted in the medical industry.
The history of medical software reflects the close connection between technological progress and medical services. From the most basic data management to today's complex diagnostic support systems, the revolutionary impact of medical software cannot be ignored.
By the early 1990s, medical software became more important in specific fields such as nuclear medicine, cardiology, and medical robotics, which triggered further research and legislative attention to "safety-critical" medical software. In particular, the scandal surrounding the Therac-25 radiation therapy device has prompted legislators to review the regulation of medical software.
With the introduction of the global medical device standard IEC 62304, the development and testing requirements for medical software have become clearer. This standard provides a clear framework for the development process of medical device software and emphasizes the importance of software in safe and effective therapies. The U.S. Food and Drug Administration (FDA) also provides guidance in this area to promote reasonable supervision of medical software.
FDA guidance and supervision have greatly impacted the development and innovation of medical software, especially in the availability of electronic health records and clinical data.
In the 21st century, the popularity of smartphones has led to the emergence of a large number of independent health and medical-related applications. Many of these applications have certain regulatory gray areas. Different from traditional medical device software, these independent medical software are called "software in medical devices" (SaMD), attracting the attention of legislators and regulators.
In 2011, the FDA's latest draft guidance on "mobile medical applications" was released, which marked the beginning of the regulation of these medical applications. For example, some important mobile applications include the management of implantable cardiac pacemakers and applications for tumor image analysis, which directly affect the patient's treatment process.
With the implementation of these guidelines, the regulatory environment for medical software has gradually become clearer, allowing developers to better understand how to legally operate their products.
Internationally, IEC 62304 has become the benchmark standard for medical device software development, whether it is stand-alone software or embedded software. The launch of this standard not only promotes innovation and development within the industry, but also improves the quality and safety of medical software. Facing the ever-evolving technological environment, how to ensure innovation without sacrificing patient safety has become an extremely important issue.
Statistics show that with the deepening of understanding of medical software and the development of technology, the market demand for such products has also expanded. Major medical institutions and software manufacturers are gradually realizing that they must adapt to the ever-changing legal framework in order to remain invincible in the competition.
Finally, how will the future of medical technology continue to be driven by software developments? This question is thought-provoking.
