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The Birth of Medical Software: Why It Changed the Future of Healthcare?
The development of medical software began in the 1960s, and with the advancement of computing technology, we have witnessed the digital transformation of the medical field. Today’s medical software is more than just a tool used to reduce paperwork or track patient activity; it includes standalone software systems used for diagnosis or treatment, or even program code embedded in medical devices.
"The use of medical software is rapidly changing the face of healthcare, ushering in a new era of data management and patient care."
Looking back in history, the earliest medical software development can be traced back to Lockheed Corporation in the 1960s, when the concept of hospital information processing systems was already considered. With the widespread use of computing technology in the 1970s and 1980s, software used by medical institutions to manage data and operations became popular. In the 1990s, with the increasing demand in specific fields such as nuclear medicine, cardiology and medical robotics, the security of medical software has also attracted much attention, which was partly affected by the Therac-25 radiation therapy device incident, prompting related The regulation of medical software is an area of intense discussion in the research and legislative communities.
In 2006, the IEC 62304 standard developed by the International Electrotechnical Commission further defined the development and testing process for medical device software. The U.S. Food and Drug Administration (FDA) has also begun providing guidance on regulating software embedded in or used as medical devices. In 2009, with the promotion of the HITECH Act, the United States invested a lot of resources in the application of electronic health records and electronic clinical data.
Definition and Standards of Medical Device Software
According to the global IEC 62304 standard, medical device software is defined as "software systems developed for inclusion in a medical device to be developed, or software designed as a medical device itself." In the United States, the FDA has explicitly stated that "any software that meets the legal definition of a medical device" is considered medical device software. This broad definition allows medical software to be classified according to its technical characteristics (embedded in a device or standalone), security level (from the most minor to the most safety-critical version), or primary function (treatment, education, diagnosis, and data management). Classification.
"The significant growth in medical software reflects the healthcare industry's reliance on technology."
Software as a medical device
Since the 21st century, the use of smartphones has skyrocketed, giving rise to thousands of independent health and medical-related software applications. Many of these apps exist in a regulatory gray area. Although the FDA has begun to regulate software embedded in medical devices, there are certain regulatory loopholes for medical software that is not directly integrated with hardware (called "software as a medical device" or SaMD). In 2011, the FDA issued new guidance on "mobile medical applications" and considered all software to be regulated.
With the rapid development of medical technology, many mobile applications are considered to be potentially subject to this guidance, including monitoring of installed pacemakers, analysis of cancer lesion images, X-ray and MRI examinations, and various human physiological data. Monitoring tools. When the final guidance was issued in 2013, Congress raised concerns about its future application, particularly how it would apply to related legislation that was about to come into effect.
The evolution of international standards
With the development of medical devices and software products, IEC 62304 has become the benchmark standard for medical device software development worldwide. Without increased regulation, many standalone medical software products have also proliferated, prompting changes in regulatory policy in the European Union (through the European Medical Device Directive) and the United States (through multiple FDA guidance documents). Since these standards require medical device manufacturers to carry out necessary product development in accordance with the specifications, many manufacturers also choose to obtain certification from relevant organizations.
"The future of medical software is full of challenges and opportunities. How will it change patient care and medical research?"
Looking to the future
The advancement of science and technology continues to impact the boundaries of traditional medicine, and the birth of medical software has undoubtedly brought profound changes to the future medical industry. With the continuous improvement of new laws, regulations and international standards, the standardization and innovation of medical software will usher in new opportunities. However, in the face of these changes, we must also remain vigilant to ensure that these technologies continue to advance while ensuring patient safety and benefits. How to maintain the quality and safety of medical services in such a changing situation has become a focus of attention from all walks of life.
