The old traditional methods of diagnosis, treatment and prevention have certain drawbacks such as late detection of non-symptomatic diseases, lesser scientific data, slow treatment, lack of effective strategies available, etc. Thus, this traditional method is overcome by modern age digital health in healthcare sectors; and its results and remarkable. The modern age digital health tools such as mobile health, information technology, telemedicine, wearable devices, etc. have added a remarkable dimension to healthcare sector.
Digital Health Role In Regulatory Affairs
Digital health is to maintain privacy and safety in the data that is stored in the system and to provide limited access to it to the authorized people only, that is where the emergence of digital health takes place.
Global Regulatory Framework For Digital Health:
The global regulatory bodies work in the field of digital health to maintain the safety, efficacy, privacy of the patients using digital health tools such as telemedicine, mobile health apps, AI diagnosis tools, virtual diagnosis tools, etc.
Thus, certain regulatory bodies set a set of standards and guidelines for the areas where they are in force for digital health product approval and for the efficient smooth running of digital health systems.
Some of the regulatory bodies and their standards are discussed below:
US FDA:
FDA enforces regulations for digital health regulations in US which always aims at innovation.
FDA digital health policies are thus set in for the efficient working of didgital healthcare tools.
SaMD:
SaMD (Software as Medical Device) is a digital tool used in the US for the diagnostic and treatment purpose which is regulated by the FDA.
SaMD is classified by FDA based on the risk level; which is as followed:
Class I: Low risk devices
It involves digital tools such as mobile health apps, wellness apps, etc.
Class II: Moderate risk devices
This category involves digital tools which involve monitoring of chronic disease.
Class III: High risk devices
This class includes digital tools of high risk such as software that involves decision making of critical conditions and chronic diseases treatment decision.
FDA regulates the use of mobile apps in healthcare by laying down a set of regulations for telemedicine.
The FDA’s digital health innovation action plan is a part of Curse Act.
IMDRF:
IMDRF stands for International Medical Device Regulation Forum.
It regulates the working of software SaMD which is an US based digital software.
IMDRF provides approval for the use of SaMD.
It helps in evaluation of digital tools used in SaMD as low risk, moderate risk and high-risk tools.
EU:
The EU is a regulatory body enforced in European countries, which investigates the rules and regulations for digital health technologies. It involves Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) which involves the regulation for medical devices as well digital health tools.
The MDR classifies the healthcare digital tools as follows:
Class I: Low risk devices
It involves low level apps, trackers, etc.
Class II A and II B: Moderate risk devices.
This class includes moderate risk tools which as used in chronic diseases.
Class III: High risk devices:
This category consists of high-risk software used in healthcare.
3. WHO:
WHO is a global organization that investigates the healthcare sector all over the world.
It has also laid a set of standards for global use of digital healthcare tools.
“Global Strategy on Digital Health” is one of the initiatives by WHO.
OECD:
OECD is Organization for Economic Co-operation and Development) which works globally to monitor the healthcare sector, it provides a set of standards and guidelines for the use of digital tools in healthcare sector.
They have set guidelines for the approval and use of digital tools globally.
For telemedicine it provides guidelines as to who can access the data, how reimbursement will take place, etc.
For AI based healthcare models it provides guidelines for ethical standards an AI model should maintain, data governance, etc.
OECD has collaborated with Health Technology Assessment (HTA) for efficient monitoring of digital tools and their safety.
AI In Healthcare Digital Technology:
AI in healthcare compliance has opened new doors of technology in every field, and its innovation in the healthcare sector has proven its ability to make the healthcare process quick and easy for the doctor as well as the patient.
AI has introduced many digital tools such as mobile trackers to trac the patient health, schedule reminders for the patient visits, suggest health tips for patients, solve the doubts of patients in any aspects, be a virtual doctor to the patient always, etc.
And the emergence of a new AI driven digital tool that is computer vision is trained to read the X-ray and scan reports with the help of AI algorithm.
It also helps in the study of data from large volumes of patient reports.
AI reduces human errors and makes it simple to repeat a task thus, eventually reducing the patient cost.
Overall, AI improves patient health by improving diagnosis and treatment.
Cybersecurity Compliance For Digital Health Devices:
The emergence of this innovative digital healthcare technology has led to the discovery of new ways of patient treatment and prevention. However, as every coin has two sides, so as this digital healthcare tools have. As they have let in many cybersecurity issues challenging the professionals, patients and developers.
This endangers the confidential information of the patients. However, there are some regulations made by certain regulatory bodies or organizations which work for cybersecurity for digital health devices in the healthcare sector. They are as follows:
Cybersecurity Assurance Program (CAP): The CAP is designed for manufacturers and patients to provide privacy and confidentiality and to provide cybersecurity to the end users. It is based on the UL 2900 series.
HIPAA: The Health Insurance Portability And Accountability Act (HIPAA) laid down a set of standards for protecting Patient Health Information (PHI).
ISO 14971: It also provides guidelines for medical device management.
FD and C Act: Section 523B(b)(2) of the FD and C Act provides details of the requirements of digital healthcare tools to ensure cybersecurity.
FAQ’s:
How digital health is regulated by the FDA?
Digital health is regulated by FDA by programme like SaMD, AI tools, Digital Health Center of Excellence, cybersecurity standards, etc.
What are the challenges encountered by digital health regulatory compliance?
The major challenges encountered by digital health regulatory compliance are handling varying global regulations, ensuring cybersecurity, validating AI models, and adhering to real-world data usage guidelines.
What is the role of cybersecurity in digital health regulations?
The safety and privacy of medical device data, with standards like IEC 62304 guiding compliance is ensured by cybersecurity.
What are the global differences that exist in digital health regulations?
Global differences occur according to the regional requirements such as FDA and EU focus on SaMD requirements; while Asian Pacific regions focus on telemedicine and mobile health.
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