With the development and advancement of mobile health, people's concerns about the regulation of mobile health applications in the United States have become more serious. These general questions include that the FDA's approval process takes a long time, standards are implemented inconsistently, and the classification model based on risk can hinder innovation, which afflicts developers. As a result of the above problems, breakthrough Medical Equipment has been sold in Europe and South Korea for many years before landing in the United States, which has also prompted the United States to continue to shrink the amount of funds used to support health care in the past few years.
In order to reduce the waiting time of developers and increase the consistency of supervision and implementation, the EU is diversifying regulatory approvals into more accreditation bodies to speed up the approval process. For now, the FDA can significantly expand its existing but somewhat outdated third-party certification programs. In the long run, the FDA should also reassess its own regulatory framework based on risk levels, taking into account patient dependence on software and cost-benefit analysis.
EU: Enlightened and sound
Worldwide, countries that regulate mobile medical applications are more than one in the United States. However, many countries, including China and India, have not begun to explore any form of regulatory issues, and many other countries have temporarily and decisively chosen to relax supervision. In March 2014, South Korea identified Samsung mobile phones with mobile health applications and related functions as medical devices, which was an unfavorable judgment for the regulatory system. At present, the EU is at the forefront of the world in establishing a clear mobile health regulatory framework.
The EU's certification approval process for mobile health applications is widely acclaimed because the EU process has less power and is more efficient than the US. In the case of accreditation, more than 70 accreditation bodies within the EU's mandated member states are subject to review. Once a device has been approved by any one of the agencies, it can be sold throughout the EU. Unlike the United States, the EU does not define a range of equipment that can exercise discretion. In other words, there are two types of medical applications: either one that needs to be regulated or one that is completely exempt from supervision. Because of this, the EU regulates certain equipment more stringently than the United States, but the overall supervision of equipment is still a minority. In the United States, a new device may soon be recognized as a third-level product. In the European Union, the default classification of new products belongs to the first level, unless there is evidence that it is more harmful.
Although the EU's regulatory framework may theoretically jeopardize consumer safety, the actual effect is not the case. In the past five years, the EU has also imposed recalls on certain levels of medical equipment like the United States, but at the same time they have passed the approval process for new medical equipment. As a result, many developers in the mobile health sector have chosen to first release products in the EU and then use this revenue to subsidize the more stringent US regulatory approval process. MIMVista, Samsung Health, Fitbix Flex, and CardioMem, all of which were sold to the US market after years of sales in the European Union.
The United States should take note of the international development and progress in the regulation of mobile health for the following reasons: First, the United States can learn some lessons from the EU model, such as proper execution, decentralization, and selective regulation under what circumstances can stimulate innovation. At the same time, it will not affect the interests of consumers. Secondly, the international standardization of supervision in the past five years is constantly improving, and people have been working hard in this field.
In October 2013, the International Forum of Medical Device Regulatory Authorities agreed to move toward the standardization of medical software in the next five years. The EU has embarked on a more standardized test system and decided to publish a report on the use of electronic devices for health care in 2015 by the European Parliament. This standardization measure can rationalize the approval process and reduce regulatory uncertainty. In view of the fact that it is difficult for us to divide consumers online by geographical location, this regulatory aspect is even more needed in the mobile health field. The current changes in the regulatory arena will not only affect the independent market of each country, but also affect the expectations and prospects of investors in the mobile health sector worldwide.
United States: meticulous, conservative, full of uncertainty
Although international standardization is constantly evolving, the regulation of mobile health applications in the United States is still changing. Members of the US House of Representatives and Senate have drafted a bill to try to completely revise regulations for mobile health applications. The House of Representatives' bipartisan alliance introduced the "Sensible Oversight for Technology which Advance Regulatory Efficiency Act" in October 2013, while the Senate Republican and Independent Alliance was in 2014. The "Preventing Regulatory Overreach to Enhance Care Technology Act" was introduced in the month. The wording of these bills is very similar and the purpose is the same: to limit FDA's regulatory coverage in the mobile health arena.
The bill clarifies the distinction between clinical software, health software, and medical software. In the Act, clinical software is defined as software that is used by professional healthcare providers to provide clinical treatment options. Health software is software that can play a supporting role in the administrative management of health care. In the new law, these two types of software will not be regulated by the FDA. The FDA's focus will shift back to software that can diagnose specific patients. Both bills have been submitted to the relevant subcommittee, and the parliament has indicated that it will continue to debate around FDA regulation.
Given the FDA's previous regulatory history in this area, they are unlikely to completely lose regulatory authority in the mobile health arena in the future. Be aware that the FDA was involved in the regulation of portable medical devices before the invention of smartphones.
At several House hearings, expert witnesses from the application developer community pointed out that they believe the FDA is the best institution to continue to monitor. However, some aspects of the FDA regulatory framework need to be adjusted and improved. In fact, there may be more, not less, government agencies involved in the regulation of mobile health in the future. For example, as the number of applications to be processed by the FDA is increasing, the National Institute of Standards and Technology (NIST) may play a more important role in the implementation of quality control management.
Another area of ​​regulatory change is data confidentiality. Mobile health applications and devices continue to collect valid patient data over time. Moreover, mobile health not only collects more data, but also transfers and stores data online. Developers of portable blood glucose meters, activity recording devices and other data collection software have begun to build online platforms so that consumers can access their health information in a more convenient way. As international efforts to promote interoperability continue to grow, it is also possible to share data information between different applications in the future.
These initiatives have far-reaching implications for promoting people's health, but they also raise concerns and concerns about privacy. Can medical insurance companies get this data? Can potential employers obtain this data? Although the media has not yet reported extensively on this issue, the US government has begun to prepare for these concerns. ONC (National Coordinator's Office of Health Information Technology) has released a series of resources for mobile and health data confidentiality for consumers and device manufacturers, including installation guides for mobile health application device users, data management for consumers. Software and new upgrades for developers.
ONC also encourages the protection of data confidentiality by means of financial incentives. For example, in order to meet ONC's data certification requirements and meet specific government subsidies, medical device manufacturers must demonstrate that they are adequately handling confidential data. However, the regulation of data privacy is mainly focused on recommendation norms and incentives, and there are few guidelines that must be followed. As the discussion of data privacy issues becomes hotter, this situation may change. In the future, data privacy will become a core area of ​​regulation, which involves both legislative and enforcement aspects.
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