Difference between revisions of "MHealth Regulation"
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== Regulated [[MHealth]] Apps == | == Regulated [[MHealth]] Apps == | ||
− | The 2015 FDA guidance provides three distinct classes of [[MHealth]] | + | The 2015 FDA guidance provides three distinct classes of [[MHealth]] apps which require regulation. The FDA guidance they are includes [[MHealth]] apps that: |
− | # | + | # Are an extension of one or more medical devices by connecting to such device(s) for purposes of controlling the device(s) or for use in active patient monitoring or analyzing medical device data.<ref name="FDA2015" /> |
− | # | + | # Transform the mobile platform into a regulated medical device by using attachments, display screens, or sensors or by including functionalities similar to those of currently regulated medical devices. Mobile apps that use attachments, display screens, sensors or other such similar components to transform a mobile platform into a regulated medical device are required to comply with the device classification associated with the transformed platform.<ref name="FDA2015" /> |
− | # | + | # Become a regulated medical device (software) by performing patient-specific analysis and providing patient-specific diagnosis, or treatment recommendations. These types of mobile medical apps are similar to or perform the same function as those types of software devices that have been previously cleared or approved.<ref name="FDA2015" /> |
− | == | + | == [[MHealth]] Apps Potentially Exempt from FDA Regulation == |
− | In addition to the | + | In addition to the uses listed above for regulated apps there are seven types of [[MHealth]] Apps which the FDA will apply discretion in regulating. The 2015 FDA guidance includes [[MHealth]] apps that: |
− | # | + | # Provide or facilitate supplemental clinical care, by coaching or prompting, to help patients manage their health in their daily environment.<ref name="FDA2015" /> |
− | # | + | # Provide patients with simple tools to organize and track their health information.<ref name="FDA2015" /> |
− | # | + | # Provide easy access to information related to patients’ health conditions or treatments (beyond providing an electronic “copy” of a medical reference).<ref name="FDA2015" /> |
− | # | + | # Are specifically marketed to help patients document, show, or communicate to providers potential medical conditions.<ref name="FDA2015" /> |
− | # | + | # Perform simple calculations routinely used in clinical practice.<ref name="FDA2015" /> |
− | # | + | # Enable individuals to interact with PHR systems or EHR systems.<ref name="FDA2015" /> |
− | # | + | # Meet the definition of Medical Device Data Systems. <ref name="FDA2015" /> |
+ | |||
+ | == [[MHealth]] Apps Exempt from FDA Regulation == | ||
+ | There are uses for [[MHealth]] Apps which the FDA has provided guidance that they don't intend to regulate. The 2015 FDA Guidance has exempted the [[MHealth]] apps that are: | ||
+ | # Intended to provide access to electronic “copies” (e.g., e-books, audio books) of medical textbooks or other reference materials with generic text search capabilities.<ref name="FDA2015" /> | ||
+ | # intended for health care providers to use as educational tools for medical training or to reinforce training previously received.<ref name="FDA2015" /> | ||
+ | # intended for general patient education and facilitate patient access to commonly used reference information.<ref name="FDA2015" /> | ||
+ | # automating general office operations in a health care setting and are not intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease.<ref name="FDA2015" /> | ||
+ | # generic aids or general purpose products. These apps are not considered devices because they are not intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease.<ref name="FDA2015" /> | ||
Revision as of 04:54, 30 April 2015
Contents
Background
The Food and Drug Administration (FDA) FDA first issued draft guidance "Policy for the Regulation of Computer Products" in 1989[1][2]. The guidance was never finalized and instead retracted in 2005[1][2]. It wasn't till February 15, 2011 that the FDA issued a regulation regarding computer and software that could transfer, store, display, or convert medical device data[2]. The FDA later issued specific guidance for MHealth applications (apps) on September 25, 2013 which has been replaced by updated guidance on February 9, 2015[2]. From the guidance we understand that the FDA doesn't want to regulate all MHealth applications since the "FDA intends to apply its regulatory oversight to only those mobile apps that are medical devices and whose functionality could pose a risk to a patient’s safety if the mobile app were to not function as intended."[2]
MHealth Apps defined
The FDA guidance describes regulated apps as "meets the definition of device in section 201(h) of the Federal Food, Drug, and Cosmetic Act (FD&C Act)[3] and either is intended: to be used as an accessory to a regulated medical device; or to transform a mobile platform into a regulated medical device."[2]. The intent of an app considered when determining the applicability of regulation as a MHealth app. The MHealth app is designed or marketed to with the ability to perform medical device functions[2].
Regulated MHealth Apps
The 2015 FDA guidance provides three distinct classes of MHealth apps which require regulation. The FDA guidance they are includes MHealth apps that:
- Are an extension of one or more medical devices by connecting to such device(s) for purposes of controlling the device(s) or for use in active patient monitoring or analyzing medical device data.[2]
- Transform the mobile platform into a regulated medical device by using attachments, display screens, or sensors or by including functionalities similar to those of currently regulated medical devices. Mobile apps that use attachments, display screens, sensors or other such similar components to transform a mobile platform into a regulated medical device are required to comply with the device classification associated with the transformed platform.[2]
- Become a regulated medical device (software) by performing patient-specific analysis and providing patient-specific diagnosis, or treatment recommendations. These types of mobile medical apps are similar to or perform the same function as those types of software devices that have been previously cleared or approved.[2]
MHealth Apps Potentially Exempt from FDA Regulation
In addition to the uses listed above for regulated apps there are seven types of MHealth Apps which the FDA will apply discretion in regulating. The 2015 FDA guidance includes MHealth apps that:
- Provide or facilitate supplemental clinical care, by coaching or prompting, to help patients manage their health in their daily environment.[2]
- Provide patients with simple tools to organize and track their health information.[2]
- Provide easy access to information related to patients’ health conditions or treatments (beyond providing an electronic “copy” of a medical reference).[2]
- Are specifically marketed to help patients document, show, or communicate to providers potential medical conditions.[2]
- Perform simple calculations routinely used in clinical practice.[2]
- Enable individuals to interact with PHR systems or EHR systems.[2]
- Meet the definition of Medical Device Data Systems. [2]
MHealth Apps Exempt from FDA Regulation
There are uses for MHealth Apps which the FDA has provided guidance that they don't intend to regulate. The 2015 FDA Guidance has exempted the MHealth apps that are:
- Intended to provide access to electronic “copies” (e.g., e-books, audio books) of medical textbooks or other reference materials with generic text search capabilities.[2]
- intended for health care providers to use as educational tools for medical training or to reinforce training previously received.[2]
- intended for general patient education and facilitate patient access to commonly used reference information.[2]
- automating general office operations in a health care setting and are not intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease.[2]
- generic aids or general purpose products. These apps are not considered devices because they are not intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease.[2]
References
- ↑ 1.0 1.1 IT Law Wiki Page on 1989 draft policy
- ↑ 2.00 2.01 2.02 2.03 2.04 2.05 2.06 2.07 2.08 2.09 2.10 2.11 2.12 2.13 2.14 2.15 2.16 2.17 2.18 2.19 2.20 2.21 2015 Mobile Medical Applications: Guidance for Industry and Food and Drug Administration Staff - issued February 9, 2015
- ↑ Section 201 of FD&C Act
Submitted by (Eric J. Vinson)