Difference between revisions of "MHealth Regulation"

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== Background ==
 
== Background ==
The Food and Drug Administration (FDA) [http://http://www.fda.gov/ FDA] first issued draft guidance  "Policy for the Regulation of Computer Products" in 1989<ref name="wiki1989">[http://itlaw.wikia.com/wiki/FDA_Policy_for_the_Regulation_of_Computer_Products IT Law Wiki Page on 1989 draft policy]</ref><ref name="FDA2015">[http://www.fda.gov/downloads/MedicalDevices/.../UCM263366.pdf 2015 Mobile Medical Applications: Guidance for Industry and Food and Drug Administration Staff - issued February 9, 2015]</ref>.  The guidance was never finalized and instead retracted in 2005<ref name="wiki1989" /><ref name="FDA2015" />.  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<ref name="FDA2015" />.  The FDA later issued specific guidance for [[MHealth]] applications on September 25, 2013 which has been replaced by updated guidance on February 9, 2015<ref name="FDA2015" />.
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The Food and Drug Administration (FDA) [http://http://www.fda.gov/ FDA] first issued draft guidance  "Policy for the Regulation of Computer Products" in 1989<ref name="wiki1989">[http://itlaw.wikia.com/wiki/FDA_Policy_for_the_Regulation_of_Computer_Products IT Law Wiki Page on 1989 draft policy]</ref><ref name="FDA2015">[http://www.fda.gov/downloads/MedicalDevices/.../UCM263366.pdf 2015 Mobile Medical Applications: Guidance for Industry and Food and Drug Administration Staff - issued February 9, 2015]</ref>.  The guidance was never finalized and instead retracted in 2005<ref name="wiki1989" /><ref name="FDA2015" />.  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<ref name="FDA2015" />.  The FDA later issued specific guidance for [[MHealth]] applications (apps) on September 25, 2013 which has been replaced by updated guidance on February 9, 2015<ref name="FDA2015" />. 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."<ref name="FDA2015" />
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== [[MHealth]] Apps defined ==
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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)<ref name="FDC">[http://www.fda.gov/RegulatoryInformation/Legislation/FederalFoodDrugandCosmeticActFDCAct/FDCActChaptersIandIIShortTitleandDefinitions/ucm086297.htm Section 201 of FD&C Act]</ref> 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."<ref name="FDA2015" />.  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<ref name="FDA2015" />.
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== Regulated [[MHealth]] Apps  ==
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Mobile 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.
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Mobile apps that 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.
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== [[MHealth]] Applications defined ==
 
The FDA guidance describes regulated applications as "meets the definition of device in section 201(h) of the Federal Food, Drug, and Cosmetic Act (FD&C Act)<ref name="FDC">[http://www.fda.gov/RegulatoryInformation/Legislation/FederalFoodDrugandCosmeticActFDCAct/FDCActChaptersIandIIShortTitleandDefinitions/ucm086297.htm Section 201 of FD&C Act]</ref>< 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."<ref name="FDA2015" />. 
 
  
 
== Exemptions ==
 
== Exemptions ==

Revision as of 04:30, 30 April 2015

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

Mobile 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. Mobile apps that 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.


Exemptions

References

  1. 1.0 1.1 IT Law Wiki Page on 1989 draft policy
  2. 2.0 2.1 2.2 2.3 2.4 2.5 2.6 2015 Mobile Medical Applications: Guidance for Industry and Food and Drug Administration Staff - issued February 9, 2015
  3. Section 201 of FD&C Act

Submitted by (Eric J. Vinson)