Frequently Asked Questions

FAQ

Can the Reducere technology integrate into my EMR?

〉Currently, the schedule output of this app can be emailed or scanned into any EMR; however, Reducere does not enable individuals to interact with PHR systems or EHR systems.

〉The Reducere technology is an invaluable tool that can protect physicians and patients during the national transition away from opioids. Specifically it provides a definite plan that can be placed in the medical record and can guard against tapering too fast.

〉If you are an administrator of an EMR and interested in making the Reducere technology available to your users please contact: solutions@kardiia.co

Is the Reducere application FDA approved?

〉The Reducere application is not a medical device, does not function as a medical device, nor does it perform medical device functions and therefore FDA approval is not applicable

〉FDA’s oversight applies to mobile applications performing medical device functions (which the Reducere technology does not), such as when a mobile medical application transforms a mobile platform into a medical device (which the Reducere technology does not)

〉The Reducere application is not a “mobile medical app” as it does not meet the definition of a device in section 201(h) of the Federal Food, Drug, and Cosmetic Act and neither is it intended to be used as an accessory to a regulated medical device nor to transform a mobile platform into a regulated medical device

〉The Reducere technology is not for the diagnosis of disease or other conditions, or the cure, mitigation, treatment, or prevention of disease, nor is it intended to affect the structure or any function of the body of man

〉The Reducere application is not intended for use in performing a medical device function

〉The Reducere application is not a mobile application that meets the definition of Medical Device Data Systems as it does not intend to transfer, store, convert format, nor display medical device data

〉The Reducere technology does not perform patient-specific analysis nor provide patient-specific diagnosis, or treatment recommendations. The Reducere application is not similar to nor does it perform the same function as those types of software devices that have been previously cleared or approved.

〉The Reducere technology does not perform sophisticated analysis nor interpret data (electronically collected or manually entered) from another medical device

〉The Reducere technology does / is not: Help patients self-manage their disease or conditions without providing specific treatment or treatment suggestions; Provide patients with simple tools to organize and track their health information; Provide easy access to information related to patients’ health conditions or treatments; Help patients document, show, or communicate potential medical conditions to healthcare providers; Automate simple tasks for health care providers; Enable patients or providers to interact with Personal Health Record (PHR) or Electronic Health Record (EHR) systems; nor Intended to transfer, store, convert format, and display medical device data in its original format from a medical device (as defined by MDDS regulation 880.6310 OUG).

〉The Reducere application is not a mobile application that provides easy access to information related to patients’ health conditions or treatments. The Reducere technology does not provide contextually-relevant information to users by matching patient-specific information to reference information routinely used in clinical practice to facilitate a user’s assessment of a specific patient.

〉The Reducere application does not enable individuals to interact with PHR systems or EHR systems

〉The Reducere application does not collect or transmit any patient-specific information at any time in any way. For additional information please reference: reducere.io/privacy

〉For additional information please reference:
Mobile Medical Applications | Guidance for Industry and Food and Drug Administration Staff

Is the Reducere application HIPPA compliant?

〉The Reducere application does not collect or transmit any personally identifiable information

〉For additional information please reference: reducere.io/privacy

Are there enterprise or corporate solutions available?

〉Yes, corporate interests can contact us at solutions@kardiia.co and customized solutions will be created

〉The Reducere technology is an invaluable tool that can protect physicians and patients during the national transition away from opioids. Specifically it provides a definite plan that can be placed in the medical record and can guard against tapering too fast.

Is the Reducere technology available for addiction recovery facilities?

〉Yes, please contact us at solutions@kardiia.co and customized solutions will be created

〉The Reducere technology is an invaluable tool that can protect physicians and patients during the national transition away from opioids. Specifically it provides a definite plan that can be placed in the medical record and can guard against tapering too fast.

Does the Reducere technology take into account ceiling doses?

〉Yes, the Reducere technology generates the most tolerable and elegant tapering schedules while containing built in safety measures including limits on acetaminophen or other non-opioids with ceiling doses

What if the prescription is a combination of two separate doses of the same medication?

〉In this case, if the doses can be added such that the sum is an existing dosing option, use this dose. If the doses do not add up to an existing option, it is recommended to taper one dose at a time until discontinued or until the doses can be added to equal an existing dose.

〉Future versions of the Reducere technology will include the ability to combine doses

What if the prescription is higher than the highest single dosing option?

〉In this case, if the doses can be added such that the sum is an existing dosing option, use this dose. If the doses do not add up to an existing option, it is recommended to taper one dose at a time until discontinued or until the doses can be added to equal an existing dose.

〉Future versions of the Reducere technology will include the ability to combine doses

Can the Reducere application taper Benzodiazepines?

〉The Reducere technology can be expanded to include any medication and a future version of the application will include Benzodiazepines

I am not a practitioner, can I use the Reducere application?

〉The Reducere application is geared towards practitioners as we know it is vital for physicians to provide their patients the most tolerable, safe, accurate, and easy-to-follow taper schedule for opioid prescriptions

〉You may use the Reducere technology for educational purposes and to initiate the tapering conversation with your provider. However, you may not use Reducere in order to taper yourself off of opioid medications. All adjustments to your prescription must be provided to you by your medical provider.

〉We highly suggest you request your provider use this application beginning with your next prescription. Your provider will then be able to create a taper schedule for the duration of your taper that you may both follow to stay on track and ensure you are taken care of.

Do I have to use the Reducere application in order to apply for the scholarship?

〉In terms of alternative treatments, this is separate from your use of the Reducere application. Reducere is meant for practitioners and the donations are meant for you, the patient.

〉If you are currently seeking alternative treatments as you taper or once you have tapered off your opioid medication you are a candidate for this. Please fill out this Google Form if you are interested: reducere.io/scholarship

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