Patent Issued for Medical data management system (USPTO 11735298): Fisher & Paykel Healthcare Limited

2023 SEP 12 (NewsRx) -- By a News Reporter-Staff News Editor at Insurance Daily News -- A patent by the inventors Casse, Benjamin Wilson (Auckland, NZ), Darby, Adam John (Auckland, NZ), Hamilton, Mark Samuel (Auckland, NZ), Kuriger, Donald Roy (Auckland, NZ), Lamprecht, Bernhard Florian (Auckland, NZ), Young, Alex (Auckland, NZ), filed on August 15, 2022, was published online on August 22, 2023, according to news reporting originating from Alexandria, Virginia, by NewsRx correspondents.

Patent number 11735298 is assigned to Fisher & Paykel Healthcare Limited (Auckland, New Zealand).

The following quote was obtained by the news editors from the background information supplied by the inventors:

“Field of the Invention

“The present invention generally relates to medical devices. More particularly, the present invention relates to systems for the management of medical device data.

“Description of the Related Art

“In the long term treatment or monitoring of medical conditions, it is common for healthcare systems to handle such conditions on an outpatient basis, e.g. at a residence of a patient rather than at a healthcare facility. To treat or monitor the patient on an outpatient basis, the patient may be prescribed a medical device that she may order from a medical device distributor or manufacturer and use at her place of residence. In many cases, if the patient is covered under a health insurance policy, the cost of the medical device may at least in part be paid or reimbursed by an insurer. In some cases, the cost of the medical device may at least in part be paid or reimbursed by a public healthcare system. The medical device may help the patient manage her medical condition by providing therapy or by obtaining and providing diagnostic data to a physician or healthcare provider. In some cases, the medical device may be given to the patient by a medical device distributor, who may offer the patient the device without immediate compensation, but who may be paid later by the insurer and/or healthcare provider. However, if the patient does not use the medical device on a regular basis to aid in the management of her medical condition, the management of the medical condition may be less effective. To help to ensure that the funds allocated by the insurer and/or healthcare system to at least in part purchase the medical device are well spent, the insurer and/or healthcare system may require the patient to provide evidence of regular use of the medical device. If the patient cannot provide proper evidence of regular use of the medical device, the insurer and/or healthcare system may opt to not subsidize the medical device purchase. The medical device distributor may not be paid and may be forced to repossess the medical device. Additionally, in some cases, if the patient engages in hazardous work or work requiring careful attention to detail, the patient’s employer may require evidence of regular use of the medical device. If the patient cannot provide proper evidence of regular use of the medical device, to reduce the employer’s liability, the employer may be forced to terminate the patient’s employment. Furthermore, if the patient requires a license to engage in the work, the patient’s license to handle the particular line of work (normally issued by a local or state government body) may be rescinded.

“As such, it is important to be able to provide evidence of use of a medical device. This evidence may come in the form of a set of data indicating when and/or how the medical device was used over a period of time. This evidence may be referred to as the evidence of compliance or adherence, and the set of data may be referred to as compliance or adherence data (hereinafter, in this section referred to as evidence of compliance and compliance data, respectively). To both aid the patient in collecting and managing compliance data and reassure the medical device distributor that servicing the patient will result in reimbursement, many medical devices offer compliance data management solutions. In some cases, the medical device may automatically record the compliance data over the time period over which the patient uses the device and upload the data to a removable storage medium. The removable storage medium may be given to a physician, insurer, and/or medical device distributor. In some cases, the medical device may output encoded messages that the patient may manually input into compliance monitoring database, which may be on the internet, on a handheld monitoring device, or elsewhere. In some cases, the medical device may automatically wirelessly transmit compliance data to a compliance monitoring database through the use of wireless data communications technologies.”

In addition to the background information obtained for this patent, NewsRx journalists also obtained the inventors’ summary information for this patent: “Some patients may wish to carry multiple medical devices that may be used interchangeably to treat and/or monitor their medical condition. In some cases, the patient may want a first high-end medical device to treat her condition at home and a second smaller or ‘more travel-friendly’ device to use when away from home for an extended period of time. For example, when considering obstructive sleep apnea (OSA), a patient who is a truck driver may wish to use a high-end positive airway pressure (PAP) device to treat her OSA at home and wish to use a lightweight travel-friendly PAP device to treat her OSA when working or otherwise away from home. However, compliance data management may become more difficult when two or more medical devices are used. In some cases, if the patient uses multiple devices over a given time period, the patient may forget to send compliance data for one or more of the devices and, in such cases, there may be gaps in the compliance data reported to a recipient (e.g., an insurer, a medical device distributor, etc.). In some such cases the patient may have more difficulty providing proper evidence of compliance to the recipient. In some cases, the patient may be forced to send two separate sets of compliance data and the recipient may have the added challenge of manually integrating the two sets of data to compile a single set of accurate compliance data. In either case, the tasks related to compliance data management may become more inconvenient for the patient and/or for the recipient. Accordingly, it is an object of the disclosure to provide improved data management solutions that may solve one or more of the above problems, or at least provide the public with a useful choice.

“In accordance with at least one of the embodiments disclosed herein is a method of integrating data from two or more medical devices comprising: receiving a first data set comprising one or more data entries related to the use of a first medical device, related to the therapy of a patient using the first medical device, and/or related to a patient using the first medical device, each of the one or more data entries being associated with a time and/or a position in a sequence of entries, receiving a second data set comprising one or more data entries related to the use of a second medical device, related to the therapy of a patient using the second medical device, and/or related to a patient using the second medical device, each of the one or more data entries being associated with a time and/or a position in a sequence of entries, and integrating the first data set with the second data set to create a third data set, the integration being such that the third data set comprises the data entries of the first and second data sets.

“In some configurations a report is generated comprising the third data set and/or a function of the data entries of the third data set.

“In some configurations the integration is such that the third data set comprises the data entries of the first and second data sets arranged in a temporal sequence with respect to one another.

“In some configurations the first and second medical devices are PAP devices.”

The claims supplied by the inventors are:

“1. A method of monitoring outpatient use of a plurality of medical devices to promote adherence of a patient to a therapy regime, the method comprising: synchronizing a first clock of a first medical device with a second clock of a second medical device; detecting patient use of at least one of the first medical device and the second medical device; receiving a first data set comprising data from the first medical device; receiving a second data set comprising data from the second medical device, wherein the first data set is obtained from the first medical device over a first time period, and wherein the second data set is obtained from a second medical device over a second time period, and wherein the first data set and second data set are related to the patient’s adherence to the therapy regime; comparing the first data set with the second data set; integrating the first data set and the second data set to create a third data set, wherein the first data set and the second data set are integrated such that the data of the first data set and the data of the second data set are arranged such that the data of the first data set and the data of the second data set are in a temporally sequential order with respect to each another; and generating a report comprising the third data set, wherein the report comprises information summarizing the patient’s adherence to the therapy regime.

“2. The method of claim 1, wherein the report comprises an indicator derived from the first data set and the second data set, the indicator being related to the patient’s adherence to the therapy regime.

“3. The method of claim 2, wherein the indicator is a binary indicator indicating whether the patient succeeded or did not succeed in achieving a level of adherence to the therapy regime relative to a threshold level of adherence.

“4. The method of claim 2, wherein the indicator is a qualitative indicator and is generated by comparing a degree of adherence to one or more threshold or baseline values.

“5. The method of claim 1, wherein the data of the first data set comprises at least one data block associated with time, and wherein the data of the second data set comprises at least one data block associated with time.

“6. The method of claim 2, wherein comparing the first data set with the second data set comprises: checking if the first time period and the second time period are the same; and checking whether any of the data of the first data set has a time stamp that is the same as a time stamp of any of data of the second data set.

“7. The method of claim 1, wherein integrating the first data set and the second data set is executed by an intermediary device, wherein the intermediary device is a medical device or one of a desktop computer, laptop computer, tablet, mobile phone, wearable computing system, or other personal computing device.

“8. The method of claim 1, wherein integrating the first data set and the second data set is executed by at least one of the first medical device or the second medical device.

“9. The method of claim 8, further comprising receiving the second data set by the first medical device from the second medical device or receiving the first data set by the second medical device from the first medical device.

“10. The method of claim 8, wherein integrating the first data set and the second data set is executed by both the first medical device and the second medical device such that each of the first medical device and the second medical device comprise a copy of the third data set.

“11. A system for monitoring outpatient use of a plurality of medical devices to promote adherence of a patient to a therapy regime, the system comprising: a first medical device; a second medical device; an intermediary device configured to communicate with the first medical device and the second medical device, the intermediary device configured to integrate data received from the first medical device and the second medical device, wherein the intermediary device is configured to: receive a first data set comprising data from the first medical device obtained over a first time period, receive a second data set comprising data from a second medical device, obtained over a second time period, and wherein the first data set and second data set are related to a patient’s adherence to a therapy regime, compare the first data set with the second data set, integrate the first data set and the second data set to create a third data set, wherein the first data set and the second data set are integrated such that the data of the first data set and the data of the second data set are arranged such that the data of the first data set and the data of the second data set are in a temporally sequential order with respect to one another, and generate a report comprising the third data set, wherein the report comprises information summarizing the patient’s adherence to the therapy regime.

“12. The system of claim 11, wherein the report comprises an indicator derived from the first data set and the second data set, the indicator being related to the patient’s adherence to the therapy regime.

“13. The system of claim 12, wherein the indicator is a binary indicator indicating whether the patient succeeded or did not succeed in achieving a level of adherence to the therapy regime relative to a threshold level of adherence.

“14. The system of claim 12, wherein the indicator is a qualitative indicator and is generated by comparing a degree of adherence to one or more threshold or baseline values.

“15. The system of claim 11, wherein the data of the first data set comprises at least one data block associated with time, and wherein the data of the second data set comprises at least one data block associated with time.

“16. The system of claim 11, wherein the intermediary device is configured to compare the first data set with the second data set by: checking if the first time period and the second time period are the same; and checking whether any of the data of the first data set has a time stamp that is the same as a time stamp of any of the data of the second data set.

“17. The system of claim 11, wherein the intermediary device is a medical device.

“18. The system of claim 11, wherein the intermediary device is one of a desktop computer, laptop computer, tablet, mobile phone, wearable computing system, or other personal computing device.

“19. The system of claim 11, wherein at least one of the first medical device and the second medical device comprises a PAP device.

“20. The system of claim 11, wherein the first medical device comprises a first communications module and the second medical device comprises a second communication module.”

URL and more information on this patent, see: Casse, Benjamin Wilson. Medical data management system. U.S. Patent Number 11735298, filed August 15, 2022, and published online on August 22, 2023. Patent URL (for desktop use only): https://ppubs.uspto.gov/pubwebapp/external.html?q=(11735298)&db=USPAT&type=ids

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