Machine learning enabled medical management, including systems and uses thereof

Abstract

Systems, methods, and devices for medical practice management. Such embodiments can allow for communication between a practitioner, patient, caretaker, pharmacist, and / or other person responsible for care. Some embodiments include the ability to schedule appointments or other blocks of time for a physician's schedule. Some embodiments include artificial intelligence based systems that can provide diagnostic and / or prognostic capabilities and / or the ability to stratify patients based on risk and / or severity.

Description

[0001] MACHINE LEARNING ENABLED MEDICAL MANAGEMENT, INCLUDING SYSTEMS AND USES THEREOF

[0002] CROSS-REFERENCE TO RELATED APPLICATIONS

[0003] This application claims the benefit of U.S. Provisional Patent Application No. 63 / 631 ,820 filed April 9, 2024, which application is incorporated herein by reference in its entirety.

[0004] INTRODUCTION

[0005] Healthcare information and data has the unfortunate combination of being highly organized and also siloed within individual platforms. Because of this siloing of information, an individual (e.g., physician, nurse, patient, caretaker, and / or any other person involved in a patient’s care) must navigate amongst all of these systems to deliver care. With all of these individual sources, generating a comprehensive medical profile for a single individual is difficult, and doing so for an entire medical practice is virtually impossible. The situation is further complicated, as many practitioners are required to comply with various reporting requirements, including preapprovals, justifications, and other ongoing monitoring. Simultaneously, many fields have these additional requirements while also reducing payments or distributions for certain types of medical care. For the foregoing reasons, there is a need for systems and / or devices that can coordinate medical data from various sources and assist in the management.

[0006] SUMMARY

[0007] Systems, methods, and devices for medical practice management. Such embodiments can allow for communication between a practitioner, patient, caretaker, pharmacist, and / or other person responsible for care. Some embodiments include the ability to schedule appointments or other blocks of time for a physician’s schedule. Some embodiments include artificial intelligence based systems that can provide diagnostic and / or prognostic capabilities and / or the ability to stratify patients based on risk and / or severity.

[0008] BRIEF DESCRIPTION OF THE FIGURES

[0009] FIG. 1 provides an exemplary diagram of the interrelatedness of various parties and their responsibilities within a Risk Evaluation and Mitigation Strategy (REMS) program. FIGs. 2A-7 illustrate a walkthrough of an exemplary embodiment for the management of patient care when the patient uses Camzyos™.

[0010] DETAILED DESCRIPTION

[0011] Before the methods, systems, and uses of the present disclosure are described in greater detail, it is to be understood that the methods, systems, and uses are not limited to particular embodiments described, as such may, of course, vary. It is also to be understood that the terminology used herein is for the purpose of describing particular embodiments only, and is not intended to be limiting, since the scope of the methods, systems, and uses will be limited only by the appended claims.

[0012] Where a range of values is provided, it is understood that each intervening value, to the tenth of the unit of the lower limit unless the context clearly dictates otherwise, between the upper and lower limit of that range and any other stated or intervening value in that stated range, is encompassed within the methods, systems, and uses. The upper and lower limits of these smaller ranges may independently be included in the smaller ranges and are also encompassed within the methods, systems, and uses, subject to any specifically excluded limit in the stated range. Where the stated range includes one or both of the limits, ranges excluding either or both of those included limits are also included in the methods, systems, and uses.

[0013] Certain ranges are presented herein with numerical values being preceded by the term “about.” The term “about” is used herein to provide literal support for the exact number that it precedes, as well as a number that is near to or approximately the number that the term precedes. In determining whether a number is near to or approximately a specifically recited number, the near or approximating unrecited number may be a number which, in the context in which it is presented, provides the substantial equivalent of the specifically recited number.

[0014] Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which the methods, systems, and uses belong. Although any methods, systems, and uses similar or equivalent to those described herein can also be used in the practice or testing of the methods, systems, and uses, representative illustrative methods, systems, and uses are now described.

[0015] All publications and patents cited in this specification are herein incorporated by reference as if each individual publication or patent were specifically and individually indicated to be incorporated by reference and are incorporated herein by reference to disclose and describe the materials and / or methods in connection with which the publications are cited. The citation of any publication is for its disclosure prior to the filing date and should not be construed as an admission that the present methods, systems, and uses are not entitled to antedate such publication, as the date of publication provided may be different from the actual publication date which may need to be independently confirmed.

[0016] It is noted that, as used herein and in the appended claims, the singular forms “a”, “an”, and “the” include plural referents unless the context clearly dictates otherwise. It is further noted that the claims may be drafted to exclude any optional element. As such, this statement is intended to serve as antecedent basis for use of such exclusive terminology as “solely,” “only” and the like in connection with the recitation of claim elements, or use of a “negative” limitation.

[0017] It is appreciated that certain features of the methods, systems, and uses, which are, for clarity, described in the context of separate embodiments, may also be provided in combination in a single embodiment. Conversely, various features of the methods, systems, and uses, which are, for brevity, described in the context of a single embodiment, may also be provided separately or in any suitable sub-combination. All combinations of the embodiments are specifically embraced by the present disclosure and are disclosed herein just as if each and every combination was individually and explicitly disclosed, to the extent that such combinations embrace operable processes and / or compositions. In addition, all sub-combinations listed in the embodiments describing such variables are also specifically embraced by the present methods, systems, and uses and are disclosed herein just as if each and every such sub-combination was individually and explicitly disclosed herein.

[0018] As will be apparent to those of skill in the art upon reading this disclosure, each of the individual embodiments described and illustrated herein has discrete components and features which may be readily separated from or combined with the features of any of the other several embodiments without departing from the scope or spirit of the present methods. Any recited method can be carried out in the order of events recited or in any other order that is logically possible.

[0019] PRACTICE MANAGEMENT

[0020] The present disclosure provides for platforms to assist in medical practice management in a more convenient and / or automated fashion. Such platforms can be accessible to a human practitioner and / or one or more patients. In certain instances, the platform is available to multiple practitioners, including practitioners within the same medical facility (e.g., office, hospital, clinic, organization, etc.), medical group (e.g., affiliated or aligned practitioners outside of a single organization), and / or any other relationship between one or more practitioners and one or more patients. In many instances, patients can be enrolled automatically when a practitioner-patient relationship begins, when the patient opts-in to the platform, and / or with any other triggering event. Such enrollment can be an action taken by a medical practitioner (and / or the management of a facility), by action of the patient, or by a combination of actions from both a practitioner and patient (e.g., enrollment by one entity and approval by the other entity).

[0021] Many instances include a scheduling functionality. Scheduling functionality can be used to assist with manual and / or automated scheduling, such that the platform can allow manual entry of an appointment or other time-occupying task (e.g., staff meetings, times for record keeping, times for billing, time to review lab and / or radiology reports, meal and / or snack breaks, etc.). Certain instances may also include automated scheduling functionality — for example, a patient may request an appointment, and the platform can find available blocks of time for such an appointment. Additionally, such automation can further include creating a block of time for review of lab and / or radiology reports when such results are uploaded or sent to the doctor. In certain instances, such scheduling can allow for certain preferences, such as grouping similar tasks (e.g., group report reviewing for multiple patients, setting preferred times of day for new patient appointments, etc.).

[0022] In many instances, a request for an appointment can trigger additional queries or requests for information. Such queries can include listing of symptoms, locations of pain, severity, etc. Such queries can be verified questionnaires, such as for Sino-Nasal Outcome Test (SNOT-20), Eustachian Tube Dysfunction Questionnaire (ETDQ-7), Nasal Obstruction and Septoplasty Effectiveness (NOSE), Short Form 36 (SF-36) Health Survey, Short Form 12 (SF-12) Health Survey, EuroQol-5 Dimension (EQ-5D), Patient Health Questionnaire (PHQ-9), Generalized Anxiety Disorder ? (GAD-7), Hamilton Rating Scale for Depression (HAM-D), Visual Analog Scale (VAS), Brief Pain Inventory (BPI), Pittsburgh Sleep Quality Index (PSQI), Epworth Sleepiness Scale (ESS), Oswestry Disability Index (ODI), Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), Mini-Mental State Examination (MMSE), Montreal Cognitive Assessment (MoCA), Irritable Bowel Syndrome Quality of Life (IBS-QOL), and / or any other relevant survey. For subsequent appointments, the platform can send requests to complete such surveys to track results over time. Based on symptoms or reasoning, the platform can automate requests or orders for radiology and / or testing, such as requesting X-ray, CT scan, ultrasound, MRI, PET, and / or any other type of radiological examination that is relevant to the symptoms. Alternatively or additionally, orders for blood work (e.g., CBC, CMP, lipid panel, etc.) can be ordered. If radiology or testing are ordered, the results may be read by the platform, such as by using a machine learning and / or artificial intelligence model. Such models can be trained to identify physiology and / or ailments (e.g., diseases, disorders, injuries, etc.) based on the results and / or imaging.

[0023] In certain instances, the platform can be used for routine patient follow up, rather than requiring additional in-person appointments or office visits, which can be burdensome for certain individuals. For example, the platform can send messages or inquiries to a patient on a regular basis (e.g., ever month, 3 months, 6 months, etc.) to inquire about symptoms and / or request lab testing. Using the diagnostic and / or prognostic capabilities, the platform can stratify patient risk, such that high risk or severe instances may be prioritized over low-risk or routine appointments. Such capabilities may allow avoidance of a routine appointment and schedule an appointment if / when a physician or patient wants to meet. Depending on situation, such appointments can be scheduled for in person appointments, such as to have additional physical examination or scheduled as a remote appointment, such as for convenience of one or both entities or if no physical contact or examination is warranted based on the results of a routine questionnaires or inquiries.

[0024] Certain instances may also interface with pharmacies and / or pharmacists, if / when prescriptions are ordered by a physician. Such prescribing capabilities can include interfacing with databases for controlled substances (e.g., prescription monitoring programs) and / or databases of drug interactions. Such interfacing can flag worrisome patterns or interactions for a pharmacist and / or medical practitioner. Worrisome patterns can include repeated prescriptions for a controlled substance (e.g., opioids, benzodiazepines, etc.) and / or when a particular drug combination can be harmful or if the combination affects the drug activity of one or more drugs — such as by increasing or decreasing drug efficacy, drug absorbance, drug half-life, and / or any other relevant pharmacokinetic activity. Additional embodiments interface with pharmacogenomic databases, such as if the patient has undergone some level of genetic testing), where a pharmacogenomic database can identify particular drugs or drug categories that may be more effective in treating an individual. In any of the above capabilities (e.g., controlled substance check, drug interaction check, pharmacogenomic check), many embodiments provide alternative drug recommendations or possibilities given such results. For example, if an interaction may increase a drug’s effect, a lower dose can be recommended. As another example, if a monoamine oxidase inhibitor (MAOI) is prescribed, but the pharmacogenomics suggest that a selective serotonin reuptake inhibitor (SSRI) would be more effective, the SSRI can be recommended to the physician.

[0025] On a patient-side of such platforms, the platform may present as an application for a mobile device (i.e., “App”). The app can be used for patient interactions (e.g., surveys, questionnaires, messages, etc.), for virtual appointments (such as by using the microphone, speakers, and cameras of a phone or tablet), and / or for obtaining physiological data from a patient. Such physiological data can be obtained from the phone or tablet directly (e.g., from an accelerometer, LiDAR, camera, etc.) or from a peripheral device connected to the phone, including wearables (e.g., smart watch, pedometer, etc.), smart scales, or other device, such as a continuous glucose monitor, EKG monitor, and / or other device capable of gathering physiological data or information. Such information can be automatically input into the platform or it can be uploaded via action by the patient. Certain instances can automatically input the information, but the information may not be available for others on the platform (e.g., pharmacist, physician) unless or until the patient approves a release of such information.

[0026] As implied herein, many embodiments are capable of sending and / or receiving communications from one or more entities (e.g., practitioner, patient, pharmacist, etc.). Such communication can be audio, video, text-based, etc. Audio communication can use a telephone system (e.g., cellular, landline, etc.) or an internet-based phone system (e.g., VoIP). Text-based communications can include one or more of email, SMS, MMS, fax, and / or any other form of textbased communication. Records of the communications may be kept in a call log or other record of such communications. For audio and / or video communications, some embodiments include transcriptions of the communication.

[0027] As implied above, many embodiments allow accessibility across different platforms and communication types. In some instances, voice calls (e.g., from a non-smart cell phone and / or landline) can allow a platform to walkthrough a survey or other questionnaire to provide as complete of a response and / or communication as possible. Additional embodiments can also include voice-to-text conversion and / or text-to-voice conversion, for asynchronous communication and / or communication with an individual with an audio and / or visual impairment. Additional embodiments include cross-language functionality, such as translation between languages and / or between communication types (e.g., braille). As such, some embodiments are natively in one or more languages and / or include an ability to translate between one or more languages. Languages can include (but are not limited to): English, Spanish, Portuguese, French, German, Danish, Dutch, Mandarin Chinese, Hindi, Arabic, Russian, Bengali, Urdu, Indonesian, Japanese, Swahili, Turkish, Korean, Italian, Tamil, Vietnamese, Greek, Afrikaans, and / or any other language.

[0028] As used herein, the terms “automated” and “automation” refer to aspects that are handled without active human command and / or control. Such processes may be “fully automated,” such that all aspects are handled in response to an event that is independent of human input, while other processes are “semi-automated,” such that a human command precedes one or more actions that are handled automatically. Various instances may incorporate fully automated and semi-automated aspects, such that certain actions occur without human command and other actions occur in response to a human command.

[0029] DIRECTED OR SPECIFIC MANAGEMENT

[0030] Additional embodiments are specific to a particular function or task. For example, certain drugs can have additional requirements prior to and / or during a course of use. Examples of such drugs include drugs that are subject to risk evaluation and mitigation strategy (REMS) programs. Drugs within REMS programs are subject to additional training requirements for a prescribing physician, the patient, and requires ongoing patient monitoring. Certain embodiments are implemented to assist in the training, record keeping, and monitoring. With such embodiments, more patients may benefit from these drugs by reducing the burden on physicians, patients, and / or pharmacists to develop independent systems for regulatory compliance.

[0031] In such embodiments, the systems, methods, and devices herein can be used to provide the requisite training, via audio / visual presentations, quizzes / exams, and / or any other resource. Such training can be provided to one or entities involved (e.g., physician, pharmacist, patient, etc.). As noted above, each entity can be enrolled automatically, manually, or any combination thereof. In certain instances, enrollment in a REMS-specific embodiment (or a REMS module of a larger embodiment), candidacy for enrollment may be flagged to a physician based on medical records (e.g., EHR) associated with the patient.

[0032] In many of these embodiments, the patient is flagged to provide routine input regarding their condition, such as feelings of pain or physical ability or monitorable data, such as glucose levels, blood pressure, weight, pulse, electrocardiogram, and / or other data that can be obtained outside of a clinic using routine or readily available devices (e.g., wearable devices, smart scales, etc.).

[0033] With the routine monitoring or data entry, certain conditions may provide a notice or warning to a patient, physician, and / or pharmacist. Such notifications can include (but are not limited to) reminders to a patient enter information (e.g., daily, weekly, monthly, etc.); notifications to a physician that a patient has not entered in their information; notifications to a physician regarding worrisome changes or trends in patient data; notifications if a patient has not picked up a prescription; recommendations to schedule a follow-up appointment, to schedule a call, to change dose, and / or any other task.

[0034] COMPUTER-READABLE MEDIA AND DEVICES

[0035] Also provided by the present disclosure are computer-readable media and devices. For example, one or more features of any of the methods of the present disclosure may be computer- implemented. “Computer-implemented” refers to at least one step of the method is implemented using one or more processors and one or more non-transitory computer-readable media. The computer-implemented methods of the present disclosure may further comprise one or more steps that are not computer-implemented, e.g., obtaining survey data or other information from a subject, performing one or more “wet lab” steps on the sample (e.g., manual extraction of proteins, lipids and / or metabolites from the sample), and / or the like.

[0036] A variety of processor-based devices may be employed to implement the embodiments of the present disclosure. Such devices may include device architecture wherein the components of the device are in electrical communication with each other using a bus. Device architecture can include a processing unit (CPU or processor), as well as a cache, that are variously coupled to the device bus. The bus couples various device components including device memory, (e.g., read only memory (ROM) and random access memory (RAM), to the processor.

[0037] Device architecture can include a cache of high-speed memory connected directly with, in close proximity to, or integrated as part of the processor. Device architecture can copy data from the memory and / or the storage device to the cache for quick access by the processor. In this way, the cache can provide a performance boost that avoids processor delays while waiting for data. These and other modules can control or be configured to control the processor to perform various actions. Other device memory may be available for use as well. Memory can include multiple different types of memory with different performance characteristics. Processor can include any general purpose processor and a hardware module or software module, such as first, second and third modules stored in the storage device, configured to control the processor as well as a special-purpose processor where software instructions are incorporated into the actual processor design. The processor may essentially be a completely self-contained computing device, containing multiple cores or processors, a bus, memory controller, cache, etc. A multi-core processor may be symmetric or asymmetric.

[0038] To enable user interaction with the computing device architecture, an input device can represent any number of input mechanisms, such as a microphone for speech, a touch-sensitive screen for gesture or graphical input, keyboard, mouse, motion input, speech and so forth. An output device can also be one or more of a number of output mechanisms. In some instances, multimodal devices can enable a user to provide multiple types of input to communicate with the computing device architecture. A communications interface can generally govern and manage the user input and device output. There is no restriction on operating on any particular hardware arrangement and therefore the basic features here may easily be substituted for improved hardware or firmware arrangements as they are developed.

[0039] The storage device is typically a non-volatile memory and can be a hard disk or other types of computer-readable media which can store data that are accessible by a computer, such as magnetic cassettes, flash memory cards, solid state memory devices, digital versatile disks, cartridges, random access memories (RAMs), read only memory (ROM), and hybrids thereof.

[0040] The storage device can include software modules for controlling the processor. Other hardware or software modules are contemplated. The storage device can be connected to the device bus. In one aspect, a hardware module that performs a particular function can include the software component stored in a computer-readable medium in connection with the necessary hardware components, such as the processor, bus, output device, and so forth, to carry out various functions of the disclosed technology.

[0041] Embodiments within the scope of the present disclosure may also include tangible and / or non-transitory computer-readable storage media or devices for carrying or having computerexecutable instructions or data structures stored thereon. Such tangible computer-readable storage devices can be any available device that can be accessed by a general purpose or special purpose computer, including the functional design of any special purpose processor as described above. By way of example, and not limitation, such tangible computer-readable devices can include RAM, ROM, EEPROM, CD-ROM or other optical disk storage, magnetic disk storage or other magnetic storage devices, or any other device which can be used to carry or store desired program code in the form of computer-executable instructions, data structures, or processor chip design. When information or instructions are provided via a network or another communications connection (either hardwired, wireless, or combination thereof) to a computer, the computer properly views the connection as a computer-readable medium. Thus, any such connection is properly termed a computer-readable medium. Combinations of the above should also be included within the scope of the computer-readable storage devices.

[0042] Computer-executable instructions include, for example, instructions and data which cause a general purpose computer, special purpose computer, or special purpose processing device to perform a certain function or group of functions. Computer-executable instructions also include program modules that are executed by computers in stand-alone or network environments. Generally, program modules include routines, programs, components, data structures, objects, and the functions inherent in the design of special-purpose processors, etc. that perform tasks or implement abstract data types. Computer-executable instructions, associated data structures, and program modules represent examples of the program code means for executing steps of the methods disclosed herein. The particular sequence of such executable instructions or associated data structures represents examples of corresponding acts for implementing the functions described in such steps.

[0043] Other embodiments of the disclosure may be practiced in network computing environments with many types of computer device configurations, including personal computers, hand-held devices, multi-processor devices, microprocessor-based or programmable consumer electronics, network PCs, minicomputers, mainframe computers, and the like. Embodiments may also be practiced in distributed computing environments where tasks are performed by local and remote processing devices that are linked (either by hardwired links, wireless links, or by a combination thereof) through a communications network. In a distributed computing environment, program modules may be located in both local and remote memory storage devices.

[0044] In many instances, embodiments may be implemented across a one or more computer networks, where such networks can be local (e.g., within the same facility and / or disconnected from outside computing devices) or networks can be fully dispersed, such that communication occurs across internet architecture (satellites, ethernet, cables, wires, radio waves, etc.). Some networks can use a combination of both local and dispersed networks. In many instances, certain devices communicate directly or via a central server or server farm. Such networking can be static (e.g., all communication follows predefined pathways) or dynamic (e.g., where communications follow pathways based on lag, throughput, and / or another metric of networking or communication performance. In various instances, each device may operate the entirety of an embodiment or multiple devices work in combination to operate the entirety of an embodiment. By way of example, one device may receive physiological data from a patient and provide notifications to a physician or patient. In another example, a first device may communicate physiological data from a patient to a second device, which provides a notification to a third device, such as a notification of a worrisome trend or possible adverse event.

[0045] For purposes of completeness, various aspects of the present disclosure are set out in the following numbered clauses.

[0046] Aspect 1 . A method for managing care for a patient prescribed a risk evaluation and mitigation strategy (REMS) drug, the method comprising: receiving symptomatic data from a patient, wherein the symptomatic data comprises one or more of physiological data and general wellbeing data; providing a notice to the patient if the symptomatic data is not received; providing a notice to a physician if the symptomatic data indicates a possibility of an adverse event.

[0047] Aspect 2. The method of Aspect 1 , wherein the physiological data comprises one or more of: weight, pulse rate, blood pressure, pulse oxygenation data, and electrocardiogram data.

[0048] Aspect 3. The method of Aspect 1 or 2, wherein the general wellbeing data comprises one or more of overall feeling of health and physical ability.

[0049] Aspect 4. The method of any one of Aspect s 1 -3, further comprising transmitting a message from the physician to the patient.

[0050] Aspect 5. The method of any one of Aspect s 1 -4, further comprising transmitting a message from the patient to the physician.

[0051] Aspect 6. The method of Aspect 4 or 5, wherein the message is an audio message, a video message, or a text message.

[0052] Aspect 7. The method of any one of Aspect s 1 -6, further comprising receiving a request for an appointment from the patient.

[0053] Aspect 8. The method of Aspect 7, further comprising transmitting a verified questionnaire to the patient in response to the request for an appointment.

[0054] Aspect 9. The method of Aspect 8, wherein the verified questionnaire is selected from one or more of: Sino-Nasal Outcome Test (SNOT-20), Eustachian Tube Dysfunction Questionnaire (ETDQ-7), Nasal Obstruction and Septoplasty Effectiveness (NOSE), Short Form 36 (SF-36) Health Survey, Short Form 12 (SF-12) Health Survey, EuroQol-5 Dimension (EQ-5D), Patient Health Questionnaire (PHQ-9), Generalized Anxiety Disorder 7 (GAD-7), Hamilton Rating Scale for Depression (HAM-D), Visual Analog Scale (VAS), Brief Pain Inventory (BPI), Pittsburgh Sleep Quality Index (PSQI), Epworth Sleepiness Scale (ESS), Oswestry Disability Index (ODI), Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), Mini-Mental State Examination (MMSE), Montreal Cognitive Assessment (MoCA), Irritable Bowel Syndrome Quality of Life (IBS-QOL).

[0055] Aspect 10. The method of any one of Aspect s 1 -9, further comprising receiving a notice when a prescription is collected from a pharmacy.

[0056] Aspect 1 1 . The method of Aspect 10, further comprising transmitting a notice to the physician if the prescription is not collected.

[0057] Aspect 12. The method of any one of Aspect s 1 -1 1 , further comprising providing educational material to one or more of the physician, the patient, and the pharmacist.

[0058] Aspect 13. A system for coordinating REMS procedures, comprising: a computing device comprising a memory and a processor, wherein the memory comprises instructions that when executed by the processor direct the processor to perform the method of any one of Aspect s 1 -12.

[0059] Aspect 14. A non-transient computer readable medium comprising instructions that when executed by the processor direct the processor to execute the method of any one of Aspect s 1 -12.

[0060] Aspect 15. A method for managing a patient using Camzyos™, the method comprising: enrolling a patient that may benefit from Camzyos™ into a management platform; receiving routine updates of symptomatic data from the patient; notifying a physician when the symptomatic data indicates a possible adverse event and / or need for a change of dose.

[0061] Aspect 16. The method of Aspect 15, further comprising notifying the physician if a prescription is not collected from a pharmacy.

[0062] Aspect 17. The method of Aspect 15 or 16, wherein enrolling a patient comprises: providing educational information to the patient; and obtaining confirmation from the patient that the patient understands the educational information.

[0063] Aspect 18. The method of any one of Aspect s 15-17, wherein the wherein the symptomatic data comprises one or more of physiological data and general wellbeing data.

[0064] Aspect 19. The method of Aspect 18, wherein the physiological data comprises one or more of: weight, pulse rate, blood pressure, pulse oxygenation data, and electrocardiogram data.

[0065] Aspect 20. The method of Aspect 18 or 19, wherein the general wellbeing data comprises one or more of overall feeling of health and physical ability. The following examples are offered by way of illustration and not by way of limitation.

[0066] EXPERIMENTAL

[0067] Example 1 - REMS Management

[0068] The REMS program is a regulatory framework in the United States that is designed to manage the risks associated with certain medications. REMS programs are put in place by the U.S. Food and Drug Administration (FDA) to ensure that the benefits of a specific drug or biological product outweigh its potential risks. REMS programs are implemented to address specific safety concerns associated with certain prescription drugs or biologies. These concerns may include the potential for serious adverse effects, misuse, abuse, or other risks that could outweigh the therapeutic benefits. REMS programs are mandated by the FDA and are a condition of approval for the drug or biologic and are typically required for drugs with a higher level of risk. REMS programs consist of various elements, which can include healthcare provider training, patient counseling, prescribing restrictions, distribution controls, and monitoring and reporting requirements. The specific elements are tailored to the risks associated with the particular drug. REMS programs often require communication between healthcare providers, pharmacists, and patients to ensure that the medication is prescribed, dispensed, and used in a way that minimizes risks.

[0069] One embodiment is designed to assist in the management and compliance with Risk Evaluation and Mitigation Strategy (REMS) programs. Hypertrophic cardiomyopathy (HCM) is the world’s most common genetic heard disease affecting 20 million people worldwide, including 800,000 in the United States. In April 2022, Camzyos™ (mavacamten) was approved for the treatment of adults with symptomatic New York Heart Association class Il-Ill obstructive hypertrophic cardiomyopathy (HCM), which represents approximately 200,000 patients. Camzyos™ is also part of a REMS program requiring prescribing physician training, active patient monitoring, and communication between a prescribing physician, dispersing pharmacy, and the patient. By March 2023, 3,500 doctors (approximately 65% of all cardiologists) have undergone the training to be able to prescribe Camzyos™, but only 1 ,500 people (out of approximately 200,000) have been prescribed the drug. Cited barriers to prescribing include time, effort, and / or difficulty in complying.

[0070] One embodiment is designed to assist in compliance between the relevant parties (prescribing physician, dispensing pharmacist, and patient). Figure 1 illustrates the interrelatedness of these parties and their responsibilities within a REMS program. This example provides a mobile platform with interfaces for each party, including certification, testing, prescribing for the physician; dispensing for a pharmacist; and education and symptom reporting for the patient.

[0071] Figures 2A-7 provide a walkthrough of using this platform for Camzyos™. Figure 2A illustrates an initial screen allowing selection between a physician login 202 and a patient login 204. Walking through the physician aspects first, the next steps including confirming a provider’s identity (Figure 2B), National Provider Identifier (NPI) number (Figure 2C). Figure 2D shows a progression of screens illustrating how the platform can then assist with REMS certification for Camzyos™ with multimedia (e.g., audio and / or video material) and quizzes or queries for the provider.

[0072] Figure 3A illustrates enrollment for a single patient, including name and contact information. Batch or automatic enrollment can also be performed, such as by providing a list of patients or by interfacing with an electronic health records (EHR) system, where entry of the proper diagnosis or diagnostic code triggers automatic enrollment. Figure 3B illustrates a snapshot of enrolled patients 302 with their related tasks 304 and / or status and upcoming appointments for enrolled patients 306. The platform can prompt the physician for any testing requirements before prescription. Ongoing information can be provided or prompted to the physician, such as to schedule a follow up, flag refill approvals, identify missed prescription pickups, or time to contact the patient (e.g., if symptoms indicate a worsening condition). The platform also includes options 308, including to go to a home screen, view more action items or tasks, view patient appointments, and contact patients. Contacting patients leads to a menu (Figure 3C) that allows the provider to filter 310 by prescription, such as when multiple drugs may be monitored; search for a patient 312, and call 314 or message 316 a patient, where messaging can include email and / or text message (e.g., SMS, MMS, etc.).

[0073] Figure 4 illustrates an example of patient registration, which can be de novo or via an invitation link or code sent when a physician enrolls the patient. Figures 5A-5C shows that the platform can further provide patient agreements or educational information, including side effects, warnings, etc. for the patient, followed by certification from the patient that he or she understands the agreement. Figure 6 provides an example of a patient’s home screen, including any upcoming appointments, any optional educational information, and reminders or notifications to provide an update. Figure 7 provides a walkthrough of a daily update, including overall feeling, physical ability, uploading data from an accelerometer (such as a peripheral or wearable device or from inherent devices within a phone), weight, blood pressure, pulse, and upload ECG data (e.g., from a peripheral or wearable device, including Kardia mobile, Apple Watch, etc.). Certain instances can trigger warnings, notices, or communications between a provider and / or patient. One such notice includes worrisome trends in one or more of weight, blood pressure, or pulse that may imply a possible adverse event. In such instances, an urgent notice is sent to the provider to contact the patient. Similarly, if the patient does not provide daily updates for a threshold number of days, a notice can be sent to the provider to contact the patient.

[0074] Accordingly, the preceding merely illustrates the principles of the present disclosure. It will be appreciated that those skilled in the art will be able to devise various arrangements which, although not explicitly described or shown herein, embody the principles of the invention and are included within its spirit and scope. Furthermore, all examples and conditional language recited herein are principally intended to aid the reader in understanding the principles of the invention and the concepts contributed by the inventors to furthering the art, and are to be construed as being without limitation to such specifically recited examples and conditions. Moreover, all statements herein reciting principles, aspects, and embodiments of the invention as well as specific examples thereof, are intended to encompass both structural and functional equivalents thereof. Additionally, it is intended that such equivalents include both currently known equivalents and equivalents developed in the future, i.e., any elements developed that perform the same function, regardless of structure. The scope of the present invention, therefore, is not intended to be limited to the exemplary embodiments shown and described herein.

[0075] TABLE 1 : LIST OF REMS DRUGS

[0076]

[0077]

[0078]

Claims

WHAT IS CLAIMED IS:1 . A method for managing care for a patient prescribed a risk evaluation and mitigation strategy (REMS) drug, the method comprising: receiving symptomatic data from a patient, wherein the symptomatic data comprises one or more of physiological data and general wellbeing data; providing a notice to the patient if the symptomatic data is not received; providing a notice to a physician if the symptomatic data indicates a possibility of an adverse event.

2. The method of claim 1 , wherein the physiological data comprises one or more of: weight, pulse rate, blood pressure, pulse oxygenation data, and electrocardiogram data.

3. The method of claim 1 or 2, wherein the general wellbeing data comprises one or more of overall feeling of health and physical ability.

4. The method of any one of claims 1-3, further comprising transmitting a message from the physician to the patient.

5. The method of any one of claims 1-4, further comprising transmitting a message from the patient to the physician.

6. The method of claim 4 or 5, wherein the message is an audio message, a video message, or a text message.

7. The method of any one of claims 1-6, further comprising receiving a request for an appointment from the patient.

8. The method of claim 7, further comprising transmitting a verified questionnaire to the patient in response to the request for an appointment.

9. The method of claim 8, wherein the verified questionnaire is selected from one or more of: Sino-Nasal Outcome Test (SNOT-20), Eustachian Tube Dysfunction Questionnaire (ETDQ- 7), Nasal Obstruction and Septoplasty Effectiveness (NOSE), Short Form 36 (SF-36) HealthSurvey, Short Form 12 (SF-1 ) Health Survey, EuroQol-5 Dimension (EQ-5D), Patient Health Questionnaire (PHQ-9), Generalized Anxiety Disorder 7 (GAD-7), Hamilton Rating Scale for Depression (HAM-D), Visual Analog Scale (VAS), Brief Pain Inventory (BPI), Pittsburgh Sleep Quality Index (PSQI), Epworth Sleepiness Scale (ESS), Oswestry Disability Index (ODI), Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), Mini-Mental State Examination (MMSE), Montreal Cognitive Assessment (MoCA), Irritable Bowel Syndrome Quality of Life (IBS-QOL).

10. The method of any one of claims 1 -9, further comprising receiving a notice when a prescription is collected from a pharmacy.1 1 . The method of claim 10, further comprising transmitting a notice to the physician if the prescription is not collected.

12. The method of any one of claims 1-11 , further comprising providing educational material to one or more of the physician, the patient, and the pharmacist.

13. A system for coordinating REMS procedures, comprising: a computing device comprising a memory and a processor, wherein the memory comprises instructions that when executed by the processor direct the processor to perform the method of any one of claims 1 -12.

14. A non-transient computer readable medium comprising instructions that when executed by the processor direct the processor to execute the method of any one of claims 1 -12.

15. A method for managing a patient using Camzyos™, the method comprising: enrolling a patient that may benefit from Camzyos™ into a management platform; receiving routine updates of symptomatic data from the patient; notifying a physician when the symptomatic data indicates a possible adverse event and / or need for a change of dose.

16. The method of claim 15, further comprising notifying the physician if a prescription is not collected from a pharmacy.

17. The method of claim 15 or 16, wherein enrolling a patient comprises: providing educational information to the patient; and obtaining confirmation from the patient that the patient understands the educational information.

18. The method of any one of claims 15-17, wherein the wherein the symptomatic data comprises one or more of physiological data and general wellbeing data.

19. The method of claim 18, wherein the physiological data comprises one or more of: weight, pulse rate, blood pressure, pulse oxygenation data, and electrocardiogram data.

20. The method of claim 18 or 19, wherein the general wellbeing data comprises one or more of overall feeling of health and physical ability.

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