Patent Application Titled “System And Method For Gathering And Analyzing Human Experience Reports” Published Online (USPTO 20200279629)

2020 SEP 17 (NewsRx) -- By a News Reporter-Staff News Editor at Daily Marketing News -- According to news reporting originating from Washington, D.C., by NewsRx journalists, a patent application by the inventors MORRISSEY, Eileen (Mendham, NJ); ANDERSON, Jim (Scottdale, AZ), filed on February 28, 2020, was made available online on September 3, 2020.

The assignee for this patent application is Medicine Differentiation Analytics Llc. (Mendham, New Jersey, United States).

Reporters obtained the following quote from the background information supplied by the inventors: “Developments in the pharmaceutical and healthcare industries, over the past twenty years, have allowed for the creation and subsequent application of a variety of new drugs and related treatments. As new drugs are prescribed and the success of treatment is evaluated, side effects, negative drug interactions, and contra-indications may be observed. Potential negative effects resulting from the use of new drugs can include exacerbation of the treated condition, the creation of complications, and serious concerns including, at the most extreme, death. Negative drug effects may be costly to patients in the aggregate and may not be discovered until after a drug is available on the market.

“Management of treatment contra-indications and negative effects may be time-consuming, difficult, or even impossible, given the variability of success that a given drug may have in treating a condition in a specific patient. Furthermore, the information provided by drug manufacturers may be under-informative, such as content-limited TV and print ads, or over-informative, as may be the case for complex detail labels, which may be dozens of pages long and which may contain technical phraseology which consumers may not comprehend.

“In addition to physicians and patients, governments and insurance companies may be invested in the management of patients’ treatments. The addition of the payors’ interests into the drug-selection calculation adds variables beyond the efficacy and safety of a treatment, factors which may be most relevant to physicians and patients. As governments and insurers may be required to shoulder the burden of patients’ treatments, depending on the specific arrangements, factors including price and duration of treatment, among others, may factor into selection of a treatment method. The factors relevant to a payor’s decision to pay for a treatment may prohibit the selection of certain medications, even after the patient and doctor have selected a course of treatment. These rejections, as well as the potential for possible negative interactions from payors’ suggested substitute treatments, may cause unnecessary delays in treatment and may cause additional drug interactions. These difficulties may be mitigated or avoided by considering drug interactions, treatment preferences, and healthcare formularies at the time that a treatment decision is made.

“As a result of the factors considered by the various interested parties, patients and physicians are often left to optimize treatment by selecting a drug which best suits the needs of the patient and the payor. Factors which may weigh on the drug-selection analysis include, without limitation, whether the drug addresses the patient’s symptoms, whether the drug is included in a patient’s healthcare formulary, i.e., whether a payor will pay for the treatment, whether the method of administration suits the patient’s preference, whether the drug’s side effects conflict with the patient’s prioritized list of undesirable side effects, and whether the treatment will negatively interact with any of the patient’s other drugs, over the counter medications (OTCs), or nutritionals.

“In addition to a solution to the difficulties of selecting an appropriate treatment which serves the needs of patients, physicians, and payors, monitoring of a patient’s response to the treatment may be equally valuable. As patients may consume multiple drugs, OTCs, and nutritionals, the potential for negative interactions may increase. In order to support on-going treatment of a specific patient, and to collect data regarding drug interactions, data from patient reports, physician analyses, and wearable device records may improve the quality of care for a given patient, as well as for those prescribed the same treatments.

“In addition to improving treatment outcomes, the collection of drug interaction data may benefit medication manufacturers by supporting the companies’ regulatory obligations to provide ongoing real-world treatment and evaluation data regarding rates of success in patients and reported negative interactions and effects. To address a lack of post-approval data, particularly concerning drug interactions and ongoing patient monitoring, the Food and Drug Administration has emphasized the need for collection and preservation of Real-World Data (RWD) and Real-World Evidence (RWE). RWD and RWE are useful to the FDA for potential applications in monitoring postmarket safety and adverse events and to make regulatory decisions, to the healthcare community for the development of guidelines and decision support tools for clinical practice, and to medical product developers for application in clinical trial design and in generation of new treatment approaches. Although analysis of RWE may allow for improvements to treatment, diagnosis, and other aspects of medical practice, collection of RWE is stymied by challenges including collaboration barriers, a lack of infrastructure, inconsistent methodologies, privacy concerns, and lack of standardization. The need for effective RWE collection, categorization, and archival solutions remains unmet, despite a growing maket for RWE products and solutions, a market which is expected to grow as large as $1.64 billion by 2024. Due to the large volume of relevant data potentially available, collecting, recording, and correlating the relevant data may be a task too onerous for any one physician or manufacturer.

“The scope challenges presented, regarding selection and monitoring, may be appreciated by consideration of several relevant key figures. Highlighting the value of effective monitoring and selection methods and systems, over one million adverse drug reactions (ADRs) are reported annually, with over 100,000 deaths arising therefrom, ADRs which are estimated to cost the U.S. up to $30 billion annually. Furthermore, between 44,000 and 98,000 deaths may result each year from medical error. The difficulty of addressing these challenges owes largely to the scale of the issue, with more than half of the U.S. regularly taking an average of four prescription medications and older adults often taking more than fifteen, in addition to over-the-counter (OTC) medications, vitamins, and dietary supplements. This issue of scale is further compounded by projected increases in diagnoses, with some estimates projecting that more than 32 million Americans over sixty-five will have two or more chronic diseases by 2030, and by the complexity of diagnosis, treatment, and evaluation. As an example of the complexity of prescription and ADR management, a single multiple sclerosis drug is known to have at least 400 major interactions with other medications, reducing the likelihood of comprehensive evaluation and selection of complementary medications, particularly across many complex disease categories and across millions of patients.

“Further, the question of cost, relevant to both patients and payors, may be addressed by the application of evolving technology. The high cost of treatment derives, in part, from the costs of advertising the treatments to physicians and potential patients. As drug companies may spend large amounts advertising a treatment broadly, taking out print and TV ads in the hope of reaching the subset of patients who would respond favorably to a given medication, the costs of this advertising may be reflected in the costs of the treatment. By selectively targeting certain physicians or patients, medication manufacturers may reduce their costs, a reduction which may be reflected in medication prices. However, targeted advertisement is limited by factors including the broad reach of print and TV ads, the difficulty of selecting relevant potential patients and physicians, and the difficulty of targeting advertisements to those parties who may be interested.

“It would, therefore, be advantageous to provide an efficient and effective evaluation solution for determining the best treatment plan for patients.”

In addition to obtaining background information on this patent application, NewsRx editors also obtained the inventors’ summary information for this patent application: “A summary of several example embodiments of the disclosure follows. This summary is provided for the convenience of the reader to provide a basic understanding of such embodiments and does not wholly define the breadth of the disclosure. This summary is not an extensive overview of all contemplated embodiments and is intended to neither identify key or critical elements of all embodiments nor to delineate the scope of any or all aspects. Its sole purpose is to present some concepts of one or more embodiments in a simplified form as a prelude to the more detailed description that is presented later. For convenience, the term ‘some embodiments’ or ‘certain embodiments’ may be used herein to refer to a single embodiment or multiple embodiments of the disclosure.

“Certain embodiments disclosed herein include a method for gathering and analyzing electronic records. The method comprises the steps of collecting user value statements, determining personal product differentiation (PPD) scores based on the user value statements; collecting experiences related to a user reaction to a product; analyzing the collected experiences based on the PPDs; and generating at least a recommendation of a preferred product for the user.

“Certain embodiments disclosed herein also include a non-transitory computer readable medium having stored thereon instructions for causing a processing circuitry to execute a process. The process comprises the steps of collecting user value statements; determining personal product differentiation (PPD) scores based on the user value statements; collecting experiences related to a user reaction to a product; analyzing the collected experiences based on the PPDs; and generating at least a recommendation of a preferred product for the user.

“Certain embodiments disclosed herein also include a system for for gathering and analyzing electronic records. The system comprises a processing circuitry; and a memory, the memory containing instructions that, when executed by the processing circuitry, configure the system to collect user value statements; determine personal product differentiation (PPD) scores based on the user value statements; collect experiences related to a user reaction to a product; analyze the collected experiences based on the PPDs; and generate at least a recommendation of a preferred product for the user.”

The claims supplied by the inventors are:

“1. A method for gathering and analyzing electronic records comprising: collecting user value statements; determining personal product differentiation (PPD) scores based on the user value statements; collecting experiences related to a user reaction to a product; analyzing the collected experiences based on the PPDs; and generating at least a recommendation of a preferred product for the user.

“2. The method of claim 1, wherein the user value statements includes patient value statements (PVS), and wherein collecting PVS further comprises: collecting a patient’s demographic information; identifying at least one disease area; collecting prioritized symptoms; and collecting prioritized preferences.

“3. The method of claim 2, wherein the collected prioritized preferences include at least one of: routes of administration, unwanted side effects, cost, and lifestyle concerns.

“4. The method of claim 1, wherein determining the personal product differentiation (PPD) scores further comprises: gathering key inputs, wherein key inputs include at least one of: patient medical records, patient healthcare formulary, drug interactions, and product details; and analyzing how each product best meets the PVS while eliminating adverse drug interactions.

“5. The method of claim 1, wherein the collected experiences includes treatment experiences, and wherein collecting treatment experiences further comprises: gathering product monitoring requirements; establishing a tailored monitoring plan; gathering patient treatment experiences based on the tailored monitoring plan; and updating at least one blinded patient experience database.

“6. The method of claim 5, wherein analyzing the collected patient experiences further comprises using artificial intelligence on the collected treatment experiences.

“7. The method of claim 6, wherein using artificial intelligence on the collected treatment experiences further comprises: analyzing features extracted from at least one key database, wherein the least one key database includes any one of: a blinded patient experience database and a blinded patient information database

“8. The method of claim 7, further comprising: using artificial intelligence routines to identify one or more of trends, predictions, learnings, and commonalities.

“9. The method of claim 1, wherein the electronic records are human experience records, and wherein the preferred product is a drug in a specific disease area. 10.

“10. The method of claim 1, further comprising: generating a user interface; and displaying, through the user interface, at least one of: product names, product logos, active ingredients, approval dates, medical history information, administration information, side effect information, and indicator labels.

“11. A non-transitory computer readable medium having stored thereon instructions for causing a processing circuitry to execute a process, the process comprising: collecting user value statements; determining personal product differentiation (PPD) scores based on the user value statements; collecting experiences related to a user reaction to a product; analyzing the collected experiences based on the PPDs; and generating at least a recommendation of a preferred product for the user.

“12. A system for gathering and analyzing human medical treatment experiences, comprising: a processing circuitry; and a memory, the memory containing instructions that, when executed by the processing circuitry, configure the system to: collect user value statements; determine personal product differentiation (PPD) scores based on the user value statements; collect experiences related to a user reaction to a product; analyze the collected experiences based on the PPDs; and generate at least a recommendation of a preferred product for the user.

“13. The system of claim 12, wherein the user value statements includes patient value statements (PVS), and wherein the system is further configured to: collect a patient’s demographic information; identify at least one disease area; collect prioritized symptoms; and collect prioritized preferences.

“14. The system of claim 13, wherein the collected prioritized preferences include at least one of: routes of administration, unwanted side effects, cost, and lifestyle concerns.

“15. The system of claim 13, wherein the system to is further configured to: gather key inputs, wherein key inputs include at least one of: patient medical records, patient healthcare formulary, drug interactions, and product details; and analyze how each product best meets the PVS while eliminating adverse drug interactions.

“16. The system of claim 12, wherein the collected experiences includes treatment experiences, and wherein the system is further configured to: gather product monitoring requirements; establish a tailored monitoring plan; gather patient treatment experiences based on the tailored monitoring plan; and update at least one blinded patient experience database.

“17. The system of claim 16, wherein the system is further configured to use artificial intelligence on the collected treatment experiences.

“18. The method of claim 17, wherein the system is further configured to: analyze features extracted from at least one key database, wherein the least one key database includes any one of: a blinded patient experience database and a blinded patient information database

“19. The system of claim 18, wherein the system is further configured to: use artificial intelligence routines to identify one or more of trends, predictions, learnings, and commonalities.

“20. The system of claim 12, wherein the electronic records are human experience records, and wherein the preferred product is a drug in a specific disease area.

“21. The method of claim 12, wherein the system is further configured to: generate a user interface; and display, through the user interface, at least one of: product names, product logos, active ingredients, approval dates, medical history information, administration information, side effect information, and indicator labels.”

For more information, see this patent application: MORRISSEY, Eileen; ANDERSON, Jim. System And Method For Gathering And Analyzing Human Experience Reports. Filed February 28, 2020 and posted September 3, 2020. Patent URL: http://appft.uspto.gov/netacgi/nph-Parser?Sect1=PTO1&Sect2=HITOFF&d=PG01&p=1&u=%2Fnetahtml%2FPTO%2Fsrchnum.html&r=1&f=G&l=50&s1=%2220200279629%22.PGNR.&OS=DN/20200279629&RS=DN/20200279629

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