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Pre-, peri- and post-operating management of pain for patients suffering from spine indications is a challenging topic for musculoskeletal clinicians. For many years, practitioners were guided towards identifying and treating pain as a major health indicator. In many instances, the resulting opioid crisis has led to the pendulum to swing the other way. While chronic and post-operative pain are real, practitioners struggle to find the right balance between pain management and avoiding the negative side effects of opioid medications. The CDC has stated that “emerging data support clinicians’ carefully weighing the benefits and risks of tapering, or gradually reducing the amount of opioids, along with the benefits and risks of continuing opioids. There is ample literature regarding opioid alternatives – NSAIDS, Transcutaneous electric nerve stimulation, nerve blocks, anti-convulsants and other. However, symptoms, causes and recognition of pain levels are patient specific. The careful physician will consider a variety of approaches, and the level of evidence supporting their safety and efficacy. She will also methodically capture and analyze the real-world data from her own practice, and those of similar clinical settings. We applaud the Northwest Specialty Hospital, and their Principal Investigator Dr. Jessica Jameson, for designing and implementing an IRB-approved study Circle on the controlled use of ketamine in the context of certain spine surgeries. Find out more about this study at clinicaltrials.gov, ID NCT06066879. For more information on this Circle, including applying to join, see here.

TABLE OF CONTENTS‍BACKGROUND THE NATURE AND IMPACT OF CI General Alzheimer’s CLINICAL EVALUATIONS General Standardized Assessments Treatment Protocols Support GroupsCHALLENGES WITH ASSESSMENTS AND TREATMENT PROTOCOLS INTRODUCTION RECOGNITION OF CI TRAINING AND EDUCATION CAREGIVERSUSING CIRCLES TO ADDRESS KEY CI ASSESSMENT AND EDUCATION CHALLENGES INTRODUCTION CI-SPECIFIC CIRCLE USE CASES CI Assessments Integration of All, But Only, Relevant Data Multiple Healthcare Professionals Caregiver Use Experience CI and Real-World Evidence OVERALL CIRCLE BENEFITS Technology Platform and Processes Scalability Further Information On CirclesUSE CASECONCLUSIONFOOTNOTESAbstract‍Cognitive impairment (“CI”) represents major healthcare cost and societal issues. As populations age in developed countries, these issues are receiving increased attention on the clinical, scientific and legislative levels. [1] The first step in any CI treatment is recognition, and then an assessment of its nature and severity. Recognition and assessment are the responsibilities not only of neuropsychiatrists and geriatricians, but of all clinicians. However, conducting standardized clinical evaluations and follow-up measurements presents a number of challenges. These include expertise, staff time, caregiver involvement, integration of lab results and imaging, IT systems, cost, co-morbidities and reimbursement.Circles help address these challenges. A current Circle use case involving the remote delivery of the MoCA assessment [2] is presented at the end of this Article.BackgroundThe Nature and Impact of CIGeneral The prevalence of subjective cognitive decline in the U.S. among adults aged 65 years and older is 12%, and 11% among adults 45-64 years of age. Global healthcare costs in 2019 attributable to cognitive impairment were estimated at $213 billion. Direct social care costs accounted for another $450 billion, and the cost of informal care was estimated to be $650 billion. [3]Moreover, various forms of CI are closely correlated to a number of co-morbidities. [4]In all developed countries with aging populations living longer, these numbers will only increase significantly. [5]Alzheimer’s Cognitive impairment categories include Alzheimer’s, mild cognitive impairment, subjective cognitive decline, vascular cognitive impairment [6], and others. [7]The dominant CI category is of course Alzheimer’s. Statistics from the Alzheimer’s Association [8] include: Between 2000 and 2019, deaths from stroke, heart disease and HIV decreased, whereas reported deaths from AD increased more than 145%.Unpaid dementia caregiving was valued at $340 billion in 2022. Its true costs, however, extend to family caregivers’ increased risk for emotional distress and negative mental and physical health outcomes. Average per-person Medicare payments for services to beneficiaries aged 65 and older with Alzheimer’s or other dementias are almost three times as great as payments for beneficiaries without these conditions, and Medicaid payments are more than 22 times as great. Proper assessment and treatment of CI thus have enormous population health, federal budgetary and societal implications.Clinical EvaluationsGeneral In the U.S., primary care physicians (“PCPs”), surgeons and other healthcare professionals are actively encouraged by their medical societies to look for signs of CI. CMS reimburses CI evaluation as a part of an annual wellness visit. [9] There is extensive literature addressing approaches to CI identification and evaluation. [10] However, PCPs are often hesitant to investigate potential cognitive decline in their patients; many will do so only when family members raise the topic. Moreover, many PCPs perceive limited referral options for patients which may exhibit CI. PCPs often feel they do not possess the expertise necessary to educate their patients about possible treatment options. Standardized Assessments Several CI assessments tools have been developed. These include MoCA [11], IQCODE [12], Mini-COG [13] and QDRS [14]. One can expect many more assessments to be developed. However, most PCPs – and even many specialists – are uncertain as to which is the appropriate assessment tool to use. Moreover, assessment of CI patients often requires caregiver involvement, which may call into question the accuracy of returned scores in the absence of proper controls. Assessment through telehealth poses additional challenges. Treatment Protocols Many individuals are reluctant bring up possible CI symptoms with their healthcare professional. (And, as mentioned, many PCPs and other “frontline” clinicians are reluctant themselves to investigate potential CI.) This is unfortunate since, as with many conditions, early detection allows for a broader variety of treatment options, or at least risk reduction. [15] Currently, three cholinesterase inhibitors are approved for mild to moderate Alzheimer’s [16]. A drug currently approved by the FDA to treat symptoms due to moderate to severe stages of Alzheimer’s is memantine (Namenda®). Other drugs are under investigation, and CI patients are often encouraged to consider clinical trials. Support Groups Besides major groups such as the Alzheimer’s Association and their local chapters, there are many dozens of local CI support organizations. [17] There are also dedicated support groups for caregivers, which of course play a pivotal role in effective CI assessment and treatment. [18] Challenges With Assessments and Treatment ProtocolsIntroductionBy the very nature of CI, assessing and treating it – or at least reducing its associated risks – pose a number of particular challenges. These go well beyond the sheer number of individuals suffering from CI, the necessary involvement of caregivers, and co-morbidities which can result from CI.Recognition of CIIn its early stages, cognitive impairment is often dismissed as forgetfulness or an inevitable part of aging. As mentioned, PCP and other healthcare professionals may be reluctant or insufficiently trained to assess CI, let alone conduct an informed discussion with patients. Although much remains to be learned, it appears that early assessment may make a difference for a patient’s longer-term prognosis. [19] Training and EducationEmergency room HCP’s and primary care physicians are often the first to see a patient with CI. Due to co-morbidities often associated with CI, non-neurological medical specialists such as cardiologists also frequently encounter CI. As mentioned, these “frontline” healthcare professionals may not be trained to assess CI, or properly discuss it with their patients. Indeed, they are often reluctant to do so, and patients are reluctant to bring the topic up. Even for neuropsychiatrists and other CI specialists, relevant medical science and treatment options (e.g., biologics) are often advancing too rapidly to remain current. [20]CaregiversPerhaps more than for any other condition, caregivers play a critical, and nuanced, role in CI assessment and treatment. They are often the first to bring CI symptoms to the attention of a healthcare professional and even the patient him/herself. Initial and ongoing CI assessments typically rely on a caregiver’s support. On the one hand, the caregiver cannot prompt or otherwise influence the patient’s answers. In a telehealth context, it is often the caregiver who needs to log onto a telehealth portal on behalf of the patient, and assist with other technical aspects. Moreover, the caregiver him/herself is generally an important part of a risk reduction or treatment protocol. Finally, the treating clinician needs to be alert to the health of the caregiver as well as of the CI patient. Using Circles To Address Key CI Assessment And Education ChallengesIntroductionA “Circle” integrates the technical platforms and processes allowing any healthcare professional to generate clinical, scientific, and financial value from their everyday cases. Key Circle elements include (i) clinical grade technology, (ii) minimal burden for the provider and patient, (iii) inherent collaboration within and across institutional and national boundaries, (iv) publication/influence, and (v) cost-effectiveness. Circles are ideal for clinicians, whatever their specialty, in assessing, monitoring, and treating cognitive-impairment patients. Further information is provided at the end of this article. CI-Specific Circle Use CasesCI Assessments The observational protocol component of a Circle typically contains separate sections for pre-clinical, clinical, and long-term outcomes assessments. The nature of data to be collected in each section is determined by the clinician, often in conjunction with peers or a clinical/scientific expert. In the field of cognitive impairment, Circles can incorporate any standardized assessment tools, such as MoCA, IQCODE, Mini-COG and/or QDRS. Alternatively, the clinician can modify these, or develop his/her own assessment scoring. If desired by the clinician, RegenMed handles the remote delivery of the assessment. [21]Integration of All, But Only, Relevant Data CI assessment, risk reduction and/or treatment data may include lab results, imaging, self-reported evaluations, broader health metrics (sleep, exercise, etc.), information on status of co-morbidities, and of course original clinical data. EMRs may capture some but not all of this information. Moreover, they will capture a good deal of information which is irrelevant. Each Circle is designed for a specific indication, treatment protocol, and outcomes assessment scoring. The clinician and his fellow Circle Members can thus easily capture, aggregate, verify and analyze all of the necessary data, without unnecessary or confusing artifacts. Multiple Healthcare Professionals CI patients often see more than one specialist, in addition to their primary care physicians. Each clinical encounter yields information potentially relevant to CI assessment and treatment protocol design or adjustment. However, those providers frequently do not have the time meaningfully to communicate with each other. Also, they may be utilizing different EMR systems. More critically, those systems are not set up to collect the data most relevant to cognitive impairment decisions. Circles inherently support collaboration among all providers involved in the care of a CI patient. Caregiver Use Experience Caregivers can have their own Benchmarc™ [22] accounts to track a patient’s reports and progress. Digital consents forms also allow patient approval of caregiver PHI access. The clinician can also include a separate caregivers survey in the observational protocol, to further strengthen the involvement of the caregiver in the patient’s risk reduction or treatment plan. CI and Real-World Evidence Approaches to cognitive impairment assessments, risk-prevention and treatments are fast evolving. Real-world evidence is an essential part of the developing medical science, as well as its clinical translation. Regulators, legislative bodies, and payers recognize the potential of real-world evidence to improve healthcare outcomes and reduce costs. [23] This has led to a proliferation of registries [24] and study designs – pragmatic, quality improvement, observational, and other. [25] A corollary is the requirement for more inclusiveness and diversity in clinical trial design. [26] Circles thus develop and extend clinically significant standards of cognitive impairment care. [27] Importantly, they can be utilized by large academic medical centers, as well as smaller practicing dealing with CI patient populations. Overall Circle BenefitsTechnology Platform and Processes Circles utilize the clinical grade [28] and patented [29] clinician-facing inCytes™ and patient-facing Benchmarc™ platforms. They include patient and caregiver enrollment, long-term outcomes capture, report generation, publication, single and multi-center administration, publication, industry funding, IRB support and other integrated capabilities. The Circles user experience emphasizes patient engagement, comprehension of medical conditions and proposed treatment paths, and long-term compliance. Scalability Circles support the identification, onboarding, and active involvement of providers within and outside of institutional and regional boundaries. Their inherent flexibility accommodates efficient data collection from the small patient panel of small practices, as well as patient populations of virtually any size. Further Information On Circles‍Circle Overview ‍Circles/What Is A Circle ‍KnowledgeBase ‍LinkedIn Corporate Page ‍Latest ‍Contact Us Use CaseA leading U.S. neurologist has designed and implemented a Circle focusing on patients suffering with moderate cognitive impairment. He is utilizing the MoCA assessment tool, which is administered through RegenMed by MoCA certified personnel quarterly for at least one year. Lab results and other clinical information will be included in each patient record. In addition, the Circle Founder will be enlisting other neurologists and CI specialists from around the world as Circle Members (essentially co-investigators). The Circle Founder will regularly report to all Circle Members on protocol design elements, as well as statistically significant correlations arising from the aggregated Circle datasets.ConclusionCognitive impairment, in all of its manifestations, is one of this century’s most pressing healthcare, economic and societal issues. Evidence-based approaches to CI assessment, risk reduction and treatment are sorely needed. These goals are complicated by the very nature of CI, the frequent presence of co-morbidities, the relatively undeveloped nature of CI science, and the importance of caregivers as extensions of healthcare providers. Circles are already helping clinicians in their efforts to address these challenges efficiently.Footnotes1 See https://aspe.hhs.gov/reports/risk-costs-severe-cognitive-impairment-older-ages-key-findings-our-literature-review-projection-0, https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10357114/, https://www.thelancet.com/journals/lanepe/article/PIIS2666-7762(22)00168-5/fulltext2 https://www.verywellhealth.com/alzheimers-and-montreal-cognitive-assessment-moca-986173 https://alz-journals.onlinelibrary.wiley.com/doi/full/10.1002/alz.12901. See also https://www.ahajournals.org/doi/epub/10.1161/01.STR.0000017878.85274.44, https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5657516/4 https://www.cdc.gov/aging/publications/chronic-diseases-brief.html5 https://www.cdc.gov/aging/data/subjective-cognitive-decline-brief.html6 https://www.heartandstroke.ca/stroke/what-is-stroke/vascular-cognitive-impairment7 See this list from onemajor academic medical hospital system https://www.mountsinai.org/care/neurology/services/cognitive-disorders8 https://pubmed.ncbi.nlm.nih.gov/36918389/9 https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNProducts/preventive-services/medicare-wellness-visits.html10 See for example https://www.nia.nih.gov/health/assessing-cognitive-impairment-older-patients, https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4119094/, https://www.uspreventiveservicestaskforce.org/uspstf/recommendation/cognitive-impairment-in-older-adults-screening, https://www.facs.org/for-medical-professionals/news-publications/news-and-articles/bulletin/2023/september-2023-volume-108-issue-9/cognitive-screening-in-older-patients-may-help-optimize-outcomes/11 https://mocacognition.com/12 https://www.alz.org/media/documents/short-form-informant-questionnaire-decline.pdf13 https://mini-cog.com/14 https://www.guidetolongtermcare.com/images/The-Quick-Dementia-Rating-System.pdf15 See for example https://my.clevelandclinic.org/health/diseases/17990-mild-cognitive-impairment16 Galantamine (Razadyne®), Rivastigmine (Exelon®) and Donepezil (Aricept®). Lecanemab (Leqembi®), and aducanumab (Aduhelm®) have also been approved by the FDA for the treatment of early Alzheimer's disease. 17 https://www.alzheimersla.org/, https://www.caregiver.org/resource/mild-cognitive-impairment-mci/, https://www.alz.org/cacentralcoast/helping_you/support-groups18 https://alzfdn.org/caregiving-resources/alzheimers-and-dementia-support-groups/19 https://www.alz.org/alzheimers-dementia/what-is-dementia/related_conditions/mild-cognitive-impairment20 https://www.nia.nih.gov/about/advances-alzheimers-disease-related-dementias-research21 For example, RegenMed handles MoCAbenchmark and post-clinical assessments for some Circle founders.22 https://kb.rgnmed.com/what-is-benchmarc23 See for example FDA, Real World Evidence, FDA, Post-Market Surveillance Programs; The 21st Century Cures Act; NIH Grants Program For Real-World Studies; Expect To See More RWE-Based Regulatory Decisions, Robert Califf, FDA Commissioner; Use Of Real-World Evidence In Regulatory DecisionMaking, European Medicines Agency.24 See Registries for Evaluating Patient Outcomes: A User's Guide: 4th Edition, Agency for Healthcare andQuality and Research, U.S. Department of Health and Human Services.25 See Pragmatic Trials, NEJM, Ford and Norrie, Quality Improvement Projects and Clinical Research Studies, Faiman, and Quality Improvement In Practice, Backman.26 See for example, Diversity and Inclusion InClinical Trials, NIH; Why Diverse Clinical Trial Participation Matters, Schwartz et al, New England Journal Of Medicine.27 See Transforming Medicare Coverage: A New Medicare Coverage Pathway for Emerging Technologies and Revamped Evidence Development Framework, Fleischer et al., Center For Medicare and Medicaid Services; Center For Clinical and Translational Science/Product Development Pathways, Mayo Clinic. What Is The Evidence For Our Standards Of Care?, Turka et al, The Journal Of Clinical Investigation.28 HIPAA, GDPR, Part 11, FHIR HL7 Compliant. Scalable. All data and edits fully auditable. Multilingual. Real-time 24/7 accessibility by patients and clinicians from any device in any location. Robust role, permission, clinician branding, and other customization settings.29 U.S.patent number 11720567, Method and System For Processing Large Amounts Of Real-World Evidence.Copyright © 2023 Regenerative Medicine LLC

The concept of value-based care (“VBC”) is that incentives (and disincentives) imposed on providers will lead to less expensive and higher quality healthcare.A large amount of data has been collected regarding the performance of various VBC models. Some have been modestly successful; others not at all. Value-based care broadly defined is here to stay. It is both laudable and achievable. However, its objectives are undermined by imposing on providers complex, burdensome, varying, and expensive “incentives”, often misaligned with the realities of everyday clinical practice.There are many challenges to achieving the twin promises of lower costs and better healthcare metrics for broad patient groups. Changing well established norms and expectations is unlikely to occur on the basis of laws and regulations alone. Indeed, in many ways, federal attempts to solve multiple challenges at once on a national scale have proved self-defeating.Conversely, the smaller, more focused, VBC efforts seem to have shown greater success. Also, trusting the inherent desire of providers to deliver proper care to their patients at a transparent and reasonable price is more likely to achieve the promise of value-based care.The tools and processes needed to drive meaningful and positive VBC results need not be expensive or burdensome. Circles have demonstrated this. They integrate the technology, processes, user experience, and low cost which make support value-based care for practitioners around the world.For more information on this topic, see this article. For more information on Circles, please

RegenMed is proud to announce that Dr. Claude T. Moorman has joined the company’s Clinical/Scientific Advisory Board. Dr. Moorman is the Chair of the Department of Orthopaedic Surgery, and presides over the Musculoskeletal Institute, at Atrium Health. He has authored more than 150 publications, and his research has been recognized with numerous honors, including the Neer Award and the Excellence in Research Award for innovations in shoulder reconstruction.Atrium is a major part of Advocate Health, the fifth-largest nonprofit integrated health system in the United States. Wake Forest University School of Medicine is its academic core. Advocate Health serves 6 million patients and is engaged in hundreds of clinical trials and research studies. It is nationally recognized for its expertise in cardiology, neurosciences, oncology, pediatrics, and rehabilitation, as well as organ transplants, burn treatments and specialized musculoskeletal programs. Dr. Moorman joins Doctors Ken Zaslav and Bert Mandelbaum, also internationally recognized orthopedic surgeons affiliated with major academic medical institutions, on RegenMed’s C/SAB. They provide strategic advice as RegenMed, through Circles, supports musculoskeletal practitioners globally in generating clinical, scientific, and financial value from real-world evidence. The Company’s C/SAB will continue to expand as RegenMed works with leading providers in other medical fields. For example, Circles are already being used in the fields of endocrinology, cognitive impairment assessments, and interventional pain management. For more information, please

TABLE OF CONTENTS‍THE MARKET NEED Clinical Trials and Other Studies Value-Based Care Inequality In Healthcare Delivery Cost and Complexity Physician and Patient Engagement Faster Product and Protocol Development Data Control and Ownership Too Much DataCIRCLES Technical Platform Processes User Experience Inherent Collaboration Support KOL and Investigator Recruitment Partnership and Return On InvestmentSELECT USE CASES Clinical Decision Making Trials and Studies Education and Training Registries Commercial/Financial Publication Legal/Regulatory ComplianceFOR FURTHER INFORMATIONFOOTNOTESAbstractReal-world evidence is at the heart of value-based care and informed clinical decision-making. It supports better, lower-cost healthcare for all population groups. It is increasingly required for regulatory approvals.RWE derives from real-world data. RWD derives from everyday patient-clinician interactions, tied to long term outcomes capture.Circles capture RWD and develop RWE in a minimally burdensome and cost-efficient manner. Equally important, they generate clinical, scientific, and financial value for all Circle Members.The Market NeedThe efficient collection and aggregation of real-world data – and the generation therefrom of clinically-significant real-world evidence – can make a material difference in helping solve many of modern healthcare’s most pressing challenges.Clinical Trials and Other Studies Regulators, legislative bodies and payers recognize the potential of real-world evidence to improve healthcare outcomes and reduce costs. [1] This has led to a proliferation of registries [2] and study designs – pragmatic, quality improvement, observational, and other [3]. A corollary is the requirement for more inclusiveness and diversity in clinical trial design. [4] Value-Based CareThe trend towards value-based care is inexorable. [5] For many years, government and private insurers have adopted explicit or implicit reimbursement schema moving away from fee-for-service.As their share of healthcare costs continues to rise, patients are selecting providers and treatments on the basis of perceived value.Self-funded employer groups [6] and other forms of narrow networks are increasing, driven by the concept of value-based care.Inequality In Healthcare Delivery The U.S. spends far more per capita on healthcare than other countries, with worse outcomes in most categories. [7] Within the U.S., and many other countries, the accessibility and quality of healthcare services vary substantially by region and economic class. [8]Cost and ComplexityTo a large extent, the challenges identified above derive from high (and often opaque) costs and unnecessary complexity at all levels of the healthcare delivery system.Physician and Patient EngagementEven post-pandemic, healthcare professionals are demoralized, and leaving the industry altogether. [9]There has been a steady decline of trust in healthcare leaders and the medical system. This erosion of trust is shared by many healthcare professionals. [10]Faster Product and Protocol DevelopmentThe national legislation and regulatory developments illustrated in footnote 1 are the result of broad demand for faster, less expensive pathways to market for medical products, as well as more evidence-based standards of care. [11]Data Control and OwnershipAs “big data” and other forms of anonymized healthcare datasets become prevalent, ownership by data sources and use by others of such datasets often remains poorly undefined.Too Much Data“Big data” and faster algorithms have disappointed many by failing to provide usable clinical evidence. [12] This is generally due weak data verifiability, lack of clinical context, and limited long-term outcomes data demonstrably linked to specific clinical interventions.‍CirclesCircles integrate clinical grade healthcare data platforms with processes focused on clinician- and patient-engagement. Each Circle addresses a specific real-world evidence objective, and is designed to generate a demonstrable return on investment in the form of clinical, scientific and/or financial value.‍Technical PlatformCircles utilize the patented clinician-facing inCytes™ and patient-facing Benchmarc™ platforms. [13] This technology is competitive with much more expensive, and less user- friendly, EHR, CRO, PROM and similar data software. [14]ProcessesRegenMed can handle patient enrollment, long-term outcomes capture, report generation, publication, ongoing collaboration support, publication, industry funding, IRB support and similar administrative elements.User ExperienceMinimizing administrative burden for clinicians and their staff is an essential feature of all Circles.Circles emphasize patient engagement, comprehension of medical conditions and proposed treatment paths, and long-term compliance.Inherent Collaboration SupportCircle Members collaborate within and across institutional and national borders. Circle Hours [15], Circle Academies, and other RegenMed processes sustain that collaboration.KOL and Investigator RecruitmentJoin-A-Circle and associated RegenMed processes support the identification, onboarding and active involvement of clinical/scientific experts, as well as additional Circle Members.Partnership and Return On InvestmentRegenMed works with each client to determine its Circle objectives – clinical, scientific and/or commercial. These are translated into key performance metrics, which in turn are the basis for demonstrable ROI ethics committees.‍Select Use CasesCircles are used by large provider groups, sole practitioners, medical societies, product manufacturers, veterinarians, researchers and other healthcare constituencies around the world. Illustrative client approaches to the efficient generation of clinical, scientific and financial value are summarized below.Clinical Decision MakingCapture long-term outcomes.Develop, improve, confirm standards of care.Coordinate care pathway across multiple healthcare professionals. [16]Remote patient therapies and monitoring. Monitoring and treatment of chronic conditions.Incorporate evidence-based medical science into treatment protocols, including through integration of lab results. Trials and StudiesFormal clinical trials. Including engagement with IRBs and medical ethics committees.Real-world study formats, including private, pragmatic, N of 1, observational, quality control, prospective, retrospective, research.INDs, IDEs, PMAs, post-market surveillance, other regulatory submissions. Single or multi-center. Any size or complexity. Education and TrainingResidents, fellowship, and other department programs.Augment CME courses. Mortality and morbidity conferences. Medical practice website and patient literature. RegistriesFor medical societies, foundations, narrow networks, payers, hospital departments, product manufacturers, ASCs. Commercial/FinancialProduct improvement and development. New service lines and indications. Reimbursement.Reduction of administrative, IT, research, regulatory submission, and marketing costs.Payer negotiations/ratings.KOL recruitment, influence expansion. Honoraria, Investigator fees, product discounts, travel purses. Data licensing. Professional advancement. PublicationJournals.Conference presentations and posters.HCP and patient communications.Newsletters.Department abstracts.Grant proposals.Legal/Regulatory Compliance Support novel, compassionate use, right-to-try, experimental and similar treatment protocols.Confirm adverse event tracking.Expert medical opinions and other forensic uses.‍For Further InformationRgnMed.com/Circles/GeneralJoin/Start A CircleKnowledgeBase LinkedIn Latest Contact UsFootnotes1 See for example FDA, Real World Evidence, FDA, Post-Market Surveillance Programs; The 21st Century Cures Act; NIH Grants Program For Real-World Studies; Expect To See More RWE-Based Regulatory Decisions, Robert Califf, FDA Commissioner; Use Of Real-World Evidence In Regulatory Decision Making, European Medicines Agency.2 See Registries for Evaluating Patient Outcomes: A User's Guide: 4th Edition, Agency for Healthcare and Quality and Research, U.S. Department of Health and Human Services.3 See Pragmatic Trials, NEJM, Ford and Norrie, Quality Improvement Projects and Clinical Research Studies, Faiman, and Quality Improvement In Practice, Backman.4 See for example, Diversity and Inclusion In Clinical Trials, NIH; Why Diverse Clinical Trial Participation Matters, Schwartz et al, New England Journal Of Medicine.5 See for example Value-Based Health Care at an Inflection Point: A Global Agenda for the Next Decade, Larsson et al, New England Journal Of Medicine; Value-Based Care: What It Is and Why It’s Needed, The Commonwealth Fund; Value-Based Programs, U.S. Center For Medicare and Medicaid Services; Understanding The Value-Based Insurance Design, U.S. Department of Health and Human Services, National Center For Chronic Disease Prevention and Health Promotion.6 The 2020 Kaiser Family Foundation Survey of Employer Health Benefits reports that 67 percent of employed, insured workers are covered under self-insured, or self-funded, arrangements. See also, example, Health Transformation Alliance and Self-Insurance Institute Of America.7 See How Does The U.S. Healthcare System Compare To Other Countries?, Peter G Peterson Foundation.8 See Healthcare Access In Rural Communities, Rural Health Information Hub; Serving Vulnerable and Underserved Populations, U.S. Department of Health and Human Services.9 See Physician Suicide, Matheson, American College of Emergency Physicians; Strengthening The Healthcare Workforce, American Hospital Association.10 See Trust In Medicine, The Health System and Public Health, MIT Press; Surveys Of Trust In The Health Care System, University of Chicago.11 See Transforming Medicare Coverage: A New Medicare Coverage Pathway for Emerging Technologies and Revamped Evidence Development Framework, Fleischer et al., Center For Medicare and Medicaid Services; Center For Clinical and Translational Science/Product Development Pathways, Mayo Clinic. What Is The Evidence For Our Standards Of Care?, Turka et al, The Journal Of Clinical Investigation.12 See Medical Innovation and Digital Snake Oil, American Medical Association; Why Does Big Tech Often Fail In Healthcare?, Healthcare Information and Management Systems Society.13 U.S. patent number 11720567, Method and System For Processing Large Amounts Of Real-World Evidence.14 HIPAA, GDPR, Part 11, FHIR HL7 Compliant. Scalable. All data and edits fully auditable. Multilingual. Real-time 24/7 accessibility by patients and clinicians from any device in any location. Robust role, permission, clinician branding, and other customization settings.15 Regular livestream and recorded sessions among Circle Members reviewing observations, best practices, study variations and emerging correlations.16 For example, surgery and rehabilitation, referring and treating physicians in context of “medical tourism”, radiation oncology and wound care/plastic surgery.‍Copyright © 2023 Regenerative Medicine LLC‍