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Introducing New Principal Investigator: Dr. Amy Vander Linden

Client News
July 17, 2025
Ready to lead in Women’s Health Shockwave therapy? Discover how you can own your data, access new clinical and financial opportunities, and collaborate with top experts in a supportive community. Join the movement — read more about Dr. Amy Vander Linden’s Circles!
Are you a provider specializing in Women's Health Shockwave therapy? Want to elevate your clinical practice, own your data, and unlock new financial and research opportunities — all while collaborating within a dedicated community? RegenMed is proud to introduce our Women’s Health Shockwave Circles, a high-quality, low-cost, turnkey solution designed specifically for physicians like you. Led by Principle Investigator Amy Vander Linden, this community offers a unique platform to share insights, accelerate innovation, and generate real-world evidence to advance women’s health treatments. Join a network of forward-thinking physicians committed to improving patient outcomes and shaping the future of women’s health interventions. As part of the Circle, you'll gain access to: Proprietary data ownership and controlRobust clinical and financial insightsCollaborative opportunities with leading expertsA supportive community dedicated to advancing women's health Together, we can drive impactful change in Women's Health Shockwave therapy. Elevate your practice, contribute to groundbreaking research, and be part of a movement that puts physicians at the center of innovation. Learn more about Dr. Amy Vander Linden’s Circles below: Female Reproductive System/Clitoral Enhancement/Shockwave/FSFI Pelvis/Pelvic Floor Dysfunction/Shockwave/PUF+ICIQ-UI+BPI Female Reproductive System/Endometriosis/Shockwave/SF-12+FSFI+BPI Female Reproductive System/Polycystic Ovarian Syndrome (PCOS)/Shockwave/SF-12+FSFI+BPI
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Circles Registries For ASCs, IPGs, and IPAs

Post
July 8, 2025
Physician Group Sponsors — now you can easily establish a clinically-impactful and revenue-producing library of proprietary data registries. A Circles Registry Program will materially advance clinical excellence, ethically generate new funding, and add real value to member physicians.
Physician Group Sponsors — now you can easily establish a clinically-impactful and revenue-producing library of proprietary data registries. A Circles Registry Program will materially advance clinical excellence, ethically generate new funding, and add real value to member physicians.What Sets Circles Apart?Clinically Relevant and Peer-Reviewed: Observational Protocols tailored to real-world practice, covering specific anatomical regions, pathologies, and outcomes.Top-Tier Data Quality: Comparable to traditional clinical trials — compliant with HIPAA, GDPR, and more — fully validated, and continuously refreshed with new data.Proprietary & Valuable: No data ownership conflicts — highly licenseable datasets that drive innovation and revenue.Financial & Strategic BenefitsTap into the $60B healthcare data analytics market, growing at 20% annually.License quality datasets to manufacturers, insurers, AI developers, and research centers — 85% of license fees go directly to your physician group.Enhance standards of care, expand service lines, and boost your valuation for future exits.Strengthen negotiating power with payers, improve CMS compliance, and unlock new contracting opportunities.Minimal Effort, Maximum ImpactEasy setup with patented platforms (#inCytes™ & #Benchmarc™).Quick, cost-effective data collection — just $5 per case, $35/month subscription.Engage physicians with minimal burden while fostering collaboration and professional growth.Offer patients personalized feedback, improving engagement and satisfaction.Learn more in our one sheet: "Circles Registries For ASCs, IPGs, and IPAs"
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IRBs And Real-World Evidence Registries

White Paper
June 30, 2025
Discover when physicians can ethically collect real-world clinical data without IRB review. Learn how quality improvement activities differ from research, saving time and resources—all while ensuring compliance.
OverviewWhen physicians collect HIPAA-compliant real-world clinical data during the course of regular medical care to evaluate and improve established treatment protocols — without introducing novel interventions or intending to produce generalizable scientific knowledge — IRB review is not legally or ethically required. This is consistent with both the Common Rule and HIPAA, as well as best practices across academic and clinical institutions.IRB review is not necessary for the HIPAA-compliant collection of real-world clinical data by physicians acting within the scope of their regular practice of medicine, when the primary aim is quality improvement of established treatment protocols.Applicable Definition of “Research”Research v. Quality ImprovementFederal regulations and ethical frameworks governing human subjects research distinguish between activities that qualify as “research” and those that are considered Quality Improvement (QI). Physicians collecting real-world data in the course of standard patient care for the purpose of evaluating or improving existing treatment protocols — without introducing untested interventions, without a plan to contribute to generalizable knowledge, and in compliance with HIPAA — do not meet the regulatory definition of “human subjects research” requiring Institutional Review Board (IRB) review. This conclusion is supported by guidance from the Office for Human Research Protections (OHRP), HHS regulations, and detailed analysis of the Common Rule and HIPAA regulations.Under 45 CFR 46.102(l), "research" is defined as a systematic investigation designed to develop or contribute to generalizable knowledge. If an activity does not meet both components of this definition, it is not considered research and therefore not subject to IRB review.QI activities typically aim to assess or improve internal processes or outcomes and do not intend to generalize findings outside the institution or clinical setting in which they are conducted. The HHS explicitly states that activities conducted to enhance patient care, collect data for administrative purposes, or evaluate provider performance generally do not meet the definition of research and thus do not require IRB review.Even if results are published, QI initiatives do not become “research” unless their design and intent were to develop generalizable knowledge: “The mere intent to publish an account of a QI project does not automatically classify it as research.” (OHRP Guidance.)The HIPAA Privacy Rule (45 CFR 164.501) expressly permits the use and disclosure of Protected Health Information (PHI) without patient authorization when used for health care operations, which include quality assessment and improvement activities, case management, and outcomes evaluation.When physicians collect real-world clinical data solely to improve existing treatment protocols for their own practice, this constitutes a health care operation, not research. If the data are de-identified or handled in accordance with HIPAA’s limited data set provisions, and used within the scope of operations, this does not trigger research regulations.Even if a QI project is borderline, federal guidance offers exemptions under the Common Rule. Category 4 exemption covers secondary research using identifiable private information or biospecimens, when such use is regulated under HIPAA for healthcare operations. No IRB review is needed if the physician is not intervening beyond routine care, not randomizing patients, and is using existing data for internal analysis.What Is Exempt ResearchEven for exempt research formal IRB approval is not required, only a determination that the activity qualifies as exempt. According to the Common Rule, research activities posing no more than “minimal risk” may qualify for expedited or exempt IRB review. Real-world data collected during routine care inherently involves no added risk, as it arises from normal clinical operations.The physician's collection of data without altering standard care, and without interacting with patients for research-specific purposes, reinforces that the activity remains non-research. “QI/QA activities… collecting data solely for clinical, practical, or administrative purposes… do not meet the definition of ‘research’.” — HHS/OHRP.The U.S. Department of Health and Human Services (HHS) and the Office for Human Research Protections (OHRP) provide that QI initiatives do not require IRB review unless they introduce untested clinical interventions intended to produce scientific evidence.The University of Southern California, Boston University, and the Minnesota Department of Health affirm that internal QI efforts carried out as part of normal practice without intent to generalize do not fall under IRB oversight. 1ConclusionCircles represent clinically and financially valuable datasets relevant to licensees for a broad variety of uses. When they are licensed to conduct or support research, it will be the responsibility of the licensee to seek IRB approval when appropriate.In addition, Sponsors are able to establish “Private Circles” where IRB approval may be appropriate. It then is the Sponsor’s responsibility to organize such approvals. RegenMed regularly assists in coordinating with the IRB in such instances. Circles typically involve real-world data collection from multiple sites, making commercial IRBs a practical option when IRB involvement is appropriate. This will also comply with approaches taken by most academic medical centers for multi-site trials. See the SMART IRB Network.
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Monetizing Real-World Evidence For Ambulatory Surgery Centers

Article
June 23, 2025
While the $60 billion healthcare data analytics industry expands rapidly, ASCs are failing to exploit their most valuable asset while others do so. Watch our video that explains how any ASC can generate new revenue streams and asset value by capturing and monetizing real-world evidence (RWE)...
While the $60 billion healthcare data analytics industry expands rapidly, ASCs are failing to exploit their most valuable asset while others do so. This RegenMed video explains how any ASC can generate new revenue streams and asset value by capturing and monetizing real-world evidence (RWE) from routine patient care. Key sections of the video, with time codes, are:The Opportunity [0:18 – 1:14]Real-World Evidence — structured datasets generated from routine patient care — is in high demand across industry and research. The $60 billion healthcare data analytics industry is growing at a rate of over 20% annually. ASCs are not only uniquely positioned to contribute to this market, but to benefit from it financially. RWE licensors include product manufacturers, insurers, research centers, and AI models. Use cases for licenses include competitive intelligence, regulatory submissions, product innovation, legal compliance, value based care, social determinants of health, and health equity. ASCs Can Participate [1:15 – 2:26]ASCs already regularly enter EMR and other real-world data, and pay to do so. However, that data is being aggregated, manipulated, and licensed by others. However, and despite their high cost, RWE datasets synthesizing EMRs, prescription, insurance claim and other disparate sources are incomplete, unverifiable and generally clinically irrelevant. Using RegenMed’s patented Circles technology and processes, ASCs can now structure, aggregate, own and monetize that RWD themselves — without burdening staff or altering clinical workflows. Primary and well correlated datasets which are verifiably sourced from daily patient care – against a prospectively designed Observational Protocol – are far more clinically relevant and “fit-for-purpose” than current RWE offerings. They are therefore far more valuable.What Do Circles Datasets Look Like [2:27–3:40]This section shows two separate illustrative reports. One compares four different knee implant products over twelve months against KOOS Jr. scores in the context of total knee arthroplasty. The second compares two separate surgical techniques over 27 months against a VAS score in the context of total hip arthroplasty.Although these are orthopedics examples, Circles can be and are used to generate clinically and statistically significant datasets for any anatomical region, pathology, treatment protocol, and standardized or custom outcomes score – regardless of medical specialty. EBITDA and New Asset Potential For An Average ASC [3:40 – 6:04]Based on the stated assumptions, which of course will depend on the specific circumstances of each ASC, five Circles datasets generated by ten physicians can produce new annual EBITDA of $850,000 for a total cost of only $31,000 — a return on investment of 14x. Moreover, these five 6-month longitudinal Circles datasets represent asset value of $2.6 million on the stated assumptions. Finally, an ASC can continue to increase these income streams and asset value through continued outcomes capture, additional Observational Protocols relevant to its practice mix, and combining internal and external Circles datasets.ConclusionTo discuss your specific situation, please contact us. RegenMed is not a mere solutions vendor. It works with each Client as a long-term partner to develop meaningful clinical and financial returns on investment.Contact usRegenMed | www.rgnmed.comcircles@rgnmed.com
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