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INTRODUCTIONHealthcare data is all the rage. Big data, artificial intelligence, value-based care, metadata, real-world data, clinical trials, registries, genomic data — they are all part of a market with an estimated value in 2028 of $130 billion. But who really owns this data? Who controls it? Who benefits from it, and who is left out?Ownership is often not the same as control. Neither does it guarantee value. Clarifying one’s objectives in the context of healthcare data, generating inherently valuable datasets, and specifying one’s rights with other stakeholders are all important steps for any clinician in today’s modern healthcare world.OWNERSHIPIn the healthcare sector, data ownership is generally governed by national laws and institutional policies. Typically, but not always, these relate to personal data and protected health information. HIPAA in the U.S. and GDPR in the European Union are important examples. GDPR’s provisions are widely recognized as the strictest regarding personal data and special categories thereof, including personal health information (сollectively referred to as Personal Data in this article).The spirit and letter underlying Personal Data laws are patient ownership of such data. Patients may consent to share or otherwise convey some of their ownership rights, but that consent must be highly explicit. Civil and criminal penalties for wrongfully and even accidentally appropriating personal data are severe.Healthcare data which has been suitably anonymized or pseudonymized is not considered Personal Data. The laws governing adequate anonymization or pseudonymization are complex and highly fact specific. They involve aggregation, security, encryption, consent form, control, data-processing and other elements, looked at as a whole. Failure to comply with any of these elements can render non-Personal Data into Personal Data, with resultant liability.Some organizations, including RegenMed, refer to properly anonymized or pseudonymized Personal Data as Aggregated Non-Personal Data. Such data may be owned wholly or in part by entities or individuals other than the individuals from whom such data originally derived. However, absent clear contractual specification of Aggregated Non-Personal Data ownership rights, disputes can arise, especially once it is clear that such data can generate value.CONTROLIn the healthcare world, it is not unusual for control of data — whether Personal Data or Aggregated Non-Personal Data — to be separate from ownership. The GDPR, for example, has detailed provisions covering data controllers, data processors, sub-processors, joint controllers and similar designations covering control of data which may be wholly or partially owned by others.Similarly, physician employment agreements, hospital data policies, registry participation, grant terms and conditions, clinical trial consent forms and many other arrangements restrict and grant various degrees of control over healthcare data. Such transfers of control can of course substantially vitiate the value otherwise obtainable from ownership of Aggregated Non-Personal Data.Control over Aggregated Non-Personal Data thus takes many forms and has many serious implications — not all of them initially evident. Physicians and other healthcare providers (HCPs) frequently sign away any control over or interest in discoveries, inventions and datasets deriving from their everyday clinical practices. Healthcare professionals and their patients are the principal contributors to registries and other aggregated healthcare datasets, but often transfer substantial control over the use and value of such contributions. Clinical trial, journal article and medical research data are often maintained in secrecy for many years, and even then, released only partially.GENERATING VALUEAs mentioned, healthcare data generates well over $100 billion in value each. Major areas of value generation include product development, regulatory compliance, marketing, government- and foundation-funded research, payer reimbursement, value-based care and the large infrastructure of vendors servicing such segments. Thus, most monetary value generated through healthcare data accrues to medical product manufacturers and distributors, payers, hospital systems, EMR companies and various data vendors.Very little of that monetary value flows to the healthcare professionals. This is paradoxical since the most important — and therefore the most valuable — healthcare data emanates directly from the everyday clinician-patient interaction.This inability of HCPs to develop value from healthcare data can be attributed to several factors, including everyday clinical burdens, challenges in collaborating in data aggregation with peers, inadequate tools and processes, expense and limited business/legal expertise.CONCLUSIONAs mentioned, the most potentially valuable healthcare datasets are those which are based on the clinician-patient interaction. To achieve that value, those datasets must include long-term follow-up tied to specific clinical hypotheses. The datasets should also be verifiable, integrated and statistically significant in the context of those hypotheses.Circles, powered by inCytes™, support HCPs around the world in developing and generating value from such datasets. Circles can be implemented to address any clinical or medical-scientific question and are supported by an enterprise-grade yet low-priced SaaS platform equipped with international collaboration with like-minded peers and experts.

In these final days of 2021, RegenMed pays tribute to the world’s healthcare professionals. We see first-hand the burdens, stresses and challenges of everyday clinical life — all of course exacerbated by COVID-19. In the U.S., a full one-third of clinicians now report burnout. For many, this stems from an increasing sense of isolation — from peers, patients, mentors and even purpose. These are alarming trends for the future of healthcare.We all do our best work, and feel most fulfilled, by interacting with colleagues, and collaborating in a deep and sustained manner. It has been our privilege this past year to support such deep collaboration among clinicians in Europe, North America, South America and Asia. Their evidence-based Circles are fostering new relationships, and helping to advance tomorrow’s clinical standards across a multitude of specialties and topics of interest.Meet some of our Circle Founders from around the world.To learn more about any of the above Circles or explore how a Circle can advance your evidence-based initiative, contact us today.

Regenerative medicine and precision cancer care may be the future of healthcare for humans, but it is yesterday’s news for forward-thinking company Ardent Animal Health, LLC. Ardent and its affiliated veterinary clinics have treated more than 20,000 horses, dogs and cats with their innovative regenerative and oncology armamentarium. These therapies have shown promising results with degenerative joint and oncological indications — even in instances where traditional therapies have failed — creating a growing list of “petsimonials”.Working with RegenMed, Ardent plans on launching a leading clinical data registry in early 2022 to aggregate and assess those animal outcomes. Bolstered by participation from more than 1,000 affiliated clinics, Ardent anticipates that their data will play a pivotal role in helping to standardize regenerative treatments and precision cancer care for animals, and perhaps one day, their owners, too.Thomas Masterson, President of Ardent Animal Health, states, “Aggregating data and sharing patient outcomes is integral to the sustainability of innovative technology. Our veterinarian customers are outstanding clinicians and scientists. RegenMed will unlock collaboration and allow for a registry that is aimed to raise the standard of care for veterinary patients.”Ardent Animal Health will launch its first two Circles for Osteoarthritis and Oncology in early 2022.To learn more about Ardent Animal Health or its Circle, contact us today.

Lower back pain is among the top 10 reasons for occupational absenteeism, placing a strong economic incentive for preventing and treating this prolific symptom. Opiate use has been a traditional standard of care, but its failure to address the underlying cause of disease coupled with a global rise of addiction, has caused payers to look for alternative solutions.First State Spine offers patients orthobiologic spine treatments, including platelet rich plasma “PRP” and bone marrow derived stem cells. These novel procedures are currently out of pocket, but First State Spine is using their Circle to monitor patients’ post-operative outcomes over time, including reduction in pain, opiate usage, and return to work. Bonnie O’Connor, PA-C, who oversees the evidence-based initiative, has tried other patient follow-up systems, but says this about Circles:"Circles has allowed our facility to customize surveys in addition to incorporating the standard outcome measures for Orthobiologic patients. The process is streamlined for staff, patients and reporting. Customer service has been responsive and helpful from start to finish.”First State Spine intends to use their Circle data to generate real-world evidence demonstrating long-term treatment and cost-efficacy, helping future patients to receive reimbursement.To learn more about First State Spine or its Circle, contact us today.

This recently published position statement by the AMSSM summarily articulates the opportunities, risks and considerations for inclusion of orthobiologics into a modern sports medicine practice.What leaps out at us, having been privy to the slow, at times chaotic, but seemingly inevitable global adoption of these therapies for more than seven years, is the growing inequity between hundreds of thousands of patients treated and the continued debates upon, or outright absence of, strong, definitive clinical data. This isn’t to say that these therapies don’t work, but rather, that the world is much more advanced at delivering this sort of care than understanding it.This no longer needs to be the case. The rising role and acceptance of real-world evidence, the increased availability of clinically efficient data capture technologies and the growing interconnectivity and collaboration of globally disparate, but singularly minded, “good actor” practitioners, hold the combined weight to convert growing patient volumes into evidence-based standards of care. Such evidence-based practitioners will help advance the field, but on a more practical, personal level, they will find collecting and contributing such evidence useful for a good number of AMSSM’s expert recommendations, including:Patient Education Patient Selection Regulatory Documentation and Submissions Clinical Decision-MakingProduct Quality Control Informed Patient Consent Professional Collaboration and Training Publications and Presentations RegenMed hopes that this continued leadership among good clinical actors, paired with growing volumes of integrated, longitudinal and statistically-significant real-world data, help answer those persistent questions leading to better options and outcomes for patients around the world.