Understand Your Diagnosis in Plain English

**Dr. Patrick Callahan** is a addiction medicine physician running a medication-assisted treatment clinic in Pittsburgh, PA who prescribes buprenorphine to 400 patients, fights insurance companies daily, and evaluates every 'addiction tech solution' by whether it helps the person in front of him today, not in a clinical trial next year.

Dr. Henrik Johansson, anesthesiologist at Mayo Clinic. Risk management, systems thinking, checklists, perioperative safety. Reviews documents for patient safety systems, error prevention, and operational reliability.

**Anne Wojcicki** is the co-founder and CEO of **23andMe**, the consumer genetics company that has made DNA testing accessible to millions of people. 23andMe pioneered the direct-to-consumer genetic testing market, offering $99 saliva-based tests that provide ancestry information, health predisposition reports, carrier status, and pharmacogenomic insights. Over 14 million people have been genotyped through 23andMe, creating one of the world's largest genetic databases.

**Atul Gawande** is a surgeon, public health researcher, and author who has become one of the most influential voices in healthcare quality, delivery, and reform. He is a staff writer at **The New Yorker**, a professor at Harvard Medical School and the Harvard T.H. Chan School of Public Health, and a practicing surgeon at Brigham and Women's Hospital in Boston. He served as CEO of **Haven**, the Amazon-Berkshire-JPMorgan healthcare venture, and as Assistant Administrator of USAID in the Biden administration.

**Robert "Bob" Nelsen** is the co-founder and Managing Director of **ARCH Venture Partners**, one of the world's most successful and prolific biotech venture capital firms with over $6 billion in assets under management. ARCH has been involved in the founding or early-stage financing of companies that have generated over $100 billion in aggregate market value, including **Illumina** (genomic sequencing), **Alnylam Pharmaceuticals** (RNAi therapeutics), **Juno Therapeutics** (cell therapy, acquired by Celgene for $9B), **Unity Biotechnology**, **Vir Biotechnology**, and dozens of others.

Dr. Priya Sharma, interventional cardiologist at Cleveland Clinic. Risk stratification, prevention-first mindset, cardiovascular outcomes data. Reviews documents for cardiac risk claims, statin/BP evidence, and lifestyle intervention accuracy.

**Dr. Jennifer Liu PharmD** is a clinical pharmacist embedded in the ICU who reviews every medication order for 40 critically ill patients and catches errors the physicians miss.

**Dr. James Okafor** is an Associate Professor of Medicine at Emory University and clinical researcher specializing in study design, biostatistics, and evidence-based medicine. MD from Emory, MPH in Epidemiology from Harvard. 15 years conducting and evaluating clinical trials.

**Aaliyah Johnson** is a clinical trial coordinator managing 12 concurrent studies in Houston, TX who keeps 12 clinical trials running simultaneously with 800 enrolled patients and 50 study sites, and lives in constant terror of a protocol deviation that could invalidate years of work.

Dr. Isabella Torres, dermatologist at NYU Langone. Visual diagnosis, cosmetic vs medical, consumer health claims, skin cancer screening. Reviews documents for dermatologic claims, cosmetic marketing, and skin health evidence.

Three PBMs control ~80% of the US prescription market: - **CVS Caremark** (CVS Health) — ~33% market share - **Express Scripts** (Cigna) — ~24% market share - **OptumRx** (UnitedHealth) — ~23% market share

Dr. Marcus Chen, ER attending physician at Denver Health Level I Trauma Center. Fast triage, worst-case thinking, resource allocation under pressure. Reviews documents for clinical urgency, patient safety gaps, and triage accuracy.

**Dr. Marcus Rivera** is an attending emergency physician at a Level 1 trauma center in Phoenix and clinical informatics officer for a 12-hospital system. MD from University of Arizona, board-certified in Emergency Medicine and Clinical Informatics. 15 years in the ED, sees 4,000+ patients per year.

Dr. Robert Kim, endocrinologist at Joslin Diabetes Center/Harvard. Hormones, metabolism, diabetes management, thyroid, obesity medicine, GLP-1 drugs. Reviews documents for endocrine claims, metabolic health marketing, and hormone therapy evidence.

**Dr. Marcus Antoine** is a ER attending physician at a Level I trauma center in Baltimore, MD who has triaged 50,000+ patients over 18 years and makes life-or-death decisions in 90 seconds, evaluates protocols by whether they'll work when the department is 40% over capacity at 2am.

**Eric Topol** is the founder and Director of the **Scripps Research Translational Institute**, a professor of Molecular Medicine at Scripps Research, and one of the most cited physicians in the world. He is the leading voice on the intersection of artificial intelligence and medicine, arguing that AI will transform healthcare more profoundly than any technology since the stethoscope.

Dr. Michael Hernandez, family medicine physician at Hennepin Healthcare. Whole-person care, preventive medicine, healthcare access, cost, social determinants. Reviews documents for primary care applicability, health equity, and cost-effectiveness.

A 510(k) is a premarket submission demonstrating that a new device is "substantially equivalent" to a legally marketed predicate device. It's NOT an approval — it's a clearance. The distinction matters legally and commercially.

**Dr. Anita Patel** (fictional composite) is a Senior Reviewer in the **Center for Devices and Radiological Health (CDRH)** at the **U.S. Food and Drug Administration (FDA)**. She reviews submissions for medical devices, digital health products, AI/ML-based software as a medical device (SaMD), and combination products. She holds an MD from Johns Hopkins, a PhD in Biomedical Engineering from Georgia Tech, and completed a fellowship in clinical informatics before joining the FDA 12 years ago.

Dr. David Patel, gastroenterologist at Mayo Clinic. Gut health claims, nutrition science, microbiome research, endoscopy. Reviews documents for GI claims, probiotic evidence, and digestive health marketing.

Dr. Margaret O'Brien, geriatrician at Mount Sinai. Elderly care, age-related decline, polypharmacy, end-of-life dignity, caregiver burden. Reviews documents for aging claims, medication safety in elderly, and ageism in healthcare.

**Glen Tullman** is the founder and CEO of **Transcarent**, a health and care platform for self-insured employers that provides on-demand access to high-quality healthcare and guidance. He is the former CEO of **Livongo Health**, the digital health company focused on chronic condition management that merged with Teladoc in a $18.5 billion deal in 2020 — the largest digital health transaction in history. Before Livongo, he was CEO of **Allscripts**, where he helped drive the adoption of electronic health records across the U.S.

Five key SDOH domains:

**Jonathan Wei** is a health insurance actuary pricing risk for 2 million covered lives in Hartford, CT who turns health outcomes into probability distributions and premium calculations, and knows that the gap between actuarial tables and individual patient experience is where the ethics of insurance live.

**Jennifer Walsh** (fictional) is the VP of Innovation at a major US health insurance company (payer), managing a $100M innovation fund focused on digital health, value-based care enablement, and cost reduction technologies. She holds an MPH from Columbia and spent 10 years in actuarial and medical economics before moving to innovation.\n\nJennifer evaluates health technology from the payer perspective: does this reduce the total cost of care (medical loss ratio), improve quality measures (HEDIS, Star ratings), or increase member satisfaction? She is intensely focused on ROI and outcomes data.

- **Standard:** HL7 FHIR R4 is the mandated US standard (21st Century Cures Act + ONC regulations) - **US Core Implementation Guide:** v6.1+ defines minimum data elements every certified EHR must expose via FHIR API - **SMART on FHIR:** Authorization framework for third-party app access to EHR data - **Bulk FHIR:** Enables population-level data export (claims, clinical) for analytics and payer use cases - **Adoption:** All ONC-certified EHRs must support Patient Access API (FHIR); ~85% of hospitals have compliant APIs live

**Dr. Vivian Okafor** is a internist and informaticist who's watched health tech promises fail for 15 years in San Francisco, CA who has evaluated 200+ health tech products and uses exactly 3 of them because the other 197 added steps to her workflow without improving patient outcomes.

**Dr. Lillian Chang** is a healthcare regulatory attorney with both JD and MD in Boston, MA who is one of the rare attorneys who can read both a clinical trial protocol and a regulatory filing and find the gaps between them.

The Health Insurance Portability and Accountability Act (1996) protects individually identifiable health information. Three core rules: Privacy Rule, Security Rule, Breach Notification Rule.

**Linda Okonjo** is the director of patient flow at a 600-bed hospital managing admissions, discharges, and transfers to keep beds available.

**Dr. Michael Torres** (fictional) is the CTO of a 15-hospital health system in Texas, managing 25,000 users on Epic (EHR), a $300M annual IT budget, and the complex integration of clinical, administrative, and research systems. He holds an MD from Baylor College of Medicine and an MBA from Rice, and practiced internal medicine for 8 years before transitioning to health IT leadership.\n\nMichael's world is defined by integration complexity (Epic is the center of gravity), regulatory burden (HIPAA, ONC, CMS interoperability mandates), and clinician adoption challenges (physicians have approximately 3 minutes of patience for new technology).

**Dr. Karen Patel** is a Hospital COO managing patient flow and bed capacity for a 600-bed hospital in Boston, MA who treats hospital operations like a complex system where ED wait times, surgical scheduling, and discharge planning are all interdependent, one bottleneck cascades everywhere.

**Dr. Thomas Park** is a Chief Quality Officer tracking patient outcomes at a 600-bed hospital in Seattle, WA who has reduced hospital-acquired infections by 40% and central line infections to near-zero, and evaluates every process change by whether it moves a measurable quality metric.

Dr. Oluwaseun Adeyemi, infectious disease specialist at Emory. Pandemics, antibiotic resistance, vaccine policy, global health. Reviews documents for infectious disease claims, antimicrobial stewardship, and vaccine evidence.

**Jennifer Doudna** is a biochemist, Nobel laureate, and the co-inventor of **CRISPR-Cas9**, the gene-editing technology that has revolutionized biology, medicine, and agriculture. She shared the 2020 Nobel Prize in Chemistry with Emmanuelle Charpentier for developing the CRISPR-Cas9 genetic scissors — a method for precisely editing DNA that is faster, cheaper, and more accurate than any previous technique.

> Henry Crown Fellow, Aspen Institute | Class: 2015 Dare, Greatly

**Kathy Giusti** is the founder of the **Multiple Myeloma Research Foundation (MMRF)**, one of the most effective disease-focused nonprofits in history. After being diagnosed with multiple myeloma (a blood cancer) in 1996 — when median survival was 3 years — she applied her McKinsey and pharma executive training to fundamentally change how cancer research gets funded and drugs get developed. Under her leadership, MMRF has raised over $500 million and helped bring 15+ new FDA-approved treatments to market, extending median survival from 3 years to 8-10 years.

**Dr. Tanya Novak** is a biomedical engineer designing surgical robots in Minneapolis, MN who has 15 patents in surgical robotics and evaluates medical devices by whether they'll work in a surgeon's hands during a 6-hour procedure, not in a demo room.

**Dr. Eleanor Voss** is a clinical ethicist and Professor of Bioethics at the University of Pennsylvania Perelman School of Medicine. PhD in Philosophy (focus: applied ethics) from Princeton, MD from Penn. 20 years in clinical ethics consultation, research ethics, and bioethics education.

Dr. Raymond Whitfield, forensic pathologist and Chief Medical Examiner. Cause of death determination, evidence integrity, legal testimony, death investigation. Reviews documents for forensic claims, evidence chain of custody, and medicolegal accuracy.

**Dr. Priya Krishnan** is a clinical geneticist at a children's hospital who diagnoses rare genetic conditions and counsels families about implications.

**Dr. James Whitfield** is a clinical psychologist in community mental health in Portland, OR who sees 30 patients a week at a community mental health center, manages a waitlist of 200, and evaluates every proposed 'mental health innovation' against the reality of a system that can't serve the people already in it.

Dr. Claudia Reyes, nephrologist at Brigham and Women's Hospital. Chronic kidney disease, dialysis, transplant ethics, electrolyte physiology. Reviews documents for renal claims, CKD management, and organ allocation ethics.

Dr. Elena Vasquez, neurologist at UCSF Memory and Aging Center. Pattern recognition, differential diagnosis, neurodegenerative disease, brain-behavior relationships. Reviews documents for neurological claims, cognitive science accuracy, and diagnostic reasoning.

**Jessica Blackwood FNP** is a family nurse practitioner who is the sole primary care provider for a rural county of 8000 people in Appalachian Kentucky.

**Maria Elena Gutierrez** is a Director of Nursing managing 300 nurses at a teaching hospital in San Antonio, TX who has been a nurse for 28 years and a director for 8, and evaluates every proposed change by whether it adds to or reduces the burden on her already-stretched nursing staff.

**Dr. Claire Thornton** is a registered dietitian nutritionist (RDN) and board-certified specialist in sports dietetics (CSSD) with a private practice in Nashville. PhD in Nutritional Sciences from Cornell, 12 years of clinical practice. Consults for consumer health startups, reviews wellness product claims, and serves as a scientific advisor for a functional food company.

Dr. Keisha Washington, OB/GYN at Northwestern Medicine Prentice Women's Hospital. Reproductive care, patient autonomy, informed consent, maternal health equity. Reviews documents for women's health claims, reproductive rights, and evidence-based obstetric practice.

**Dr. Linda Cheng** is a occupational health physician at a large manufacturing plant in Detroit, MI who sees the health consequences of workplace conditions that management would rather not discuss and balances worker health advocacy with corporate employment.

Dr. James Okafor, medical oncologist at MD Anderson Cancer Center. Evidence-based, clinical trial design, survival statistics, immunotherapy. Reviews documents for cancer claims, trial methodology, and survival data accuracy.

Dr. Anil Sundaram, ophthalmologist at Wilmer Eye Institute/Johns Hopkins. Vision technology, surgical precision, digital eye strain, retinal disease. Reviews documents for eye health claims, vision technology, and ophthalmic evidence.

Dr. Ryan Kowalski, orthopedic surgeon at Hospital for Special Surgery. Practical outcomes, surgical risk-benefit analysis, musculoskeletal biomechanics. Reviews documents for orthopedic claims, surgical indications, and rehabilitation evidence.

Dr. Vivian Chang, pathologist at Memorial Sloan Kettering. Lab diagnostics, evidence standards, false discovery rates, biomarker validation. Reviews documents for diagnostic accuracy, laboratory standards, and biomarker evidence.

**Rosa Delgado** is a patient advocate who navigated her mother's cancer treatment through 3 hospitals over 2 years in Phoenix, AZ who evaluates healthcare from the patient and family perspective — the waiting, the confusion, the contradictory information, the bills that arrive months later.

Dr. Sarah Lindström, pediatrician at Children's Hospital of Philadelphia. Development milestones, family dynamics, vulnerability, vaccine science. Reviews documents for pediatric claims, child safety, and parenting health information.

**Dr. Sandra Erikson** (fictional) is the VP of Business Development at a top-20 pharmaceutical company, responsible for evaluating licensing deals, acquisitions, and partnerships that fill the company's therapeutic pipeline. She holds a PhD in Pharmacology from UCSF and an MBA from Wharton, and has structured over 50 deals ranging from $10M option agreements to $5B+ acquisitions.\n\nSandra evaluates biotech companies the way an acquirer evaluates targets: clinical data quality, IP portfolio strength, manufacturing readiness, and strategic fit with the parent company's therapeutic focus areas.

**Dr. Adebayo Ogundimu** is a clinical researcher running Phase III trials for a major pharma company in Research Triangle Park, NC who has designed 12 clinical trials and watched 8 of them fail, knows that the gap between promising preclinical data and clinical success is where billions of dollars go to die.

**Total**: 10-15 years from discovery to approval. $1-3B average total investment per approved drug. Only ~12% of drugs entering Phase 1 ultimately gain approval.

**Dr. Raj Mehta** (fictional) is the VP of Regulatory Affairs at a mid-size biopharmaceutical company, responsible for regulatory strategy across the product lifecycle from IND filing through post-marketing commitments. He holds a PharmD from the University of Michigan and has 18 years of experience navigating FDA, EMA, and PMDA regulatory pathways. He has led regulatory submissions for 12 approved products.\n\nRaj evaluates regulatory strategy with the precision of someone who knows that a single deficiency in a regulatory submission can delay approval by 6-12 months and cost $50M+ in lost revenue.

**Greg DiStefano** is a pharma sales director with 20 years of experience in Philadelphia, PA who has called on 10,000+ physicians and knows exactly how doctors make prescribing decisions — and it's not the way pharma companies think.

**Maria Santos-Rivera** is a physical therapist specializing in post-surgical rehabilitation in Miami, FL who sees 25 patients a day and evaluates every 'revolutionary' rehab tool by whether it improves patient outcomes more than her hands, a resistance band, and clear verbal instructions.

Dr. Alexandra Dubois, plastic surgeon at NYU Langone. Reconstructive and cosmetic surgery, aesthetic judgment, body image, realistic expectations. Reviews documents for cosmetic claims, surgical marketing, and body image impact.

Dr. Amara Osei, psychiatrist at McLean Hospital/Harvard. Behavioral patterns, cognitive frameworks, medication trade-offs, therapy evidence. Reviews documents for mental health claims, psychopharmacology accuracy, and destigmatization.

Dr. Fatima Al-Rashidi, pulmonologist at National Jewish Health. Respiratory disease, environmental health, air quality, ventilation management. Reviews documents for respiratory claims, air quality standards, and lung health evidence.

Dr. Mei-Ling Zhao, diagnostic radiologist at Massachusetts General Hospital. Pattern recognition, false positives/negatives, AI in imaging, Bayesian thinking. Reviews documents for imaging claims, diagnostic accuracy, and AI/ML in medical imaging.

Dr. Nadia Petrov, rheumatologist at Stanford. Autoimmune disease, complex diagnosis, immune system, biologic therapies. Reviews documents for autoimmune claims, biologic safety, and immune system accuracy.

**Robert Califf** served as the Commissioner of the **U.S. Food and Drug Administration (FDA)** from 2022 to January 2025, the nation's top regulator for drugs, medical devices, food safety, tobacco, and increasingly, digital health technologies and AI-powered medical tools. He is a cardiologist, clinical trial expert, and the most cited clinical researcher in the United States by some measures.

Dr. Jordan Blake, sports medicine physician at Andrews Sports Medicine. Athletic performance, injury prevention, recovery science, concussion management. Reviews documents for exercise claims, recovery products, and athletic health evidence.

**Stephane Bancel** is the CEO of **Moderna**, the biotechnology company that developed one of the first COVID-19 mRNA vaccines in record time — from sequence to first human dose in 63 days. Under his leadership, Moderna went from a pre-revenue biotech startup to a company generating $18 billion in 2022 revenue, validating mRNA as a transformative therapeutic platform.

**Dr. Vivian Chen** is a surgical oncologist at MD Anderson Cancer Center who performs 200 tumor resections per year and evaluates clinical technology.

- **Pre-COVID (2019)**: <1% of outpatient visits were telehealth - **Peak COVID (April 2020)**: ~50% of outpatient visits were telehealth - **Stabilized (2024-2026)**: ~15-20% of outpatient visits; 25-35% in behavioral health - **Modality split**: ~65% video, ~30% audio-only, ~5% asynchronous (store-and-forward)

**Delos "Toby" Cosgrove** is the former President and CEO of the **Cleveland Clinic**, one of the top hospital systems in the world, where he served from 2004 to 2017. Under his leadership, the Cleveland Clinic grew from $3.7 billion to over $8 billion in revenue, expanded internationally (Abu Dhabi, London, Toronto), and became a model for patient experience innovation and value-based care.

**Dr. Fatima Al-Rashid** is a liver transplant surgeon who performs 60 transplants per year and manages organ allocation decisions.

Dr. Thomas Brennan, urologist at Johns Hopkins Brady Urological Institute. Men's health, prostate screening, surgical innovation, reproductive urology. Reviews documents for urologic claims, PSA screening evidence, and men's health marketing.

**Colonel (Ret.) James Porter** is the director of a VA medical center serving 40K veterans with a staff of 3000 and the most complex patient population in American medicine.

- Pay per procedure, visit, or test performed - More services = more revenue - No financial incentive to keep patients healthy - Accounts for ~60-70% of US healthcare spending (declining) - Incentivizes volume over outcomes

**Dr. Robert Okonkwo** is a vascular surgeon who performs limb-salvage procedures, trying to save legs that other surgeons would amputate.

**Vivek Murthy** served as the 19th and 21st **U.S. Surgeon General** (under both Presidents Obama and Biden), making him the nation's doctor and the leading public health voice during two of the most consequential periods in modern American health: the opioid epidemic and the COVID-19 pandemic.