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About Me

Penelope Solis, J.D.

Healthcare Policy & Regulatory Affairs| J.D. | AI Governance | Clinical Quality Registries | Medicare & Medicaid Reimbursement Specialist

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II am a healthcare policy executive and attorney with more than twenty years of experience leading regulatory, policy, and quality initiatives inside major national medical societies, including the American Heart Association, the American College of Cardiology, and ASCO. My work focuses on a clear mission: translating complex federal guidelines and legal frameworks into practical clinical programs, robust registry infrastructure, and sustainable reimbursement strategies.

By bridging the gap between federal agencies like CMS and the FDA, life science innovators, and medical providers, I help clear the regulatory path so that new therapies, medical devices, and digital tools can safely and equitably reach the patients who need them most.

Core Areas of Focus
 

  • CMS Programs and Reimbursement: Navigating intricate federal programs including MACRA, QPP, CMMI, and 340B drug pricing. I specialize in developing state-level landscape assessments, such as Medicaid 1115 waivers and specialized CMS care models, to optimize patient access.

  • Clinical Registry Data Governance: Building compliant registry infrastructure from the ground up. This includes establishing strict SOPs for data collection and ensuring data integrity aligns perfectly with national quality metrics.

  • Healthcare AI Governance: Guiding life science and clinical stakeholders through emerging technology guardrails. I analyze how U.S. health regulations intersect with international standards like the EU AI Act and GDPR to help organizations safely apply AI to clinical trial eligibility and patient care


I am an active member of the D.C. Bar and enjoy leading cross-functional teams through shifting regulatory environments.

Today, I apply this regulatory framework to the intersection of healthcare and Artificial Intelligence. I seek to ensure innovations in technology align with both patient safety and quality improvement efforts. ​

Education

Juris Doctorate 
Boston University School of Law 

Edward F. Hennessey Scholar. Served as Co-Chief of the Legislative Drafting Clinic, specializing in health legislation. This practical foundation in statutory construction underpins my ability to interpret complex federal mandates (CMS, FDA) and design precise governance frameworks for emerging technologies.

Bachelor of Arts, in Political Science 
University of Chicago

Built a rigorous foundation in policy analysis and critical theory. This background provides the essential context for understanding how legislative changes impact downstream clinical stakeholders and registry requirements.

Areas of Expertise

  • Regulatory Strategy

  • AI Governance & Algorithmic Bias

  • Clinical Quality Measure Development & Registry Development 

  • Stakeholder Engagement & Mapping

  • Landscape Analysis

  • Strategic Business Planning & Development

Peer-Reviewed Publications

  1. Tornatore C, Ahmad A, Pham T, Gupte-Singh K, Wahid N, Lynch J, et al. Identification of cognitive impairment, depression, and fatigue among multiple sclerosis patients in a large comprehensive care center: a mixed-methods, qualitative study. Mult Scler Relat Disord. 2022;68:104117. (Credited for Research) Link to Article
     

  2. Belowich E, Pratt KJ, Fifer S, Solis P, Hughes R IV. Increased reimbursement may help overcome barriers to administration of seasonal and routine vaccines. Health Affairs Forefront. December 8, 2020. Link to Article
     

  3. Rosenzweig JL, Conlin PR, Gonzalvo JD, Kutler SB, Maruthur NM, Solis P, et al. 2019 Endocrine Society measures set for older adults with type 2 diabetes who are at risk for hypoglycemia: performance measures for eligible clinicians developed by the Endocrine Society. J Clin Endocrinol Metab. 2020;105(4):969-990. Link to Article
     

  4. Al-Khatib SM, Yancy CW, Solis P, Becker L, Benjamin EJ, Carrillo RG, et al. 2016 AHA/ACC clinical performance and quality measures for prevention of sudden cardiac death: a report of the American College of Cardiology/American Heart Association Task Force on Performance Measures. Circ Cardiovasc Qual Outcomes. 2017;10(2):e000022. Link to Article
     

  5. Heidenreich PA, Solis P, Estes NA III, Fonarow GC, Jurgens CY, Marine JE, et al. 2016 ACC/AHA clinical performance and quality measures for adults with atrial fibrillation or atrial flutter: a report of the American College of Cardiology/American Heart Association Task Force on Performance Measures. Circ Cardiovasc Qual Outcomes. 2016;9(4):443-488. Link to Article
     

  6. Drozda JP Jr, Ferguson TB Jr, Jneid H, Krumholz HM, Nallamothu BK, Olin JW, Solis P, et al. 2015 ACC/AHA focused update of secondary prevention lipid performance measures: a report of the American College of Cardiology/American Heart Association Task Force on Performance Measures. J Am Coll Cardiol. 2016;67(5):558-587. Link to Article
     

  7. Bhatt DL, Drozda JP Jr, Shahian DM, Chan PS, Fonarow GC, Heidenreich PA, et al. ACC/AHA/STS statement on the future of registries and the performance measurement enterprise: a report of the American College of Cardiology/American Heart Association Task Force on Performance Measures and The Society of Thoracic Surgeons. Circ Cardiovasc Qual Outcomes. 2015;8(6):634-648. Link to Article
     

  8. Fonarow GC, Alberts MJ, Broderick JP, et al. Stroke outcomes measures must be appropriately risk adjusted to ensure quality care of patients: a presidential advisory from the American Heart Association/American Stroke Association. Stroke. 2014;45(5):1589-1601. Link to Article
     

  9. Schwamm LH, Fayad P, Acker JE III, Duncan P, Fonarow GC, Girgus M, Solis P, et al. Translating evidence into practice: a decade of efforts by the American Heart Association/American Stroke Association to reduce death and disability due to stroke: a presidential advisory from the American Heart Association/American Stroke Association. Stroke. 2010;41(5):1051-1065. Link to Article
     

  10. Jacobs AK, Antman EM, Faxon DP, Gregory T, Solis P. Development of systems of care for ST-elevation myocardial infarction patients: executive summary. Circulation. 2007;116(2):217-230. Link to Article
     

  11. Acker JE III, Pancioli AM, Crocco TJ, Eckstein MK, Jauch EC, Larrabee H, Solis P, et al. Implementation strategies for emergency medical services within stroke systems of care: a policy statement from the American Heart Association/American Stroke Association Expert Panel on Emergency Medical Services Systems and the Stroke Council. Stroke. 2007;38(11):3097-3115. Link to Article

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