Helping healthcare companies navigate regulatory hurdles

Simone Colgan Dunlap advises on regulatory compliance, related risk management and corporate/contracting matters for a variety of clients, including drug and device manufacturers, pharmacy benefits managers (PBM), third-party administrators (TPA), healthcare insurers, discount medical plan organizations (including prescription discount card administrators), pharmacies, specialty pharmacies, home health agencies, hospitals, physician organizations, physicians, pharmacists and nurses. She advises on a full range of issues, including:

• Healthcare agreements
• Healthcare regulatory compliance
• Health privacy
• Structuring and drafting agreements for novel healthcare products and services

Simone understands the business needs of healthcare companies and the constantly shifting regulatory environment in which they operate. She is national chair of the firm's Health & Life Sciences Industry Team.

Bar Admissions

• Arizona

Education

• University of Michigan Law School (J.D., cum laude, 2008)
  • University of Michigan Journal of International Law, business development editor

• Whitman College (B.A., with honors, 2002)

• "Big Data, Big Risk: Strategies to Mitigate Risks Associated with Data Monetization"
• "COVID-19 and Increased Cyber Risk"
• "COVID-19 and the risks of an expanded remote workforce"
• "Discounts, & Rewards & Loyalty Programs, Oh My"
• "Double, Double Toil and Trouble: Avoiding Regulatory Pitfalls Related to Thy Hubs Interactions"
• "Double, Double Toil, and Trouble: Avoiding Regulatory Pitfalls Related to Thy Hubs Interactions"
• "Examining the Law on Health Information and COVID-19 for Businesses"
• "Federal District Court in Eleventh Circuit Holds that Failure to Allege Actual Submission of a Specific False Claim is Fatal to an Off-Label Use Marketing Qui Tam Suit"
• "Health Care Reform: A Look Back and A Way Forward"
• "Health Law"
• "Hot Button Issues on PBMs' Radars"
• "Hot Topics in Pharmacy Law"
• "How COVID-19 increases cyber risk and tips to protect yourself"
• "Legal Issues in Specialty Pharmacy"
• "NASP presentation: Lunch with a Lawyer: Privacy Please! Recent developments in federal and state privacy laws that impact specialty pharmacy"
• "Paying for Performance: Understanding Key Issues in Risk Sharing Agreements"
• "Pharmacy 101"
• "Pharmacy Law-Examination and Board Review: Arizona Chapter"
• "Special report: How COVID-19 could reshape telemedicine sector in Arizona, US"
• "Specialty Pharmacy and the Law"
• "Specialty Pharmacy"
• "State Health Care Fraud Law: An AHLA 50-State Survey with Summaries and Links"
• "Summary of Fraud and Abuse Statutes and Regulations, Rhode Island"
• "Telemedicine: The Role of Technology and Changing Laws in the Delivery of Cancer Care"
• "The Acceleration of Technology"
• "The Cost of Coupons: Implications of Recent OIG Guidance on Pharmaceutical Manufacturer Copayment Coupons"
• "The Dating Game: Navigating Relationships with Pharmaceutical Manufacturers"
• A Prescription for Caution: Senators Release Investigative Report on Direct-To-Consumer Telehealth Models
• Alabama Board of Pharmacy Imposing 3:1 Technician to Pharmacist Ratio on Non-Resident Pharmacies
• Arkansas Law Prohibits Pharmacy Benefit Managers from Obtaining or Holding Pharmacy Permits
• Arkansas' PBM Law Upheld By Supreme Court
• Beware of Individuals Impersonating the Arizona State Board of Pharmacy (or other Regulators)
• California Board of Pharmacy Changes
• California Passes Two Drug Pricing Transparency Laws
• CMS Proposed Rule to Delay Effective Date of Amended Regulatory Definitions under the Medicaid Drug Rebate Program
• Compliance Eve Ends with HIPAA Reproductive Health Privacy Rule Order out of Texas: But is it a Gift or Lump of Coal for Regulated Entities?
• District Court Judge Dismisses Texas HIPAA Privacy Rule Lawsuit: We Are Thankful for HIPAA
• Diving into the Washington My Health My Data Act
• Diving into the Washington My Health My Data Act
• Diving into the Washington My Health My Data Act
• Diving into the Washington My Health My Data Act
• DOJ Launches West Coast Health Care Fraud Strike Force: Implications for Telehealth, Behavioral Health, and Specialty Pharmacy Companies
• Fraud in the Time of Corona: Beware of Individual Impersonating OCR Investigator
• HHS OCR Withdraws Tracking Technologies Appeal in AHA v. Becerra
• HHS Office for Civil Rights Announces Proposed Rule Increasing HIPAA Privacy Rule Protections for Reproductive Care
• HIPAA Reproductive Health Care Privacy - New Administration Evaluating Its Position
• It's the End of the PHE as We Know It
• Key Considerations for Healthcare Providers Responding to Law Enforcement Requests
• Massachusetts Drug Discount Provision Set to Expire January 1, 2020
• Massachusetts Law Permitting Pharmacies and Pharmaceutical Manufacturers to Offer Drug Discounts to Consumers Extended to January 1, 2026
• Massachusetts Law Permitting Pharmacies and Pharmaceutical Manufacturers to Offer Drug Discounts to Consumers Extended to January 1, 2031
• Massachusetts Passes Emergency Opioid Legislation
• Massachusetts' Court Creates a New Duty for Pharmacies to Notify Prescribers of Prior Authorization Requirements
• Meghan O'Connor, Sarah Erdmann and Simone Colgan Dunlap Outline Implications of HIPAA-Related Settlement in Article for Journal of Health Care Compliance
• Meghan O'Connor, Simone Colgan Dunlap, Sarah Erdmann and Kaitlyn Fydenkevez Author ABA Article About New Reproductive and Sexual Health Privacy law and Its Potential Broad Applicability and Operational Challenges
• New Limitations on Chain Pharmacy Quotas in California
• New York State Department of Financial Services Reporting Requirements for Pharmacy Benefit Managers
• Ohio Board of Pharmacy Formalizes a Pathway for Approval of Innovative Pharmacy Arrangements
• Oklahoma Patient's Right to Pharmacy Choice Act Preempted by ERISA
• Planning for Preparedness and Response: COVID-19 Response for the Health and Life Sciences Industry
• Privacy and Cybersecurity Considerations and Opportunities Related to COVID-19
• Rhode Island Pharmacist Drug Administration Expansion
• Rhode Island: Summary of Fraud and Abuse Statutes and Regulations
• Safeway Prevails on Motion for Summary Judgment in Whistleblower Pharmacy Usual and Customary Pricing Case
• Simone Colgan Dunlap and Kiel Zillmer Write Article for Thomson Reuters on Health Care Fraud and Abuse Laws in Wisconsin
• Takeaways from First Washington My Health My Data Act Complaint
• Texas Attorney General Obtains Settlement of Alleged False and Misleading Statements About Healthcare Artificial Intelligence Product Accuracy
• The OIG Green Lights Brand Manufacturer's Discount Drug Program
• Trade Group Sues State of California to Block S.B. 17 Drug Pricing Bill
• Trump Administration Rescinds HHS Guidance on Privacy of Gender Affirming Care Data
• Utah Authorizes AI-Based Prescription Renewals
• Winter Blues Client Alert Series: Privacy Concerns in the Collection and Use of Biometric Data
• ​What's So Special About Specialty Pharmacy? What Hospitals and Health Systems Need to Know About Specialty Pharmacy Integration
• "Circling Back" After the New Year: Recent Updates in Data Privacy & Security

Seminar

• 2015 Pharmacy Law Symposium
• 2018 Pharmacy Law Symposium
• 2021 Pharmacy Law Symposium
• 2023 Pharmacy Law Symposium
• 2025 Pharmacy Law Symposium
• 2026 Pharmacy Law Symposium
• American Society for Pharmacy Law (ASPL) 2020 Virtual Fall Meeting
• Artificial Intelligence and the Practice of Pharmacy
• Artificial Intelligence Webinar Series
• Celebrate Privacy Day with Quarles!
• For Your Eyes Only: Managing Data in the Pharmaceutical and Clinical Trial Industries
• Hot Button Issues on PBMs' Radars
• It's the End of The World as We Know It: Artificial Intelligence in Specialty Pharmacy
• NASP 2019 Annual Meeting & Expo 4th Annual Specialty Pharmacy Law Conference
• NASP 2020 Annual Meeting & Expo Virtual Experience and 5th Annual Specialty Pharmacy Law Conference
• Navigation Regulation of Artificial Intelligence
• NCPDP Annual Conference
• Privacy (and Security) Please! Hot Topics in Pharmacy
• Privacy Day 2025 - Take Your Privacy Game to the Next Level
• Privacy Developments on the Horizon for 2024
• Quarles' 17th Annual Specialized CLE for In‑House Counsel
• Regulatory Disruption and Distribution Evolution - Redefining Patient Access in the Modern Hub
• Specialty Pharmacy Law: AI
• State of the Law in Specialty Pharmacy
• State Pharmacy Licensure & Compliance
• Telemedicine: The Role of Technology and Changing Laws in the Delivery of Cancer Care
• Trending Legal Issues Roundtable
• Under Pressure: A Musical Journey to Understanding the Legal Framework Necessary to Leverage Big Data - 2022 ACC Annual Meeting
• What's Next? An Analysis of What the Notice of Proposed Rulemaking for the HIPAA Security Rule Means for Industry