Arushi Pandya

Arushi Pandya is an associate in the Governmental Practice and a member of the Healthcare and Life Sciences teams.

Areas of Practice

Arushi advises on regulatory, compliance, and operational matters affecting the healthcare and life sciences industries.

In her healthcare regulatory practice, Arushi provides guidance on a variety of federal and state issues including digital health and telehealth, privacy, compliance programs, licensure and scope of practice, EMTALA, fraud and abuse (including the Anti-Kickback Statute, Civil Monetary Penalties Law, and Stark Law), corporate practice of medicine, billing and reimbursement, as well as internal and governmental investigations.

In her FDA regulatory practice, Arushi assists clients with privacy and data security issues, life sciences transactions (including clinical trial and investigator agreements), state licensure issues, developing policies and procedures for comprehensive compliance programs, advertising and promotion, sampling issues, and internal investigations. She also assists pharmaceutical, biotechnology, and medical device companies comply with pre-market and post-market FDA requirements.

Arushi also advises healthcare and life sciences entities on privacy and digital health matters such as artificial intelligence, third-party web tracking, breach response, and a range of privacy and security laws, including HIPAA and other federal and state privacy laws.

Articles

Healthcare Law Blog Posts

• "Women’s Health on the Ballot in November: What the Election Could Mean for Reproductive Care and Beyond," October 4, 2024

• "Key Telehealth Updates in the CY 2025 Physician Fee Schedule Proposed Rule," September 5, 2024

• "SCOTUS Punts on EMTALA Preemption Question," July 19, 2024
• "EMTALA: In the Spotlight," June 3, 2024

• "CMS Issues CY2025 Medicare Advantage and Part D Final Rule," April 15, 2024

• "CMS Promotes Competition, Transparency, Health Equity and More in the CY2025 Medicare Advantage and Part D Proposed Rule," November 13, 2023

• "Caught in the Web: Hospital Associations Sue OCR on Third-Party Web Tracking Guidance," November 7, 2023

• "Tele-Prescribing Flexibilities Extended Again in Second Temporary Rule," October 17, 2023
• "EMTALA and Pregnancy Care Remains a Federal Enforcement Priority," May 17, 2023
• "DEA and SAMHSA Extend Tele-Prescribing Flexibilities," May 12, 2023

• "DEA Proposes Rule for Post-PHE Telemedicine," March 7, 2023
• "Telehealth in a Post-PHE World," March 3, 2023
• "CMS Updates List of Telehealth Services for CY 2023," February 28, 2023
• "Web Tracking Creates a Web of Data Privacy Risks," February 8, 2023

• "The Transformation in Behavioral Digital Health Services," January 31, 2023

• "Key Healthcare Provisions of the Consolidated Appropriations Act, 2023," January 6, 2023

• "Recent Developments in Telehealth Enforcement," December 12, 2022

• "The FemTech Revolution," October 11, 2022 
• "EMTALA in the Post-Dobbs World," September 13, 2022

• "OIG Issues Favorable Advisory Opinion For Federally Qualified Health Center’s Smartphone Loan Program," August 11, 2022

• "Supreme Court To Review DOJ’s Authority to Dismiss Qui Tam FCA Suits Over Objections From Relators," June 30, 2022
• "OIG Issues Favorable Advisory Opinion for Physician-Owned Medical Device Company," June 27, 2022
• "Digital Health in the Metaverse: Three Legal Considerations," May 31, 2022
• "HHS OIG Report On Prior Authorizations Under Medicare Advantage," May 5, 2022
• "CMS Begins Option to Extend Medicaid Postpartum Coverage," April 6, 2022

FDA Law Blog Posts

• "DOJ Updates Guidance on Evaluation of Corporate Compliance Programs," October 29, 2024

• "FDA Revisits and Updates Guidance on Addressing Misinformation – Ten Years Later," July 16, 2024
• "OIG Issues Favorable Advisory Opinion Regarding Patient Assistance Funds," May 8, 2024

• "Time to Refresh? FDA Issues Draft Guidance on Key Information and Informed Consent," March 19, 2024

• "2024 Top-of-Mind Issues for Life Sciences Companies," January 25, 2024

• "FDA Approves First Over-the-Counter Daily Oral Contraceptive," August 3, 2023

• "FDA Issues Warning Letter to RightEye, LLC For Misbranding and Adulteration," February 13, 2023

• "FDA Proposes Updated Rule for “Healthy” Foods," October 27, 2022

• "FDA Issues Untitled Letter to Althera Pharmaceuticals for Statements Relating to ROSZET®," June 23, 2022
• "Digital Health in the Metaverse: Three Legal Considerations," June 3, 2022

Government Contracts and Investigations Law Blog Posts

• "Supreme Court To Review DOJ’s Authority to Dismiss Qui Tam FCA Suits Over Objections From Relators," June 29, 2022
• "HHS OIG Report On Prior Authorizations Under Medicare Advantage," May 27, 2022

Events

Digital Media