Erin M. Duffy
Associate
Duane Morris LLP
30 South 17th Street
Philadelphia, PA 19103-4196
USA
Phone: +1 215 979 1946
Fax: +1 215 689 4913
Email: EMDuffy@duanemorris.com

Erin M. Duffy concentrates her practice on corporate healthcare regulatory matters. She advises clients on a wide range of issues, including fraud and abuse, self-referral, Medicare and Medicaid reimbursement, corporate practice of medicine and fee-splitting prohibitions, tax-exempt status, and certificate of need and licensure issues. She is also experienced in handling healthcare information technology matters, including mobile (MHealth) and electronic health records.

Ms. Duffy is a graduate of Temple University Beasley School of Law and St. Joseph's University.

Areas of Practice

• Healthcare Law
  - Federal and State Healthcare Licensure
  - Medicare and Medicaid Reimbursement Issues
  - Anti-kickback and Physician Self-referral Regulation (Stark)
  - HIPAA and Privacy Issues
  - Special Hospital Formation and Compliance
  - Physician-Owned Healthcare Businesses
  - FDA Pharmaceutical and medical device regulations
  - MHealth Technology
• Healthcare Litigation
  - Fraud and Abuse
  - False Claims Act
  - Reimbursement

Representative Matters

• Restructured two physician-owned specialty hospitals and a physician group practice into a unified health care system, including corporate, licensing and regulatory issues.
• Represented a holding company in the simultaneous acquisition of eighteen skilled-nursing facilities, 5 personal care homes and four home health agencies, including all licensing and regulatory issues.
• Counseled third-party administrator on compliance issues related to state and HIPAA Breach Notification requirements in all 50 states as a result of a data breach involving personally identifiable health information.
• Conducted internal investigation of a hospital's policies, procedures and employment practices following the arrest of a non-employed physician on sexual abuse charges. (Jane Doe 30, et al. v. Earl Bradley, M.D., et al.)
• Appellate Counsel, Cooper Univ. Hospital v. Jacobs (N.J.), represented hospital defending Certificate of Need (CON) to participate in elective angioplasty demonstration project against appeal by competing hospital.
• Counsel, U.S. ex rel. Kite v. Lourdes Health System, et al., (D.N.J.), defense of hospitals regarding allegations of improper receipt of outlier reimbursement from Medicare.

Professional Activities

• Food and Drug Law Institute
  -Update Editorial Advisory Board

Admissions

• Pennsylvania
• New Jersey
• Supreme Court of the United States

Education

• Temple University Beasley School of Law, J.D., cum laude
• St. Joseph's University, B.A., summa cum laude

Experience

• Duane Morris LLP
  - Associate, 2004-present

Board Memberships

• Academy of Notre Dame de Namur
  - Trustee, 2008-present
  - Member, Finance Committee, 2005-2008

Civic and Charitable Activities

• Public Interest Law Center of Philadelphia
  - Member, Medicaid Policy Circle

Honors and Awards

• Pennsylvania Rising Star, 2011-2013

Selected Publications

• Co-author, "mHealth Revenue Models: Finding the Right One for the Right App," mHealth Newsletter, June 26, 2013
• Co-author, "FDA Enforcement Action Against uChek: Does It Signal an Agency Wake-up Call for Non-compliant Mobile Medical Apps?" Duane Morris Alert, June 3, 2013
• "United States v. Caronia: A Brief Look at the Broader Implications for the Food Industry," FDLI Update, March/April 2013
• Co-author, "Overview of 2013 Amendments to HIPAA Privacy, Security, Breach Notification and Enforcement Rules," Duane Morris Alert, January 29, 2013
• Author, "New HIPAA Breach Notification Rule May Prove Costly for HIPAA-Covered Entities," Duane Morris Alert, January 25, 2013
• "Chapter 1040 - Ambulance Services," BNA's Health Care Compliance Guide, 2012 and 2013 editions
• Co-author, "CMS: Proposed Rule for States on Medicaid Fee-for-Service Rate-Setting Procedures," Duane Morris Alert, May 12, 2011
• Co-author, "New HIPAA and HITECH Regulations Are Coming," Duane Morris Alert, December 21, 2009
• Co-author, "How Hard Should It Be to Imprison Someone for Telling the Truth?" FDLI Update, September/October 2009
• Co-author, "Compliance with New HIPAA and FTC Health Breach Notification Rules: What Healthcare Entities and Businesses Need to Know," Duane Morris Alert, August 28, 2009
• Co-author, "The First Amendment and Off-Label Promotion: Why the Court in United States v. Caronia Got it Wrong," Health Care Law Monthly, April 2009
• Co-author, "The Debate Over Reference Checks: What to share about former employees," Modern Healthcare, June 2008

Selected Speaking Engagements

• Speaker, "FDA Regulation of Promotion & Advertising Social Media & Internet, California Healthcare Institute, June 25, 2013
• Presenter, "Violations and Enforcement," Food and Drug Law Institute's Conference on Introduction to Drug Law and Regulation: The Legal Framework for Drug Regulation, Washington, D.C., April 4, 2013
• Presenter, "Reimbursement for Subject Injuries in Clinical Trials How to Avoid an 'Adverse Event' to Your Business," FDAnews Webinar, February 20, 2013
• Presenter, "Introduction to Medical Device Law and Regulation: How the Government Regulates the Medical Device Industry," Washington D.C., March 12, 2012