David M. Mack

Partner

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David Mack practices exclusively in the health care and life sciences space.  David is a partner in the Health Law Practice Group and Chair of the Life Sciences and Medical Products Team. David has extensive experience representing life sciences and medical products companies, hospitals, health care facilities and health care providers on a broad range of business and regulatory issues including corporate governance; corporate and regulatory compliance; reimbursement; fraud and abuse; government and internal investigations; corporate organization; mergers and acquisitions; joint ventures, affiliations, collaborations and restructurings; contracting; tax exemption; licensure, accreditation and other approvals; research and development; protection of medical information; risk management and medical ethics issues.

David has a background in biology and has performed laboratory research at a leading university and worked as a research associate and project manager for a national clinical research organization. He has also volunteered as an emergency medical technician.  David interned with the legal department of an academic medical center and with the Public Health Committee of the Connecticut General Assembly and the Office of the Attorney General, Health and Human Services Division. David leverages his strong background in health care, policy and scientific research with his legal expertise to create a strong foundation for his Health Care and Life Sciences practices.

David frequently lectures on topics of interest to the health care and life sciences industry. Topics include corporate organization and governance, commercializing proprietary products, clinical research, responding to government investigations, Medicare and Medicaid audits, privacy and security of health information, health care fraud and abuse, issues involving electronic health records and health information exchanges, commitment and consent, and HIPAA.

In addition to responding to the day-to-day legal matters presented by hospitals, health care facilities, health care providers and bioscience companies, David and his team work on major projects for sophisticated clients regionally and nationally. To see some of these recent projects please click on the “experience” link above.

Distinctions

  • AV Peer Review Rated, Martindale-Hubbell
  • Chambers USA, America's Leading Lawyers: Healthcare; 2012-2013
  • Listed as a Connecticut Super Lawyer: Health Care; 2012
  • Listed as a Connecticut Super Lawyer Rising Star®: Health Care; 2009-2010
  • 40 Under Forty, Hartford Business Journal; 2008
  • New Leader of the Law, Connecticut Law Tribune; 2005
  • Two-time winner of the Joseph M. Healey Connecticut Health Lawyers Association's writing competition

Teaching Positions

  • Assistant Adjunct Professor at the University of Connecticut in the Department of Community Medicine, where he lectures on medical-legal issues and ethics.

Professional Affiliations

  • American Bar Association: Chair of the Health Law and Life Sciences Committee of the Business Law Section
  • Connecticut Bar Association: Member of Executive Committee and Immediate Past Chair of the Health Law Section
  • Healthcare Financial Management Association (HFMA): Member of the Connecticut Program Committee
  • American Health Lawyers Association
  • American Hospital Association
  • Connecticut Public Health Association Foundation, Immediate Past President
  • Connecticut Public Health Association, Past President 
  • Connecticut United for Research Excellence, Inc. (CURE): Director
  • Department of Community Medicine and Health Care, University of Connecticut School of Medicine, Assistant Adjunct Professor
  • North Central District Health Department, Director
  • Connecticut Health Council

General Counsel - AlloSource

Shipman & Goodwin is outside general counsel to AlloSource, one of the largest and most respected tissue banks in the United States.  We provide legal services relating to: research and development of human cell and tissue-based products; recovery, processing, distribution, collaboration and license agreements; joint ventures and acquisitions; and general corporate compliance and governance. 

Reorganized Health System

Restructured corporate governance of health system and its affiliates, including physician, home health and long term care providers, so that the system is better positioned to face the issues of health care reform. Restructuring involved collaboration between a hospital and its medical staff to draft and approve new medical staff bylaws and policies to facilitate the provision of high quality, efficient care through a cooperative and fair process.

Publications

May 22, 2013  Lessons Learned From "U.S. ex rel., Drakeford v. Tuomey Healthcare System, Inc."
May 16, 2013  Certificate of Need Regulations Finalized and Released
February 28, 2013  CMS Issues Physician Payments Sunshine Act Final Rule
February 12, 2013  HIPAA Final Rule
January 3, 2013  HHS Announces Mobile Device Security Initiative
October 23, 2012  DSS Releases Proposed Provider Audit Regulations
September 21, 2012  U.S. Department of Justice Announces $16.5 Million Settlement with HCA, Inc. for False Claims Act and Stark Law Claims
August 2, 2012  Breaches of Personal Information Must Now Be Reported to the Attorney General
June 28, 2012  Health Law Practice Group Discusses Supreme Court's Ruling on the Patient Protection and Affordable Care Act
June 26, 2012  Health Law 2012 Legislative Update
June 11, 2012  FDA Releases Guidance on Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices
June 6, 2012  DSS Publishes Final Regulations on Reimbursement of Medical Foundations
May 17, 2012  CMS Releases Final Rule on PPACA Program Integrity Provisions
May 2, 2012  FDA and HHS Rules on Disclosure of Conflicts of Interest in Research
February 16, 2012  OIG Alerts Physicians to Exercise Caution When Reassigning Medicare Payments
February 16, 2012  HHS Announces Strong Start Initiative to Increase Healthy Deliveries and Reduce Preterm Births
January 19, 2012  CMS Releases Proposed Reporting Requirements
January 11, 2012  CMS Publishes Guidance on Medicaid RAC Program
November 22, 2011  DSS Releases Proposed Medical Foundation Regulations
November 17, 2011  OCR Begins Pilot Phase of HIPAA Privacy and Security Audit Program
November 3, 2011  FINAL RULE: Medicare Program--Changes to the Ambulatory Surgical Centers Patient Rights Conditions for Coverage
October 19, 2011  FDA and CMS Announce Pilot Program for Parallel Review of Medical Devices
September 28, 2011  Are You Aware of and Affected by These DPH Scope of Practice Requests?
August 16, 2011  Health Law 2011 Legislative Update
August 8, 2011  Sample Workplace Violence Prevention Policy to Comply With New Connecticut Legislation
August 4, 2011  CMS Proposes to Extend the 3-Day DRG Window to Hospital-Owned and Hospital-Operated Physician Practices
July 11, 2011  OCR Proposes Significant Revisions to HIPAA Rules on Accounting of Disclosures
June 10, 2011  CMS Clarifies that State Medicaid Agencies Have Ability to Protect Same-Sex Couples
June 3, 2011  CMS Issues Final Rule on Denial of Medicaid Payments for "Hospital Acquired Conditions"
June 3, 2011  CMS Announces Proposed Changes to eRX Incentive Program
May 16, 2011  Be Wary Of Medical Companies Bearing Gifts
May 5, 2011  CMS Releases Final Rule on Telemedicine Credentialing and Privileging
April 1, 2011  Proposed Rules Regarding Accountable Care Organizations Issued
February 28, 2011  First-Ever Civil Monetary Penalties Imposed for Violation of the HIPAA Privacy Rule
January 14, 2011  Summary of Proposed Certificate of Need Regulations
December 28, 2010  Sample Hospital Patient Visitation Policy To Comply With New CMS Rules For Participation
November 15, 2010  Recent Settlement Demonstrates Pitfalls of Rewarding Physicians with Access to Hospital Facilities
September 21, 2010  The Medicare and Medicaid EHR Incentive Programs: What You Need to Know.
August 13, 2010  June 2010 Connecticut Health Law Legislative Update
August 10, 2010  HHS Announces Proposed HIPAA Rules
July 19, 2010  Health Care Reform Impact On The Biotechnology, Pharmaceutical and Medical Device Industries
May 21, 2010  Summary of PPACA Grants, Demonstration Projects and Other Funding Opportunities
April 28, 2010  Health Care Reform: Compliance Implications
December 8, 2009  Recent Modifications to HIPAA's Breach Notification and Enforcement Rules
October 28, 2009  Recent Law Modifies Connecticut HIV Testing Consent Requirements
August 14, 2009  Recent Law Establishes Medical Foundation Option for Hospitals and Health Systems
June 17, 2009  Recent Law Modifies Office of Health Care Access Certificate of Need Statutes
May 1, 2009  CMS Issues Guidance on EMTALA Regulations
March 27, 2009  Self-Disclosure Protocol No Longer Applicable to Stark Violations
March 2, 2009  Stimulus Package Significantly Expands HIPAA Requirements
July 15, 2008  HIPAA Security Alert - Executive Guidance

Practice Areas

Industries & Featured Services

Education

  • University of Connecticut School of Law, J.D., with honors
  • University of Connecticut, , M.P.H.,
    health law and ethics
  • Northeastern University, B.S., biology,
    magna cum laude

Bar Admissions

  • Connecticut
  • Massachusetts
  • Colorado
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