Practice Areas & Industries: Duane Morris LLP


Healthcare Information Technology Return to Practice Areas & Industries

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Practice/Industry Group Overview

As a law firm with one of the largest healthcare practice groups in the United States, Duane Morris attorneys are witnessing the increasing influence and complexity of information technology in the delivery of healthcare by direct care providers (such as hospitals, physicians, skilled nursing facilities, pharmacies, device makers and laboratories) as well as ancillary entities (such as billing companies, vendors, insurance companies and investment funds, that provide services or financing to healthcare providers). These entities face significant challenges in protecting their data and implementing, managing, maintaining and protecting the various components of the systems they employ to do business and remain up-to-date on the laws regarding the protection of protected health information (PHI), price data, quality data and other sensitive information. The successful integration and use of technology can streamline operational systems, increase efficiencies, reduce costs and improve care. To ensure successful outcomes, however, healthcare companies must be vigilant. Technology privacy and security problems can and will occur, and the most successful companies will be those that optimally minimize their risks.

Duane Morris offers clients the joint services of its attorneys knowledgeable in both the healthcare and IT industries. Duane Morris' cadre of experienced healthcare attorneys counsel leading organizations on regulatory, business transactions and litigation matters. Duane Morris' industry-specific IT attorneys are involved in the technology industry on a daily basis and have extensive, in-depth experience with information technology agreements and data protection issues. From crafting RFPs for software and conducting HIPAA privacy and security reviews, to drafting implementation strategies and identifying security vulnerabilities, the firm's team of healthcare and IT attorneys work together to provide clients with sound legal advice to address the far-reaching implications of technology in each of their businesses and to anticipate and minimize risks related to the health system's, or ancillary business', information technology and health information.

Our healthcare/IT counseling work includes the following:

  • IT Systems and Procurement - Assisting clients in the procurement of IT systems and related vendor services. In advising clients in this area, we craft RFIs and RFPs, devise implementation strategies, identify risks and ensure that software development and implementation contracts are in sync with our clients' needs.
  • Licensing and Negotiations - Advising clients on licensing agreements, joint ventures, contract negotiations and other business legal issues related to technology acquisition and implementation, including advising on contracts with software vendors, managed services providers, outsourcing and hosting companies, payers, healthcare clearinghouses, third-party administrators and pharmacy management companies. Our IT attorneys have reviewed or negotiated software license agreements and hardware procurement contracts with more than 300 different software and hardware vendors, including many of the top vendors in the healthcare industry.
  • E-Commerce - Advising clients with issues regarding web-based applications such as e-payment systems, including setting up website terms of use and privacy policies and advising generally on website structure, linking issues and other content-related issues and concerns.
  • HIPAA/Privacy Compliance - Ensuring that electronic medical records (EMR), or electronic health records (EHR) systems and other IT systems (e.g., electronic prescribing, virtual medicine) comply with applicable privacy laws (e.g., HIPAA, Gramm-Leach-Bliley Act, Children's Online Privacy Act) and responding to potential broad-based and individual compliance concerns, particularly as HIPAA enforcement is intensified through corrective action plans, resolution agreements and financial penalties. We also counsel clients on e-records, data mining and analysis, records retention, maintenance and conversion.
  • IT and Healthcare Fraud and Abuse and Self-Referral - Counseling clients regarding the provision of hardware, software or other information technology to physicians, other healthcare professionals, pharmacists and pharmacies to ensure compliance with the federal anti-kickback and physician self-referral statutes and regulations.
  • Security Breaches and Compliance - Handling security breaches and inadvertent loss of data. Given the sensitivity of healthcare information, our attorneys conduct technology security audits as well as develop security policies and procedures and compliance programs.
  • Foreign Privacy Laws - Advising on procurement, project development, licensing, risk management, compliance, privacy and other legal issues related to projects that are subject to the laws of foreign jurisdictions, such as Canada's Personal Information Protection and Electronic Documents Act (PIPEDA).
  • Corporate Structure and Finance - Advising on corporate structure and finance issues and identifying and negotiating joint venture arrangements with intellectual property issues for start-up companies or strategic alliances regarding new technology in the healthcare industry.
  • Patient Safety Procedures and Reporting - Advising on establishing patient safety organizations and reporting procedures for providers under the Patient Safety and Quality Improvement Act.
  • FTC Red Flags Rules on Identify Theft Protection Programs - Assisting hospitals and other providers with developing and implementing identity theft protection programs in compliance with the Federal Trade Commission's "Red Flags" rules.

Many healthcare providers are only beginning to understand the scope of their healthcare IT legal needs. To help gauge how Duane Morris can help, please consider the following:

  • Are your IT personnel getting value out of the RFP process by being able to ask the right risk assessment questions to vendors that are participating in the process?
  • After spending millions of dollars on a specific application, do the software application and maintenance agreements include contractual obligations on the part of the vendor for the vendor or a third party to support the purchased software for an adequate period of time without your organization having to incur additional costs for unexpected upgrade requirements?
  • Do your agreements sufficiently hold the third-party vendor responsible for the type of damages your organization needs to recover should a software implementation fail or a security leak of personal or protected health information occur?
  • Has your organization developed a clear policy for employee and third-party vendor use of technology so that privacy and security breaches and inadvertent loss of sensitive data do not occur?

Duane Morris can assist you with these and any other of your IT needs.

Past Seminar Materials
  Duane Morris Special Counsel Michael E. Clark to Present at the 2015 Physicians Legal Issues Conference, Chicago, IL, June 10, 2015
Simplifying the Complexities of Compliance, Wheeling, IL, June 3, 2015
Duane Morris Partner Lisa Clark will be a Panelist at the Drexel University Cybersecurity Institute Symposium Healthcare Data Security Part II, Philadelphia, February 25, 2015
Duane Morris Partner Mark Silberman to Present at AHLA's Long Term Care and the Law Conference, New Orleans, February 24, 2015
Articles Authored by Lawyers at this office:

CMS Updates 5 Star Ratings System for Nursing Homes with New Measures
Ari J. Markenson, April 07, 2015
As of February 20, 2015, the Centers for Medicare & Medicaid Services (CMS) has revised its 5 Star Rating System for nursing homes. The changes to the system involve adding two new nursing home quality measures for antipsychotic use into the Quality Measure Rating, Increasing the number of...

Lawyer in Vietnam Oliver Massmann Pharmaceutical Market
Oliver Massmann, March 30, 2015
Vietnam’s healthcare system is currently in general on the move due to the economic growth and the rapid development.

OIG - Medicare Hospices Have Financial Incentives to Provide Care in Assisted Living Facilities
Ari J. Markenson, March 30, 2015
On January 14, 2015, the U.S. DHHS Inspector General’s Office (the “OIG”) released a report (OEI-02-14-00070) entitled “Medicare Hospices Have Financial Incentives to Provide Care in Assisted Living Facilities.”

CMS Advises That Payment Codes on Home Health Claims Will Be Matched Against OASIS
Ari J. Markenson, March 25, 2015
CMS recently issued Transmittal SE1504 entitled “Payment Codes on Home Health Claims Will Be Matched Against Patient Assessments”.

Civil RICO Actions on the Rise to Combat Healthcare Insurance Fraud
James J. Ferrelli, March 25, 2015
Over the past several years, insurance carriers have aggressively pursued civil suits against doctors and other medical providers in an effort to fight healthcare insurance fraud. Besides theories of liability based upon common law claims such as fraud and unjust enrichment, insurers have more...

Consultants’ Communications Privileged from Discovery
Philip H. Lebowitz, March 25, 2015
In healthcare, companies often hire consultants to review billing and coding, privacy and security and a host of other technical issues that regular staff does not have the time or expertise to pursue. A recent discovery ruling in federal court in the Eastern District of Pennsylvania holds that...

HHS Moves to Limit In-Office Ancillary Services Exception
Matthew C. Jones, March 19, 2015
The Department of Health and Human Services (“HHS”) is once again targeting the In-Office Ancillary Services Exception (“IOASE”) to the federal Stark Law, in an attempt to produce cost savings in the U.S. healthcare system. The IOASE provides a limited exception to the Stark...

Health System Integration and Antitrust Laws on Collision Course
Philip H. Lebowitz, March 18, 2015
Health systems attempting to fulfill the mandate of integrating hospitals and physicians may find themselves accused of going too far. Although the Affordable Care Act, shared savings, gainsharing and other alternative payment methodologies have made integration of physicians, hospitals and other...

New Jersey State Bar Committee to Review RPC 1.2(d) and Issues Pertaining to Medical Marijuana
James J. Ferrelli, March 18, 2015
The New Jersey State Bar Association (“NJSBA”) has established an ad hoc committee to review the ethical issues raised under New Jersey Rule of Professional Conduct 1.2(d) (which prohibits a lawyer from counseling or assisting a client in conduct that the lawyer knows is illegal or...

Virtual Credit Card Payments
Patricia S. Hofstra, March 18, 2015
On January 30, 2015, several healthcare organizations sent a group letter to CMS protesting the use of virtual credit cards by health plans to pay providers. In a virtual credit card payment (a nonstandard type of electronic funds transfer EFT), a health plan or its payment vendor issues single-use...

ACOs are More Important Than Ever for LTC Facilities
Amy E. McCracken, March 13, 2015
On January 26, 2015, the United States Department of Health & Human Services (HHS) announced its timeline for shifting Medicare reimbursements from volume-based criteria to value-based criteria. HHS has adopted a framework that categorizes health care payments according to how providers receive...

Antipsychotic Drug Use Can Lower Nursing Home's Five-Star Rating
Amy E. McCracken, March 13, 2015
The Centers for Medicare & Medicaid Services (CMS) is continuing its efforts to reduce the national prevalence of antipsychotic drug use in long-stay nursing home residents. Its initial goal of a 15.1% reduction in antipsychotic drug use was met, so CMS now seeks to reduce antipsychotic drugs...

Fees and Costs Awarded to False Claims Act Defendant
Seth A. Goldberg, March 13, 2015
A recent decision in the U.S. District Court for the Southern District of New York provides fair warning to qui tam relators who assert erroneous claims under the False Claims Act ("FCA") that they could be hit with legal fees and expenses pursuant to 31 U.S.C. § 3730, which permits...

Health Care Workers May Think Twice Before Becoming a Relator
Amy E. McCracken, March 13, 2015
The Federal False Claims Act (and many similar state false claims acts) allow an individual-called a "relator"-to file a lawsuit on behalf of the United States Government. If successful, the relator stands to collect a portion of the amount collected. Since the False Claims Act provides...

Mayo Lawsuit Against Former Exec Raises Numerous Health Care and Business Litigation Issues
Elinor H. Murarova, March 13, 2015
A recent settlement between Mayo Collaborative Services d/b/a Mayo Medical Laboratories ("MML") and Mayo Clinic (together with MML, "Mayo") and a former Mayo executive, Dr. Franklin Cockerill, reveals the potential legal issues that may arise when health care executives seek new...

New CMS Payment Policy Will Negatively impact Healthcare Investors
C. Mitchell Goldman, March 13, 2015
I have been concerned about the difficulty of projecting revenue and determining valuations for new and existing healthcare companies based on risk based reimbursement models. My fears have not been allayed. Rather, they have been confirmed.

Real Estate Tax Exemption Issue Muddied Again
Philip H. Lebowitz, March 13, 2015
On December 23, 2014, the Commonwealth Court of Pennsylvania logged another frustrating mile down the confused and confusing road of property tax exemption for purely public charities. In Fayette Resources, Inc. v. Fayette County Board of Assessment Appeals, the Court overturned a lower court...

Top Three Problems with Text Messaging in Health Care Settings
Amy E. McCracken, March 13, 2015
1. Since most text messaging is not a secure form of communication, it raises HIPAA concerns if any protected health information is included in the text message. There is the possibility of a data breach in the transmission of the text message, as well as in the event of a lost or stolen phone.

FDA Issues Guidance on Registration, Fees and Reporting Requirements for Drug Compounding Outsourcing Facilities
, February 26, 2015
On November 21, 2014, the U.S. Food and Drug Administration (FDA) announced the release of three new guidance documents related to drug compounding outsourcing facilities. These documents include:

7th Circuit Clarifies FCA Fraud Standard
Philip H. Lebowitz, January 23, 2015
In an opinion openly skeptical of a relator’s knowledge, the 7th Circuit Court of Appeals recently affirmed the dismissal of False Claims Act claims against a Chicago pharmacy brought by a former employee of the pharmacy. The principal claims in the case, nadyor v. Ukrainian Village Pharmacy,...

CMS Bringing Star Ratings to Home Health
Ari J. Markenson, January 23, 2015
The Centers for Medicare and Medicaid Services (“CMS”) issued a fact sheet on December 11th, 2014, discussing its intention to issue star ratings for Medicare certified home health agencies. The star ratings would be live in 2015.

Clinical Trial Sponsors Can Be Liable For Inadequate Consent Forms
Philip H. Lebowitz, January 23, 2015
Physicians acting as investigators for a clinical trial testing a new therapy are required to present to each patient or study subject a consent form, indicating that the patient understands the risks, benefits and alternatives of participating in the trial and voluntarily elects to do so. Federal...

The IMPACT ACT of 2014 - New Enforcement and Oversight for Hospice Providers
Ari J. Markenson, January 23, 2015
The IMPACT Act of 2014 (“IMPACT”) was signed into law on October 6, 2014. It includes two significant enforcement and oversight changes for Medicare hospice providers among other post-acute care policy changes.

OIG 2015 Work Plan - Hospice
Ari J. Markenson, January 22, 2015
Recently, the Department of Health and Human Services Office of the Inspector General (the OIG) released its work plan for 2015. The work plan provides stakeholders with a road map to the OIG’s activities in the coming year as they relate to its enforcement priorities and issues it will...

OIG 2015 Work Plan - Home Health
Ari J. Markenson, January 02, 2015
Recently, the Department of Health and Human Services Office of the Inspector General (the OIG) released its work plan for 2015. The work plan provides stakeholders with a road map to the OIG’s activities in the coming year as they relate to its enforcement priorities and issues it will...

Responding to Subpoena for Medical Records May Create Liability for Healthcare Providers Under State Law Negligence Claims
Seth A. Goldberg,Philip H. Lebowitz, December 10, 2014
Healthcare providers receiving a subpoena for patient medical records may want to think twice before complying with the subpoena and producing the records. A recent Connecticut case, Byrne v. Avery Center for Obstetrics and Gynecology, P.C. ("Byrne"), arose when the defendant gynecology...

CMS Extends Period of Exemption for Hospices Affected by Nursing Shortage
Ari J. Markenson, November 17, 2014
On October 3, 2014, CMS issued S&C: 12-43-Hospice entitled “Impact of Nursing Shortage on Hospice Care”.

FDA's Final Guidance on Determination of Five-Year NCE Exclusivity for Certain Fixed-Combination Drug Products Under Federal FDCA
Carolyn A. Alenci,Frederick R. Ball, November 17, 2014
The U.S. Food and Drug Administration (FDA) recently published its final Guidance for Industry detailing circumstances under which a fixed-combination drug product (FCD) may be entitled to five-year new chemical entity (NCE) exclusivity.

OIG 2015 Work Plan - Skilled Nursing Facilities
Ari J. Markenson, November 17, 2014
Recently, the Department of Health and Human Services Office of the Inspector General (the OIG) released its work plan for 2015. The work plan provides stakeholders with a road map to the OIG’s activities in the coming year as they relate to its enforcement priorities and issues it will...