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Regulatory Affairs / Information Technology - The Law Office of Susan F. Zinder, PLLC

Regulatory Affairs / Information Technology

Client: Community-based hospital

Situation: Client separating from larger health care system

  • Three hospital health care system disaffiliating
  • Client was smallest of three entities, disproportionately reliant on parent organization
  • Constituent organizations built and maintained joint data center and technology platform, which needed to be divided to enable disaffiliation
  • Parent organization insisted upon payment of outstanding inter-company indebtedness
  • All negotiations made more complex because some negotiations were among former health system entities, and some were between the former health system and its chosen outsource vendor

Legal issues:

  • Former parent effectively threatens ongoing viability of client’s IT infrastructure and potentially its ability to provide patient care
  • Client need to negotiate division of assets and phase out of existing IT infrastructure and support from former parent organization
  • Need to negotiate with vendor to outsource data center operations
  • Negotiations were made more complex because some negotiations were adversarial among the disaffiliating partners
  • Client needed to independently replace hardware and software platform, including
  • license clinical, financial, radiology, laboratory and departmental systems
  • Need to negotiate with parent transitional arrangements pending cut over to negotiated systems pending go-live of its new IT infrastructure
  • System transition could not impair patient care or ability of client to bill and collect for its services

Legal solutions/strategies:

  • Collaborate with health system team on negotiation of replacement outsourced data center meeting all IT needs
  • Negotiate with outsource vendor for specific client needs
  • Negotiate with software providers for clinical and financial IT licenses on an urgent basis to implement new platform
  • Negotiate with former parent organization for temporary continuance of access to former data and support platform during transition to new platform

Outcome:

Successful implementation of new IT infrastructure

 


 

Client: IT Company in Mobile Patient Communication Space

Situation: Client developing new business technologies in healthcare

  • Technology application was new
  • Regulatory guidance was unclear
  • Previous counsel advised client to abandon business plan

Legal Issues:

  • Client’s proposed business model involved providers sending text messages to patients
  • Federal and state regulations — including HIPAA — affected viability of client’s business model
  • Legal structures needed to permit further development and deployment of business model within context of rapidly-developing regulatory scheme

Legal Solution:

  • Research myriad federal regulations, including HIPAA and TCPA
  • Research state regulations regarding health care information, information security and electronic signatures
  • Develop legal analysis supporting client’s business model
  • Create with client unique consenting and workflow processes enabling client’s business model

Outcome:

  • Client launched real time patient engagement platform with robust back-end analytic tools
  • Client company was acquired by larger entity approximately 4 years after launch
 


 

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