CyberSecurity and Privacy

Healthcare IT professionals should take the time to review Carestream Health's product security documentation, these documents provide a high-level overview of the security configurations related to the operating systems for our products. Additional documentation assists customers in their purchasing decision related to the requirements and product capability specified by the Health Insurance Portability and Accountability Act (HIPAA) Security Rule.

Many International security regulations require healthcare providers and payers to protect patient information from improper access, modification, and catastrophe loss. Carestream Health is committed to providing industry leading security capabilities in our products and service delivery

Product Security

Healthcare IT professionals should take the time to review Carestream Health's product security documentation, these documents provide a high-level overview of the security configurations related to the operating systems for our products. Additional documentation assists customers in their purchasing decision related to the requirements and product capability specified by the Health Insurance Portability and Accountability Act (HIPAA) Security Rule.
Many International security regulations require healthcare providers and payers to protect patient information from improper access, modification, and catastrophe loss. Carestream Health is committed to providing industry leading security capabilities in our products and service delivery.

Manufacturers Disclosure Statement for Medical Device Security (MDS²)
The Manufacturers Disclosure Statement for Medical Device Security provides customers with HIPAA-related security information about their products and services. The MDS ² is endorsed by the American College of Clinical Engineering (ACCE), ECRI (formerly the Emergency Care Research Institute), Healthcare Information and Management Systems Society (HIMSS) and the National Electrical Manufacturers Association (NEMA).

Carestream Health is an active member of the Medical Device Security Workgroup and supports the use of the MDS ². For greater details, go to Manufacturer Disclosure Statement for Medical Device Security. The following links contain product security information outlined in the MDS ².

Our current-generation digital medical products carry the CARESTREAM brand, except in a few instances where we will continue to license the KODAK brand. for use on selected products. While we no longer market previous-generation products carrying the KODAK brand, we will continue to provide technical/support information -- like that contained below -- to customers who previously purchased these products.

Digital Capture Systems 

• Carestream MDS² DR SW V5.7 (PDF)
• Carestream MDS² DR SW V5.6 (PDF)
• CARESTREAM ImageSuite 4.0 MDS² (PDF)
• Digital Capture Systems Carestream MDS² for DR SW V5.3 (PDF)
• Carestream MDS ²  for CR SW V5.7 (PDF)
• Carestream MDS ²  for CR SW V5.2 (PDF)
• Carestream MDS ² for Classic, Elite, 975, 950, 850, 825 CR SW V5.1 (PDF)
• Point-of-Care CR 120/140/260 System (PDF)
• Point-of-Care CR ITX560 System (PDF)
• Carestream MDS ² for DRX-Evolution (PDF)
• Carestream MDS² for DRX-1 Detector System (PDF)
• Carestream MDS ² for DRX-1 Mobile Retrofit Kit (PDF)
• Carestream MDS ² for all DR-DRX - Software Version 5.5 (PDF)
• Carestream MDS ² form for DRX-Excel V1.13 (PDF)
• Carestream MDS ² for DRX-Excel, DRX-Excel Plus V1.09 (PDF)

Legacy Digital Capture System Statements

• Carestream MDS² for CR Software V4.6 (PDF)
• MDS ² Form for CR 500-975 and ROP SW v4.5 (PDF)
• MDS ² Form for 500-850-950 and ROP SW v4.3 (PDF)
• Point-of-Care CR 360-260-140-120 System SW v3.0 (PDF)
• MSD² for DR9500 SW v4.5 (PDF)
• MSD² for DR7500 SW v4.0 (PDF)
• MDS² for DR 3000, DR 3500 SW 3.0.x, 3.5.x (PDF)
• MDS² Form for DR 5000-9000 SW v2.0 (PDF)

Other

• MDS ² Form for CARESTREAM MyVue Center Self-Service Kiosk (PDF)

Ultrasound

• MDS² for Touch Prime and Touch Prime XE Form (PDF) 

Cone Beam CT (CBCT)

• OnSight 3D Extremity ImageView V1.1 (PDF)
• OnSight 3D Extremity ImageView V1 (PDF)

Digital Output Systems

• HG MDS ² Form for DRYVIEW 6950(PDF)
• HG MDS ² Form for DRYVIEW 5700 (PDF)
• HG MDS ² Form for DRYVIEW 5950 (PDF)
• HG MDS ² Form for 5800 (PDF)
• HG MDS ² Form for 6800 (PDF)
• HG MDS ² Form for DRYVIEW 6850 (PDF)
• HG MDS ² 8300 8610 (PDF)
• HG MDS ² Form for 8100 8200 (PDF)
• HG MDS ² Form for 8150 (PDF)
• HG MDS ² Form for 8500 8700 (PDF)
• HG MDS ² Form for 8800 (PDF)
• HG MDS ² Form for 8900 (PDF)
• HG MDS ² Form for PACS Link 25 Print Server r3 (PDF)
• HG MDS ² Form for PACS Link MIM 100 r3 (PDF)
• HG MDS ² Form for PACS Link MIM 200 r3 (PDF)
• HG MDS ² Form for CMI1000 (PDF)

Healthcare Information Solutions

• CARESTREAM PACS V11.0 MDS ²

To our customers, Carestream Health provides documentation below of our product security assessments.

Digital Capture Systems

• Capture Link Server V1.00 (PDF)
• CR V4.31 (PDF)
• DR V2.0 (PDF)
• CR Systems with Software V4.1 (PDF) 
• DIRECTVIEW CR System Software Version 5.1 (PDF)
• CR Systems, Software V3.x.x, V2.2.1 and DR Systems, Software V1.x.x (PDF)

Digital Output Systems (PDF)

• Medical Image Manager (MIM) V6.1.1 (PDF)
• DRYVIEW 5850 Imager (PDF)
• DRYVIEW 8150 Imager (PDF)
• DRYVIEW 8900 Imager (PDF)
• Color Medical Imager 1000 software v1.1 (PDF)

General Data Protection Regulation "GDPR"

There is a new European Privacy initiative--the General Data Protection Regulation "GDPR". This initiative takes effect on May 25, 2018. Please read closely the Annex which is incorporated into the agreement your company may have with Carestream.

• Carestream GDPR Annex Compliance with the EU General Data Protection Regulation

HIPAA Overview

HIPAA Compliance

The Health Insurance Portability and Accountability Act (HIPAA) was signed into law August 21, 1996. This legislation affects nearly everyone involved in healthcare from providers to healthcare information systems vendors. HIPAA contains provisions for:

• Portability of insurance coverage as employees move from one employer to another.
• Protection of patient-identifiable data from inappropriate disclosure and the type of information that must be protected and the circumstances.
• Defined policies, analyses, practices, and mechanisms that must be conducted to ensure the privacy of “protected health information” (PHI) is maintained.
• Government-mandated standards for electronic transactions, code sets and identifiers.

Related Resources:

• Carestream HIPAA Overview (PDF)
• Carestream Dental HIPAA Compliance Information

Carestream HIPAA Business Associate Agreements

Carestream business associates must comply with HIPAA regulations. Please contact your local sales representative or contract manager for information about the provisions and terms in their agreement.

Correspondence should be mailed to:

Carestream Health, Inc.
Attn: US&C Contract Management
150 Verona Street
Rochester, NY 14608

Related Documents: 

• Carestream HIPAA Compliance Business Associates Agreement (PDF)