Overview of Medical Devices and HIPAA Security Compliance
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1 Technology in Medicine Conference on Medical Device Security Overview of Medical Devices and HIPAA Security Compliance Wednesday, March 9, 2005 Stephen L. Grimes, FACCE Chair, Medical Device Security Workgroup Healthcare Information and Management Systems Society (HIMSS) Chair, HIPAA Task Force American College of Clinical Engineering (ACCE) Senior Consultant & Analyst Strategic Health Care Technology Associates
2 Medical Device Security: Is this just a HIPAA issue? NO!.. Even if HIPAA were thrown out, Medical Device Security is a necessity not just a regulation Medical device security particularly data integrity & data availability is critical to healthcare quality, timeliness, and cost- effectiveness Today, a reasonable standard of care cannot be maintained without an effective an Information Security Management Program in place that includes biomedical technology March 9, 2005 HIMSS / ACCE / ECRI ~ 2
3 HIPAA s s Security Rule Implications for Biomedical Devices & Systems
4 Security Risks to Healthcare Technology Make sure you are addressing more than the tip of the risk! Risks to Healthcare IT Systems Risks to Biomedical Devices & Systems The inventory of biomedical devices & systems in a typical hospital is times larger than the IT inventory March 9, 2005 HIMSS / ACCE / ECRI ~ 4
5 Significant Medical Device Industry Trends Medical devices and systems are being designed and operated as special purpose computers more features are being automated, increasing amounts of medical data are being collected, analyzed and stored in these devices There has been a rapidly growing integration and interconnection of disparate medical (and information) technology devices and systems where medical data is being increasingly exchanged March 9, 2005 HIMSS / ACCE / ECRI ~ 5
6 Information Technology Systems Mission Critical Activities, processing, etc., that are deemed vital to the organization's business success or existence. If a Mission Critical application fails, crashes, or is otherwise unavailable to the organization, it will have a significant negative impact upon the business. MISSION CRITICAL Examples of Mission Critical applications include accounts/billing, customer balances, ADT processes, JIT ordering, and delivery scheduling. March 9, 2005 HIMSS / ACCE / ECRI ~ 6
7 Biomedical Technology Systems Life Critical Devices, systems and processes that are deemed vital to the patient s s health and quality of care. If a Life Critical system fails or is otherwise compromised, it will have a significant negative impact on the patients health, quality of care or safety. LIFE CRITICAL Examples of Life Critical systems include physiologic monitoring, imaging, radiation therapy, and clinical laboratory systems. March 9, 2005 HIMSS / ACCE / ECRI ~ 7
8 HIPAA Security requires Risk Analysis: Risks Associated with IT vs Biomedical Systems IT Systems MISSION CRITICAL Medical Devices & Systems LIFE CRITICAL March 9, 2005 HIMSS / ACCE / ECRI ~ 8
9 HIPAA s s Security Rule Implications for Biomedical Technology Why is security an issue for biomedical technology? Because compromise in ephi can affect Integrity or Availability can result in improper diagnosis or therapy of patient resulting in harm (even death) because of delayed or inappropriate treatment Confidentiality can result in loss of patient privacy and, as a consequence, may result in financial loss to patient and/or provider organization March 9, 2005 HIMSS / ACCE / ECRI ~ 9
10 HIPAA s s Security Rule Implications for Biomedical Technology Standalone with ephi March 9, 2005 HIMSS / ACCE / ECRI ~ 10
11 HIPAA s s Security Rule Implications for Biomedical Technology Both Standalone and Networked Systems with ephi March 9, 2005 HIMSS / ACCE / ECRI ~ 11
12 HIPAA s s Security Rule Overview of Compliance Process
13 HIPAA s s Security Rule Compliance Overview Information Security Management (ISM) Program Risk Analysis & Management Plan (RAMP) March 9, 2005 HIMSS / ACCE / ECRI ~ 13
14 HIPAA s s Security Rule Compliance Overview Establish effective Info Security Management (ISM) program: 1) Assign security official & establish information security committee 2) Develop necessary policies as per security standards 3) Develop necessary procedures, physical/technical safeguards as per implementation specifications 4) Implement Policies/procedures, Business associate agreements, Educate workforce & Install/Configure security tools 5) Test implementation 6) Integrate security measures into organization-wide program March 9, 2005 HIMSS / ACCE / ECRI ~ 14 Increasing Levels of Program Effectiveness Policies Procedures Implementation Testing Integration GOAL: HIPAA Compliance & an Effective Info Security Program
15 HIPAA s s Security Rule Compliance Overview representatives of device users (i.e., clinical staff) Clinical Engineering Information Security Official Information Services / Information Technology Facilities Engineering Staff Education / Inservice Human Resources Information Security Committee Materials Management / Purchasing Quality Assurance Administration Core Members Compliance Officer Privacy Official Risk Management Ad Hoc Members slgrimes March 9, 2005 HIMSS / ACCE / ECRI ~ 15
16 HIPAA s s Security Rule Compliance Overview Establish Risk Analysis/Management Plan (RAMP): 1) Conduct inventory (identify sources of ephi) and survey current security practices & resources 2) Identify and Assess Security Risks 3) Establish Priorities 4) Determine Security Gap (i.e., need for additional safeguards) following best practices and Security Rule s Standards and Implementation Specifications 5) Formulate/Implement Plan for Risk Mitigation Process incorporating Risk-based Priorities 6) Test & Measure Effectiveness of Risk Mitigation Process (Improving as Necessary) March 9, 2005 HIMSS / ACCE / ECRI ~ 16
17 Compliance Overview Risk Analysis/Management 1) Conduct Inventory Identify biomedical devices & systems that maintain and/or transmit ephi For each affected device/system, determine: Types of ephi Who has access & who needs access Description of any connections with other devices Types of security measures currently employed New! HIMSS Manufacturers Disclosure Statement for Medical Device Security (MDS 2 ) Nov 8, 2004 March 9, 2005 HIMSS / ACCE / ECRI ~ 17
18 Compliance Overview Risk Analysis/Management 1) and Survey current security practices & resources to analyze existing processes Policies & procedures Training programs Tools & security measures March 9, 2005 HIMSS / ACCE / ECRI ~ 18
19 Keyboard Create/Input ephi Maintain ephi Hard Disk Component, Device, or System Transmit/Receive ephi Disk Scanning - bar code - magnetic - OCR Memory (e.g., RAM) INSERT THIS END 56K PCMCIA Tape Digital Memory Card Imaging - photo - medical image Biometrics Disk Tape Digital Memory Card INSERT THIS END 56K PCMCIA Optical disk, CD-ROM, DVD Wired Networks Private or Public, Leased or Dial- up lines, Internet Voice Recognition Optical disk, CD-ROM, DVD Wireless Networks March 9, 2005 HIMSS / ACCE / ECRI ~ 19
20 Compliance Overview Inventory of Devices/Systems Physiologic Monitor where ephi may consist of patient identifying information and the following data: ECG waveform Blood pressure Heart rate Temp O 2 Saturation Respiration Alarms March 9, 2005 HIMSS / ACCE / ECRI ~ 20
21 Compliance Overview Inventory of Devices/Systems Infusion pump where ephi may consist of patient identifying information and the following data: Flow Rate Volume delivered Alarms March 9, 2005 HIMSS / ACCE / ECRI ~ 21
22 Ventilator Compliance Overview Inventory of Devices/Systems where ephi may consist of patient identifying information and the following data: Flow Rate Volume Delivered Respiration (Breaths Per Minute) O 2 Saturation Alarms March 9, 2005 HIMSS / ACCE / ECRI ~ 22
23 Compliance Overview Inventory of Devices/Systems Laboratory analyzer where ephi may consist of patient identifying information and the following data : Blood related - Hemoglobin - Glucose - Gas - ph - Electrolyte Urine related - Albumin - Creatinine - Bilirubin March 9, 2005 HIMSS / ACCE / ECRI ~ 23
24 Compliance Overview Inventory of Devices/Systems MRI, CT Scanner, Diagnostic Ultrasound where ephi may consist of patient identifying information and the following data : Image March 9, 2005 HIMSS / ACCE / ECRI ~ 24
25 Confidentiality Availability Medical Device/System with electronic Protected Health Information High Medium Low Compliance Overview Risk Analysis/Management 2) Assess risk with respect to confidentiality, integrity, availability: Criticality Categorize level of risk/vulnerability (e.g., high, medium, low) to CIA Probability Categorize the likelihood of risk (e.g., frequent, occasional, rare) to CIA Composite Score for Criticality/Probability March 9, 2005 HIMSS / ACCE / ECRI ~ 25
26 Taking into account Criticality: Assess Risk associated with compromises to Integrity of ephi Central Station Patient Physiologic Monitor Clinician with Authorized Access Data Actual Maintained/ Transmitted Patient ID Heart Rate 60 bpm 35 bpm Blood Pressure 120/80 mmhg 90/50 mmhg Temp 98.6º F 89.6º F SpO2 92% 92% Integrity March 9, 2005 HIMSS / ACCE / ECRI ~ 26
27 Taking into account Criticality: Assess Risk associated with compromises to Availability of ephi Central Station Patient Physiologic Monitor Clinician with Authorized Access Data Actual Maintained/ Transmitted Patient ID XXXXX Heart Rate 60 bpm Blood Pressure XX bpm 120/80 mmhg XXX/XX mmhg Temp 98.6º F XX.Xº F SpO2 92% XX% Integrity Availability March 9, 2005 HIMSS / ACCE / ECRI ~ 27
28 Taking into account Criticality: Assess Risk associated with compromises to Confidentiality of ephi Central Station Patient Physiologic Monitor Unauthorized Access Clinician with Authorized Access Data Actual Maintained/ Transmitted Confidentiality Patient ID Availability Heart Rate 60 bpm 60 bpm Integrity Blood Pressure 120/80 mmhg 120/80 mmhg Temp 98.6º F 98.6º F SpO2 92% 92% March 9, 2005 HIMSS / ACCE / ECRI ~ 28
29 Assessing Criticality of Risk Associated with Biomedical Devices/Systems with ephi RISK LEVEL High Medium Potential degree to which health care would be adversely impacted by compromise of availability or integrity of ephi Serious impact to patient s health (including loss of life) due to: misdiagnosis, delayed diagnosis or improper, inadequate or delayed treatment Minor impact to patient s health due to: misdiagnosis, delayed diagnosis or improper, inadequate or delayed treatment Impact on Patient Potential degree to which privacy would be adversely impacted by compromise of confidentiality of ephi Could identify patient and their diagnosis Could identify patient and their health information (but from which a diagnosis could not be derived) Potential degree to which interests would be adversely impacted by compromise of confidentiality, availability or integrity of ephi Extremely grave damage to organization s interests Serious damage Impact on Organization Potential financial impact Major $1,000K Moderate $100K Low Minor Impact Could identify patient Minor damage Minor $10K Potential legal penalties Imprisonment and/or large fines Moderate Fines None Likely corrective measures required Legal Legal Administrative March 9, 2005 HIMSS / ACCE / ECRI ~ 29
30 Assessing Probability of Risks Associated with Biomedical Devices/Systems with ephi Frequent Likely to occur (e.g., once a month) Occasional Probably will occur (e.g., once a year) Rare Possible to occur (e.g., once every 5-10 years) March 9, 2005 HIMSS / ACCE / ECRI ~ 30
31 Assessing Criticality & Probability of Risks associated with Biomedical Devices/Systems with ephi Determining the Criticality/Probability Composite Score Rare Probability Occasional Frequent High Criticality Medium Low March 9, 2005 HIMSS / ACCE / ECRI ~ 31
32 Compliance Overview Risk Analysis/Management 3) Establish priorities Use Criticality/Probability composite score to prioritize risk mitigation efforts Conduct mitigation process giving priority to devices/systems with highest scores (i.e., devices/systems that represent the most significant risks) March 9, 2005 HIMSS / ACCE / ECRI ~ 32
33 Compliance Overview Risk Analysis/Management 4) Determine security gap Determine what measures are necessary to safeguard data Compare list of necessary measures with existing measures identified during biomedical device/system inventory process Prepare gap analysis for devices/systems detailing additional security measures necessary to mitigate recognized risks (addressing devices/systems according to priority) March 9, 2005 HIMSS / ACCE / ECRI ~ 33
34 Compliance Overview Risk Analysis/Management 5) Formulate & implement mitigation plan Formulate written mitigation plan incorporating additional security measures required (i.e., policies, procedures, technical & physical safeguards) priority assessment, and schedule for implementation Implement plan & document process March 9, 2005 HIMSS / ACCE / ECRI ~ 34
35 Compliance Overview Risk Analysis/Management 6) Monitor process Establish on-going monitoring system (including a security incident reporting system) to insure mitigation efforts are effective Document results of regular audits of security processes March 9, 2005 HIMSS / ACCE / ECRI ~ 35
36 Compliance Overview Risk Analysis/Management Prepare a Risk Mitigation Worksheet 1 Identify ephi 2 Identify & Assess Risks 3 Establish Priorities 4 Determine Gap 5 Formulate & Implement Plan 6 Test & Measure Effectiveness of Plan March 9, 2005 HIMSS / ACCE / ECRI ~ 36
37 HIPAA s s Security Rule Overview of Compliance Process March 9, 2005 HIMSS / ACCE / ECRI ~ 37
38 Questions? Stephen L. Grimes, FACCE Strategic Health Care Technology Associates Health Information and Management Systems Society American College of Clinical Engineering (ACCE) ECRI
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