take on the role of a compliance consultant who has been hired to create a plan that will assist an institution in meeting its professional or governmental compliance standards.
This compliance plan will be based on the scenario you chose and researched in Week 2 Download scenario you chose and researched in Week 2. Include the following information in your compliance plan.
Carefully review the standards for the option you chose. Identify the specific compliance requirements within the standards, and briefly discuss the business reasons for implementing the standards chosen.
Explain the type of network design that would best meet the standards identified. Revise your network diagram from Week 2, using Visio within your lab environment. This diagram must be copied into your plan document as an image. (The Visio diagram may be included in your assignment by means of a screenshot pasted into your document prior to submission. Assistance with capturing a screenshot of your Visio may be found at Take-a-screenshot.orgLinks to an external site..) Describe how you would recommend segmenting the network in order to best meet compliance standards, providing a rationale for your suggestions and supporting your statements with your research.
Examine the firewall types necessary to ensure the security of the individual network segments within your institutional setting. Create a plan for the implementation of firewalls within each partition of the network.
Analyze the potential uses of intrusion detection systems (IDSs) within each network partition and recommend the placement of IDS within the partitions based on the standards for your institution. Evaluate the controls needed for maintaining your recommended IDS infrastructure and create a brief plan that outlines your recommendations for this maintenance. Provide a rationale for your suggestions supporting your statements with your research.
Classify the types of data included in your chosen scenario and evaluate the IT governance methodologies that apply to the classified data types. Explain which IT governance methodology would need to be implemented within each partition of the network in order to meet compliance standards
Full Answer Section
Compliance Standards:
The specific compliance standards applicable to the medical research institution include:
- HIPAA (Health Insurance Portability and Accountability Act): This federal law protects the privacy and security of patients' protected health information (PHI).
- FDA (Food and Drug Administration): This federal agency regulates medical research and requires institutions to adhere to strict data security and privacy standards.
- GCP (Good Clinical Practice): These international ethical and scientific quality standards govern clinical research involving human participants.
Network Design:
The recommended network design for the medical research institution is a segmented network with a DMZ (demilitarized zone). This design separates sensitive data (e.g., patient information, research data) from publicly accessible resources and internet access.
Network Segmentation:
The network should be segmented into the following zones:
- Administrative Zone: This zone houses administrative functions and systems like email servers, file servers, and employee workstations.
- Research Zone: This zone hosts research data and applications used by researchers.
- Clinical Zone: This zone houses clinical systems used for patient care and data collection.
- DMZ: This zone hosts public-facing web servers and other systems that require internet access but do not store sensitive data.
Firewall Implementation:
Firewalls should be implemented between each network zone to control traffic flow and access to sensitive data. Specific firewall types include:
- Packet-filtering firewalls: These firewalls block traffic based on IP addresses and port numbers.
- Stateful firewalls: These firewalls monitor the state of network connections and allow or deny traffic based on established connections.
- Application-layer firewalls: These firewalls inspect the content of network traffic and block malicious activity.
Intrusion Detection Systems (IDS):
IDS should be placed at strategic points in the network to detect and prevent security threats. Types of IDS include:
- Network-based IDS (NIDS): These sensors monitor network traffic for suspicious activity.
- Host-based IDS (HIDS): These sensors monitor individual systems for malicious activity.
Data Classification and IT Governance:
Data within the institution should be classified based on its sensitivity. IT governance methodologies should be implemented based on data classification:
- Public data: Requires minimal security controls.
- Internal data: Requires moderate security controls.
- Confidential data: Requires strict security controls, such as encryption and access controls.
IT Governance Methodologies:
- CMM (Capability Maturity Model): Assesses an organization's software development and process maturity.
- COBIT (Control Objectives for Information and Related Technologies): Provides a framework for IT governance and control.
- ITIL (Information Technology Infrastructure Library): Provides best practices for IT service management.
Maintenance:
IDS maintenance includes:
- Regular updates: These updates ensure that the IDS is up-to-date and can detect the latest threats.
- Signature tuning: This process involves configuring the IDS to identify specific threats relevant to the institution's environment.
- Log analysis: Regularly reviewing IDS logs can help identify security incidents and trends.
Business Reasons for Implementing Compliance Standards:
- Protecting sensitive data: Compliance with standards like HIPAA and FDA ensures that patient information and research data are protected from unauthorized access and disclosure.
- Reducing legal and regulatory risks: Compliance minimizes the risk of fines, penalties, and lawsuits resulting from data breaches or non-compliance.
- Improving patient trust: Patients are more likely to trust institutions that demonstrate a commitment to data security and privacy.
- Enhancing research integrity: Adherence to GCP standards ensures the validity and reliability of research data.
- Gaining competitive advantage: Compliance with regulations can give institutions a competitive edge in attracting funding and partnerships.
Conclusion:
This compliance plan provides a roadmap for the medical research institution to meet its professional and governmental compliance standards. Implementing the recommended network design, network segmentation, firewall implementation, IDS placement, data classification, and IT governance methodologies will help the institution protect sensitive data, comply with regulations, and safeguard its research integrity.
Sample Answer
Compliance Plan for Medical Research Institution
Introduction:
This plan outlines a strategy for the research institution mentioned in the scenario chosen and researched in week 2 to meet its professional and governmental compliance standards. The plan addresses network design, network segmentation, firewall implementation, intrusion detection systems (IDS), data classification, and IT governance methodologies.