Month: April 2022

What does HIPAA Risk Assessment covers

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All risk assessments, HIPAA – related policies and reasons why addressable safeguards have not been implemented must be chronicled in case a breach of PHI occurs and an investigation takes place to establish how the breach happened. Each of the HIPAA requirements is explained in further detail below. Business unsure of their obligation to comply with the HIPAA requirements should seek professional advice.

What should a Risk Assessment consist of?

Throughout the HIPAA regulations, there is a lack of guidance about what a HIPAA risk assessment should consist of. OCR explains the failure to provide a “specific risk analysis methodology” is due to Covered Entities and Business Associates being of different sizes, capabilities, and complexity.

However, OCR does provide guidance on the objectives of a HIPAA risk assessment:

  1. Identify the PHI that your organization creates, receives, stores and transmits – including PHI shared with consultants, vendors and Business Associates.
  2. Identify the human, natural and environmental threats to the integrity of PHI – human threats including those which are both intentional and unintentional.
  3. Assess what measures are in place to protect against threats to the integrity of PHI, and the likelihood of a “reasonably anticipated” breach occurring.
  4. Determine the potential impact of a PHI breach and assign each potential occurrence a risk level based on the average of the assigned likelihood and impact levels.
  5. Document the findings and implement measures, procedures, and policies where necessary to tick the boxes on the HIPAA compliance checklist and ensure HIPAA compliance.
  6. The HIPAA risk assessment, the rationale for the measures, procedures and policies subsequently implemented, and all policy documents must be kept for a minimum of six years.

As mentioned above, a HIPAA risk assessment is not a one-time requirement, but a regular task necessary to ensure continued compliance. The HIPAA risk assessment and an analysis of its findings will help organizations to comply with many other areas on our HIPAA compliance checklist and should be reviewed regularly when changes to the workforce, work practices or technology occur.

Depending on the size, capability, and complexity of a Covered Entity, compiling a fully comprehensive HIPAA risk assessment can be an extremely long-winded task. There are various online tools that can help organizations with the compilation of a HIPAA risk assessment although, due to the lack of a “specific risk analysis methodology”, there is no “one-size-fits-all solution.

The OCR pilot audits identified risk assessments as the major area of Security Rule non-compliance. Risk assessments are going to be checked thoroughly in the second phase of the audits not just to make sure that the organization in question has conducted one, but to ensure they are comprehensive and ongoing. A risk assessment is not a one-time requirement, but a regular task necessary to ensure continued compliance.

The difference between the “required” safeguards and the “addressable” safeguards on the HIPAA compliance checklist is that “required” safeguards must be implemented whereas there is a certain amount of flexibility with “addressable” safeguards. If it is not reasonable to implement an “addressable” safeguard as it appears on the HIPAA compliance checklist, covered entities have the option of introducing an appropriate alternative, or not introducing the safeguard at all.

That decision will depend on factors such as the entity’s risk analysis, risk mitigation strategy and what other security measures are already in place. The decision must be documented in writing and include the factors that were considered, as well as the results of the risk assessment, on which the decision was based.

GDPR : Who does it Cover and Requirements ?

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This article is part of our GDPR compliance consultancy services hub page, designed to help businesses understand GDPR scope, applicability, and compliance requirements. In this blog, we explain who GDPR applies to, which organizations need to comply, and the key requirements for protecting personal data when handling information of individuals covered under the regulation.

On May 25, 2018, the EU’s 1995 Data Protection Directive and all member state laws based on it were replaced by the GDPR (General Data Protection Regulation), a pan-European data protection regulation. The GDPR introduces a 21st-century approach to data protection with its significant and extensive scope. It gives people more control over how their personal data is gathered and processed and gives organisations (both controllers and processors) several additional requirements to be more accountable for data protection. The Data Protection Act of 2018 in Ireland, which took effect on May 25, 2018, complies with the GDPR’s limited chances for member states to create provisions or derogations for how the Regulation applies in their nation.

Who is covered by the GDPR?
  • Even if they are not EU citizens, all EU organisations that gather, store, or otherwise process the personal data of people who reside in the EU.
  • Companies situated outside of the EU that provide goods or services to residents there, observe their behaviour, or handle their personal data.
GDPR requirements are:
1. Accountability and Governance
You must be able to demonstrate compliance with the GDPR. This includes:
  • creating a system for governance with jobs and duties.
  • keeping thorough records of each and every data processing operation.
  • preserving policies and practises for data protection.
  • conducting DPIAs (data protection impact assessments) for processing procedures that pose a high risk.
  • putting in place the necessary safeguards to protect personal data.
  • training for staff members’ awareness.
  • appointing a data protection officer as necessary.
2. The six data processing principles
Six data processing principles are outlined in the GDPR and must be followed by data controllers. Personal information must be:
  • Processed lawfully, fairly and transparently.
  • Collected only for specific legitimate purposes.
  • Adequate, relevant and limited to what is necessary.
  • Accurate and, where necessary, kept up to date.
  • Stored only as long as is necessary.
  • Processed in a manner that ensures appropriate security.
3. Lawful processing
Personal data can only be treated in the following ways, with the exception of particular categories of data, which cannot be processed except in certain circumstances:
  • If the data subject has given their consent
  • To meet contractual obligations
  • To comply with legal obligations
  • To protect the data subject’s vital interests
  • For tasks in the public interest
  • For the legitimate interests of the organisation
4. Data subjects’ rights
Data subjects have:
  • The right to be informed
  • The right of access
  • The right to rectification
  • The right to erasure
  • The right to restrict processing
  • The right to data portability
  • The right to object and
  • Rights concerning automated decision-making and profiling.
5. Valid consent
There are stricter rules regarding consent:
  • Freely granted, specific, informed, and unambiguous consent is required.
  • A request for consent must be understandable and written in unambiguous terms.
  • Consent will no longer be accepted in the form of inaction, pre-ticked boxes, or silence.
  • Anytime can be used to revoke consent.
  • Only with parental approval is a child’s internet service consent legitimate.
  • Organizations are required to provide proof of permission.
6. Data protection by design and by default
Data controllers and processors are required to put in place organisational and technical measures that are intended to effectively apply the data processing principles.
  • The processing should incorporate the necessary safeguards.
  • Any new procedure, system, or technological advancement must take data protection into account during the design phase.
  • An essential component of privacy by design is a DPIA (data protection impact assessment).
7. Transparency and privacy notices
Organizations must be transparent about how, why, and who will process personal data.
  • Data controllers are required to give data subjects a privacy notice when collecting personal information directly from them.
  • Data controllers shall deliver a privacy notice without undue delay and within a month where personal data is not collected directly from data subjects. The first time they speak with the data subject, they must do this.
  • Data controllers must decide how the data subjects will be informed for all processing activities and then write privacy notices accordingly. Notices may be given out gradually.
  • Data subjects must get privacy notices in a clear, visible, and easily available format using plain English.
8. Data transfers outside the EU
After the transition period is through, many non-EU organisations that process the personal data of EU citizens must also appoint an EU representative.
  • When a nation has been recognized by the EU as offering a sufficient level of data protection
  • through standard contractual provisions or legally binding business practices
  • by adhering to an accepted certification procedure.
9. Mandatory data breach notification
A breach of security that results in the unintentional or unlawful destruction, loss, alteration, unauthorized disclosure of, or access to, personal data that is transmitted, stored, or otherwise processed is referred to as a personal data breach under the GDPR.
  • All breaches of personal data must be reported to data controllers by data processors.
  • If there is a threat to the rights and freedoms of data subjects, data controllers are obligated to notify breaches to the supervisory authority (the Data Protection Commission (DPC) in Ireland) within 72 hours of becoming aware of them.
  • If there is a significant risk to the rights and freedoms of the data subjects, they must be informed without undue delay.
10. DPOs (data protection officers)
You must be able to show that the GDPR is being followed. This comprises:
  • establishing a system for governance with positions and duties
  • maintaining a thorough log of all data processing activities
  • maintaining policies and practises for data protection
  • performing DPIAs (data protection impact assessments) for processing processes that pose a high risk
  • putting in place the necessary safeguards to protect personal data
  • whenever necessary, conducting staff awareness training and establishing a data protection officer

Understanding Various Levels Of Merchants Service Provider

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Any Merchant and Service provider Reporting a PCI DSS Compliance by two different validation methods:

  1. Self-Assessment Questionnaire (SAQ)
  1. SAQ is a validation tool for merchants and service providers to report the results of their PCI DSS self-assessment, if they are not required to submit ROC
  2. Includes a series of yes-or-no questions for each applicable PCI DSS requirement
  3. Different SAQs available to meet different merchant environments.

B. Onsite Assessment by Qualified Security Assessor

  1. Onsite assessment is a validation mechanism for merchants and service providers by a Qualified Security Assessor (QSA)
  2. QSA submits the Report on Compliance (ROC) and attestation Of Compliance (AOC)
  3. QSA and authorized  person at merchant/service provider entity require to sign the AOC
  1. How to identify what applies to your organization? SAQ or Onsite Assessment?
  1. If you are a merchant, depends on your annual transactions per year across all channels, payment card brands defined four levels.
  2. If you are a service provider, depends on your annual transactions per year across all channels, payment card brands defined two levels.
  3. All levels, except Level 1, must complete a self-assessment questionnaire as well as have a quarterly external vulnerability scan using an Approved Scanning Vendor (ASV).
  1. Merchants PCI Compliance Levels:

Definition of Merchant: The entity directly provide service and/or Product to the End customer and get the Money through various channels. Examples like Hotels, Restaurants, Airlines, Hospitals, Online Shopping Portals etc.,

Note: Depends on the Type of SAQ Applicable for your organization, there is a need of performing Internal Vulnerability scans and Penetration testing. Read our Blog on Type of SAQ’s.

  1. Service Providers PCI Compliance Levels:

Definition of Service Provider: Business entity that is not a payment brand, directly involved in the processing, storage, or transmission of cardholder data on behalf of other entity. This also includes companies that provide services that control or could impact the security of cardholder data. Examples like Hosting Service Providers, Card Printing Services, Backup Services Providers, Managed Service Providers, Security Management, Contact Centres and/or Back office Processing companies etc.,

Receiving a Report on Compliance (ROC) and validating as a Level 1 Service Provider allows entities to be on Visa’s Global Registry of Approved Service Providers. Which will help the entities recognized  as a Trusted service provider and useful for Pitching for the new business opportunities.

Guide to ISO/IEC 27701:2019 Clauses

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The worldwide standard for a privacy information management system is ISO/IEC 27701. (PIMS). It is a privacy addition to ISO/IEC 27002 Security Controls and ISO/IEC 27001 Information Security Management.

These are some particular organisational roles:

  • PII controllers (among them are those who act as joint PII controllers)
  • PII processors

Following are the clauses mentioned in ISO 27701:

Clause 1: Scope

In here, the prerequisites for the management system’s intended use are outlined. As an addition to ISO/IEC 27001 and ISO/IEC 27002, ISO/IEC 27701 aims to provide rules and recommendations for setting up, implementing, maintaining, and improving a privacy information management system. focused on the individuals who are in charge of and accountable for handling PII, including PII controllers and PII processors.

Clause 2: Normative references

Documents cited in a standard are considered normative references. These include: ISO/IEC 27000 Overview and vocabulary for information security management systems ISO/IEC 27001 Information security management systems: requirements The ISO/IEC 27002 Code of Practice for Information Security Controls Framework for privacy established by ISO/IEC 29100

Clause 3: Terms and definitions

Important terminology used throughout the standard that are not defined in ISO/IEC 27000 and ISO/IEC 29100 are given a few extra definitions in this section.

Clause 4: General

In relation to ISO/IEC 27701, this clause “sets the scene.” It gives a high-level overview of the document’s organisation and identifies where the PIMS-specific requirements are located in reference to ISO/IEC 27001 and ISO/IEC 27002.

Clause 5: PIMS specific requirements related to ISO/IEC 27001

The purpose of this clause is to incorporate the protection of privacy into the information security criteria of ISO/IEC 27001 as well.

Determine your function as a processor and/or controller within the framework of the company, and take into account the influence of internal and external elements including privacy-specific rules and contractual requirements. Depending on your function, you must implement and apply the pertinent controls from Annexes A and/or B to your current statement of applicability.

Additionally, you must take into account the parties with an interest in the processing of PII, the scope of your PIMS, and the efficient implementation, upkeep, and ongoing improvement of the system. To ensure the protection of privacy, consideration and extension of ISO/IEC 27001’s requirements for management, planning, support, operation, performance evaluation, and improvement must be taken into account. Risks to information and processing of PII must now be evaluated and handled carefully, in particular.

Clause 6: PIMS specific guidance related to ISO/IEC 27002

This clause aims to expand ISO/IEC 27002’s information security recommendations to include privacy protection.

For instance, based on compliance, contractual, and stakeholder needs, enterprises need to take into account the extra implementation guidance regarding information security policies to incorporate pertinent privacy declarations.

Roles and duties in respect to the processing of PII are described with greater clarity. This includes being informed of incident reporting requirements and the repercussions of a privacy violation.

Advice is provided to guarantee that PII is taken into account while classifying your information. You must be aware of the PII your company handles, where it is kept, and the systems it passes through. Additionally, people need to know what PII is and how to spot it.

On incident management, removable media, user access on PII processing systems and services, cryptographic protection, reassigning PII storage space, back-up and recovery of PII, event log reviews, information transfer policies, and confidentiality agreements, more thorough implementation guidance is provided.

Additionally, this clause’s instructions encourage you to take PII into account before transmitting data over open networks and as part of the system’s development and design. Relationships with suppliers as well as their expectations and obligations must be addressed.

Clause 7: Additional guidance for PII controllers

This section deals with PIMS-specific implementation advice for PII controllers. It is associated with the measures detailed in Annex A.

For instance, in order to be in compliance with the laws that apply, you must specify the precise purposes for the PII you process and have a legal justification for doing so. If the intent behind processing PII evolves or expands, updates should be made.

Aside from these topics, the guidance also outlines contracts with PII processors, clear roles and responsibilities with any joint controllers, considerations of special category data and consent requirements, privacy impact assessment requirements to reduce risk to PII principals, and considerations of special category data and considerations.

People whose PII you process should understand why and how information is processed, along with a point of contact for inquiries. On consent, withdrawals, and PII access, correction, or deletion, specific instructions are provided. Additionally offered are third-party obligations, managing requests, and automated decision-making advice.

The accuracy and quality of PII, constraints on the amount collected based on the purpose of processing, and end of processing criteria should all be taken into account when implementing privacy by design for processes and systems. Importantly, PII sharing, transfer, and disclosure information is provided to assist you in moving your records between jurisdictions.

Clause 8: Additional guidance for PII Processors

This section addresses implementation advice for PII processors particular to PIMS. The restrictions indicated in Annex B are relevant.

For instance, in order to help customers meet their obligations, including those of PII principles, customer contracts should mention your company’s function as a PII Processor. To utilise PII data for marketing and advertising, prior consent is required.

There is advice provided on how to locate and keep track of the records required to prove compliance with the agreed-upon PII processing you carry out.

Detailed instructions are provided on how to assist your customer with specific requests, manage temporary files created during processing, return, transfer, or securely dispose of PII, and use the proper transmission controls.

In order to accommodate jurisdictional transfers, third-party and subcontractor requirements, and management of legally enforceable PII disclosures, thorough PII sharing, transfer, and disclosure guidance is provided.

Annexes

The ISO/IEC 27701 standard contains a number of Annexes. While annexes C–F contain additional information that can help with setting up and running an effective PIMS, annexes A and B are for controllers and processors, respectively. Following are covered in Annexes:

Annex A

An inventory of PII controller controls. A reason for any control that is excluded must be included in the statement of applicability even though not all controls will be necessary.

Annex B

An inventory of PII processor controls. A reason for any control that is excluded must be included in the statement of applicability even though not all controls will be necessary.

Annex C

Controls for PII controllers are mapped to the privacy principles in ISO/IEC 2900. This illustrates how compliance with ISO/IEC 27701’s requirements and controls relate to the privacy principles in ISO/IEC 29100.

Annex D

Articles 5 to 49 of the GDPR are mapped to the provisions in ISO/IEC 27701 (except 43). This demonstrates how fulfilling GDPR regulations might be relevant to conforming to ISO/IEC 27701 requirements and controls.

Annex E

Clauses in ISO/IEC 27701 mapped to:

  • Requirements for PII processors in public clouds under ISO/IEC 27018
  • ISO/IEC 29151 for guidelines and extra controls for PII controllers.

Annex F

Provides information on how to apply ISO/IEC 27701 to ISO/IEC 27001 and ISO/IEC 27002. It offers various application examples as well as a clear map of how information security words are extended to encompass privacy.

Controls Guide for ISO 27001 – Part 1

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This article is part of our ISO 27001 compliance and certification hub page, created to help organizations understand the standard, its requirements, and its role in information security management. In this first part of the ISO 27001 controls guide, we explain the foundational controls that support risk management, data security, and a structured approach to protecting business-critical information.

An international standard called ISO/IEC 27001:2013 was developed to assist enterprises in managing the security procedures for their information assets. This standard offers a reliable framework for putting into place an ISMS, or Information Security Management System. Through its safe and efficient management procedures, this framework facilitates the Confidentiality, Integrity, and Availability of all crucial organizational data.

One of the most widely used and approved information security standards is ISO 27001. You can refer to our prior article for more information because we already covered everything you need to know about the ISO 27001 standard. The focus of this essay is on the ISO 27001 Audit Controls, nevertheless. The paper describes the ISO27001 Audit Controls in great detail.

What are the audit controls for ISO 27001?

There are two sections to the ISO 27001 Audit Control Standards.11 clauses, ranging from 0 to 10, make up the first section, which is the required element. 114 control objectives and controls are outlined in the second section, known as Annex A. The Introduction, Scope, Normative references, and Terms and Definitions of the ISO 27001 standard are covered in Clauses 0 to 3.

Any business that wants to be in compliance with the Standard must adhere to the ISO 27001 requirements listed in Clauses 4 through 10. The Standard’s Annex A provides a list of optional controls that are chosen as part of the Risk Management process to support these clauses and their requirements. 14 categories can be used to group the 114 controls in ISO 27001 Annex A, which we will explore below.

ISO/IEC 27001 Information Security Management Standard – Clauses 0 – 10

  1. Clause 0.1: Introduction  – The knowledge needed to put up a successful Information Security Management System is provided by the ISO 27001 Standard. This system provides an overview of how the standard implementation safeguards your data from unauthorized  users, complies with numerous national and international compliance standards, and inspires confidence in stakeholders and clients as a reliable business.
  2. Clause 1: Scope  – According to this clause, your organization’s context must be considered when applying the ISO 27001 standard’s specifications. So it’s crucial to understand your organizational  setting. This prevents you from overworking your system and attempting to accomplish goals that are unnecessary. It is stated again in the provision that your ISMS must apply risk management procedures. It also demonstrates how this norm applies to businesses of all sizes.
  3. Clause 2: Normative references  – This Clause exists to indicate that application of ISO 27001 requires ISO 27000. As a result, while developing your ISMS, you must read, comprehend, and apply the criteria of ISO 27000.
  4. Clause 3: Terms and Conditions  – The fact that all the criteria and conditions stated in this Clause also apply to ISO 27001 is another crucial reason why you should first grasp ISO 27000.
  5. Clause 4: Context of the organization  – This clause mandates that the organisation identify all internal and external concerns that might be pertinent to its business goals and the realization  of the ISMS’s own objectives.
  6. Clause 5: Leadership  – To ensure a seamless implementation of the ISMS, this clause mandates that top management duties be clarified, along with the roles and responsibilities and the contents of the top-level Information Security Policy.
  7. Clause 6: Planning  – The “preventive action” described in the previous version of ISO 27001:2005 is covered by clause no. 6. It lays out exactly what is needed in terms of risk assessment, risk management, Statements of Applicability, and Risk Treatment Plans, as well as how these fit together and make it easier to set up the ISMS.
  8. Clause 7: Support  – The next clause specifies that the organisation must establish and make resources necessary by the ISMS team to the team deploying the system available in order to achieve the specified objectives and demonstrate constant improvement. It aims to outline the prerequisites for resource accessibility, skill levels, awareness, communication, and document and record control.
  9. Clause 8: Operation  – This clause aims to guarantee that security goals are reached, risks and opportunities are handled appropriately, and information security regulations are adhered to. It outlines how risk assessment should be implemented as well as other procedures required to meet information security goals.
  10. Clause 9: Performance evaluation  – This clause addresses the ongoing measurement, analysis, performance assessment, and monitoring of the ISMS. These practices are critical components of an effective IS audit.  As a result, this Clause aims to provide precise measuring metrics by defining the standards for the organization’s monitoring, measurement, analysis, evaluation, internal audit, and management review.
  11. Clause 10: Improvement  – The requirements for nonconformities, corrections, corrective actions, and continuous improvement are outlined in this section.

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