ISO 27001 Healthcare

ISO 27001 Standard & 27000 Frameworks for the Health Care Sector

ISO 27001, information security management standard is becoming an increasingly popular compliance framework for healthcare providers and medical device manufacturers.

The confidentiality of patient data in the healthcare sector is of vital importance.

The amount of sensitive information held by the healthcare industry makes institutions attractive target for a data breach.

The healthcare sector holds sensitive patient data, has a need to share personal information and information assets securely between departments and suppliers.

It is no surprise that cyber security and information security are one of the primarily regulatory concerns for healthcare IT decision makers. A cyber security incident or breach would be financially and reputationally damaging to any healthcare institution.

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ISO 27001 for Health Care Providers

ISO/IEC 27001 is primarily concerned with the application of security controls to protect the confidentiality, integrity and availability of information assets. These can include but are not limited to:

  • Patient data/records
  • Financial records
  • Research
  • Supplier data
  • Vendor/Market Suppliers
  • IT Infrastructure
  • Contracts & Agreements

In addition to ISO 27001 there are several frameworks that are recommended for IT governance within a healthcare setting and for medical device manufacturers.

The ISO/IEC 27000 Family of Information Security Standards

ISO 27001 and ISO 27002 are the mainstay of the series. They specify the requirements for an ISMS, and are a must for any healthcare institution serious about information security management & compliance. It is worth noting that whilst comprehensive ISO 27001 controls are weighted towards the protection of information assets and are not suitable to ensure full compliance with GDPR and similar privacy legislation.

What Is Lacking in ISO 27001 for Data Privacy?

ISO 27001 specifies the requirement for a comprehensive information security management system.

Data protection legislation (such as the GDPR, APPs, POPIA or CCPA) naturally require organisations implementing technologies to adhere to a certain amount of technical and organisational information security standards & measures to protect personal data.

However, this is only part of the picture; organisations must also protect the rights of the individuals whose data is being handled. Information security alone cannot guarantee that.

Extending ISO 27001 for Data Privacy Compliance

ISO 27701 compliments ISO 27001 by adding privacy-specific controls, providing framework to convert an ISMS to a Privacy Information Management System (PIMS). ISO 27799 augments ISO 27002 and introduces health care specific information security controls and best practices extending the scope of ISO 27001 to include revised health sector specific framework.

Why ISO 27001 for Healthcare – What Are the Benefits?

When it comes to patient safety in healthcare institutions, information security management is critical.

The data in patient journals and laboratory reports are sensitive and should only be accessible by those with proper authorisation.

In order to maintain safety and ensure correct medical treatment based on correct data, timely access to updated information is important for medical personnel.

Regulatory fines from a breach could run into the millions, in the worst case, failing to provide necessary patient or medical information could result incorrect medication being issued, death, incorrect operation of procedures.

If you are a provider of such services, getting external certification will show your clients, stake holders and suppliers that information security is now more than ever a priority for your organisation.

ISO 27001 has developed into a globally recognized baseline for information security in the last 10 years. In this context, ISO 27001 is one of the few standards that really stands out. It is so much more than just another “check-the-box” standard. It has been embraced and implemented by some of the world’s largest and most sophisticated organisations.

Your business can’t afford not to have an information security program. We can help you with the implementation of ISO 27001 and certification of your ISMS, we make entire process fast, cost-effective and easy to follow.

How ISO 27001 Supports Your Business

A certified information security management system demonstrates commitment to the protection of information and provides confidence that these assets are protected by:

  • Control, management and handling of information held by your institution.
  • Demonstrates that your organisation takes a proactive approach to securing vital information and data management.
  • Demonstrates Risk Management related to handling of information.
  • Demonstrates compliance with international and national legislation.
  • Demonstrates resilience and a robust business continuity policy in case of natural disasters, information security incidents or similar to ensure continuity of operations.
  • Patients, authorities, investors, suppliers and other stakeholders are reassured that sensitive information is safe.

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ISO 27799, Framework Explained

ISO 27799 aims to address information security management challenges affecting hospitals. It does not replace ISO/IEC 27001/27002, rather it complements the standard.

This framework provides guidelines to implement information security controls in healthcare organisations based on ISO/IEC 27001 and 27002. This ensures healthcare institutions adopt sector specific information security controls.

Why Are Information Security Management Practices Critical in Healthcare?

ISO 27799 provides instructions for the protection of data privacy and data protection rights. The benefits of this Standard are applicable in all healthcare facilities regardless of size, level of complexity. Healthcare organisations use technological infrastructure, information systems, information assets that are highly vulnerable to vulnerability and data theft.

How ISO 27001 and ISO 27799 Complement Each Other in Healthcare Organisations?

ISO 27001 and ISO 27002 were not specifically developed for health care institutions.

ISO 27799:2016 specifies rules for the organisation’s information security standards and information security management practices in healthcare.

It defines guidelines to promote the interpretation and implementation in health informatics of ISO/IEC 27002 and is a companion to this international Standard. It is applicable to personal health information security in any sense and regardless of how such information is displayed (words and numbers, audio recordings, pictures of doctors and other medical objects); whatever mode of processing is used (printing or printing on).

Health Informatics — Information Security Management in Health

In addition to the ISO 27000 family of standards and frameworks, there is significant overlap with quality control standards (QMS) such as, ISO 13485 and regulatory standards, such as HIPAA.

ISMS.online provides robust sets of policies and controls for the ISO 27000 family as well as mappings for HIPAA, ISO 13485 and many more.

As mentioned earlier ISO 27001 is the standard establishing the requirements for an information security management system. It can be integrated with secondary frameworks e.g. ISO 27002. In a health care environment, ISO 27799 provides sector specific controls (such as access control measures, data integrity and data quality). The integration of the ISO 27799 framework in addition to ISO 27001 makes sense, particularly for hospitals and similar healthcare institutions.

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What Is ISO 13485:2016?

ISO 13485 is an international standard for a medical device manufacturer quality management system similar to ISO 9001. It’s a requirement for organisations that make, market or supply medical devices and/or related services to demonstrate their ability to consistently to demonstrate their products and services meet specified customer and applicable regulatory requirements.

The Purpose of ISO 13485?

Adopting ISO 13485 provides a practical basis for manufacturers addressing the EU medical device directive (MDD), EU Medical Device Regulation (MDR) and other regulatory guidelines.

The Importance of ISO 13485

Even though ISO 13485 is not required for EU MDR compliance, most companies will use the ISO 13485:2016 standard as it is the only standard listed in the EU list of harmonized standards for Quality Management Systems making it de-facto compulsory.

InfoSec in Health Care and HIPAA

The Health Insurance Portability and Accountability Act (HIPAA) was established to protect patient privacy from any and all types of cyber threats & data breaches.
The Health Insurance Portability and Accountability Act sets a standard for patient data protection.

To ensure compliance with the Health Insurance Portability and Accountability Act (HIPAA), companies that deal with protected health information have to have physical, network, and process security measures in place.

Anyone who provides treatment, payment, or operations in healthcare, as well as anyone who has access to patient information and provides support in treatment, payment, or operations, must meet the requirements of the Health Insurance Portability and Accountability Act.

Subcontractors, as well as any related business associates, must be in compliance.

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The HIPAA Privacy And HIPAA Security Rules

The Health Insurance Portability and Accountability Act (HIPAA) is a United States federal law that was passed by Congress in 1996 and signed into law by President Clinton.

It aims to improve portability and continuity of health insurance coverage, and it requires providers such as doctors, dentists, hospitals, and other healthcare providers to protect the privacy of individuals’ medical records.

The Security Rule establishes national security standards for protecting specific health information that is electronically held or transferred.

ISMS.online can help with both HIPAA compliance and contains frameworks to map the HIPAA controls to equivalent ISO 27001 frameworks.

Let Us Help You Achieve ISO 27001 for Your Healthcare Institution

Achieving ISO 27001 certification show your clients, stakeholders and suppliers that information security is a priority for your institution. ISMS.online makes the process fast, ensures compliance first time with our Assured Results Method and makes it easy with our Adopt Adapt Add process and Virtual Coach.

Benefits of using ISMS.online include the ability to

  • Maintain Your ISO 27001 certification.
  • Reduce the likelihood of InfoSec breaches.
  • React to them more quickly if and when they do happen.
  • Quickly and easily demonstrate the controls you have in place.

The people you want to work with will feel confident that you’ll look after their valuable information assets and data security. Contact us today to discuss how we can help you.

Want a 77% head start on ISO 27001 certification?

Frequently Asked Questions

Why Choose ISMS.online for ISO 27001?

It can be challenging and daunting to achieve ISO 27001 certification, but with ISMS.online, it couldn’t be simpler. As well as preconfigured frameworks, tools, security controls and other content to help you quickly and easily achieve ISO 27001, ISMS.online’s features include:
  • Simple, secure, all-in-one online ISMS environment that makes management easier, faster and more efficient
  • Preloaded Adopt / Adapt / Add ISO 27001 policies and controls that start you off with 77% of your ISMS documentation already completed
  • An optional Virtual Coach to give you confidence and share 24/7, context-specific ISO 27001 help
  • Optional tools to keep your colleagues aware of and engaged with your ISMS
  • Integrated supply chain management creating end-to-end information security assurance, strengthening your supplier relationships too
And ISO 27001's not the only international standard we can help you with. Our platform can help you achieve certification in or compliance with a wide range of other standards and regulations too.

What is an Information Security Management System?

An Information Security Management System (ISMS) outlines and demonstrates an organisation’s approach to infosec. It defines how an organisation identifies and overcomes risks and opportunities that relate to its valuable information and associated assets. That begins with sensitive data and personal data, but covers much else too.

Why is ISO 27001 Important?

Implementing ISO 27001 shows all interested parties that your organisation takes infosec seriously and does as much as possible to:
  • Carry out practical, comprehensive risk assessments
  • Reduce identified risks to an acceptable level
  • Manage those risks effectively
ISO 27001's benefits include:
  • Reducing your organisation’s information security and data protection risks
  • Helping it attract new customers and retain existing clients, saving time and resources
  • Improving the reputation of and strengthening trust in your organisation
ISO 27001 will also help your organisation comply with other regulations and standards, such as privacy regulation GDPR, infosec standards Cyber Essentials and PCI DSS, and ISO 22301 which focusses on business continuity management. Overall it provides greater information security assurance. That's why so many organisations are investing in and working with certification bodies to achieve ISO 27001-certified information security management systems.

What is ISO 27001?

ISO 27001:2013 is the internationally recognised specification for an Information Security Management System (ISMS), and it is one of the most popular standards for information security. The most recent version of the standard is ISO / IEC 27001:2013 and implements improvements made in 2017 as well.

What’s the difference between ISO 27001 compliance and certification?

To achieve ISO 27001 compliance, you just need to meet the requirements of ISO 27001. You show that you're doing so by carrying out your own audits. To achieve ISO 27001 certification, you need to find an external certification body. They'll confirm that your ISMS is ISO 27001 compliant and recommend certification. ISO 27001 certification is generally seen as being more impressive than compliance because it involves that external certification process.

How long will your ISO 27001 certification last?

Your ISO 27001 certification will last for three years after your successful certification audits. During that time you'll carry out regular performance evaluation of your ISMS. You'll make sure that your senior management review it regularly. And it'll undergo external audits as well. That'll ensure your organisation's ongoing data security as it grows and cyberthreats evolve and change. Continual improvement of your ISMS is key to maintaining your certification.

Platform features

Disconnected templates and toolkits supported by an expensive consultant just don’t cut it anymore. You need an ISMS that works for you both now and as your business grows.