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2. What are the major regulations and standards dictating cybersecurity action?

To be fair, the question of which regulations and standards affect how an organization implements cybersecurity is a most difficult one to answer. Not only do related regulations and standards vary by industry, they also vary by geography, complexity, and ease of implementation. Let's turn to the relatively dramatic example of data retention. Consider this statement:

The system shall have a mechanism to securely retain data in the system for a specific time period and enable protections that ensure the accurate and ready retrieval of that data throughout the records retention period.

Through recent updates to LIMSpec, the following national and international regulations, standards, and guidance (Table 1) that tie into data retention and the protection of that retained data have been found (and that list will certainly continue to grow):

Table 1. Regulations, standards, and guidance affecting data retention and the security of retained data 7 CFR Part 331.17 (c) 9 CFR Part 121.17 (c) 21 CFR Part 11.10 (c) 21 CFR Part 58.195 21 CFR Part 211.180 21 CFR Part 212.110 (c) 21 CFR Part 225.42 (b-8) 21 CFR Part 225.58 (c–d) 21 CFR Part 225.102 21 CFR Part 225.110 21 CFR Part 225.158 21 CFR Part 225.202 21 CFR Part 226.42 (a) 21 CFR Part 226.58 (f) 21 CFR Part 226.102 21 CFR Part 226.115 21 CFR Part 312.57 21 CFR Part 312.62 21 CFR Part 606.160 (d) 21 CFR Part 812.140 (d) 21 CFR Part 820.180 (b) 29 CFR Part 1910.1030 (h-2) 40 CFR Part 141.33 40 CFR Part 141.722 40 CFR Part 704 Subpart A 40 CFR Part 717.15 (d) 42 CFR Part 73.17 (c) 42 CFR Part 493.1105 42 CFR Part 493.1283 45 CFR Part 164.105 45 CFR Part 164.316 45 CFR Part 164.530 AAFCO QA/QC Guidelines for Feed Laboratories Sec. 2.4.4 or 3.1 AAVLD Requirements for an AVMDL Sec. 4.10.1.2 AAVLD Requirements for an AVMDL Sec. 4.10.2.1 AAVLD Requirements for an AVMDL Sec. 5.4.3.2 ABFT Accreditation Manual Sec. E-33 AIHA-LAP Policies 2018 2A.7.5.1 ASCLD/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 4.14.1.2 and 4.15.1.2 ASCLD/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.9.3.6 and 5.9.7 ASTM E1578-18 E-17-4 CJIS Security Policy 5.3.4 CJIS Security Policy 5.4.6–7 CJIS Security Policy 5.5.2.1 E.U. Annex 11-7.1 E.U. Commission Directive 2003/94/EC Article 9.1 E.U. Commission Directive 2003/94/EC Article 11.4 EPA 815-R-05-004 Chap. III, Sec. 15 EPA 815-R-05-004 Chap. IV, Sec. 8 EPA ERLN Laboratory Requirements 4.9.18 EPA ERLN Laboratory Requirements 4.11.17 EPA QA/G-5 2.1.9 ISO 15189:2012 4.3 ISO/IEC 17025:2017 8.4.2 NIST 800-53, Rev. 4, AT-4 NIST 800-53, Rev. 4, AU-11 and AU-11(1) NIST 800-53, Rev. 4, SI-12 OECD GLP Principles 10 USDA Administrative Procedures for the PDP 5.4 USDA Sampling Procedures for PDP 6.5 WHO Technical Report Series, #986, Annex 2, 15.8–9

You'll notice many nods to U.S. Code of Federal Regulations (CFR), as well as E.U. law, agency requirements, accreditation requirements, standards, and guidelines for just this one system specification and security control. Additionally, there are surely other entities not listed in Table 1 that demand this requirement out of information system users. This example illustrates the complexity of making a complete and accurate list of regulations, standards, guidance, and other bodies of work demanding data protection from organizations.

That said, other types of legislation and standards relevant to cybersecurity stand out. Examples of legislation that mandates cybersecurity action include 23 NYCRR 500, the Federal Information Systems Management Act (FISMA), the General Data Protection Regulation (GDPR), the Gramm-Leach-Bliley Act, the Health Insurance Portability and Accountability Act of 1996 (HIPAA), IC Directive 503, the Personal Information Protection and Electronic Documents Act (PIPEDA), and the Sarbanes Oxley Act. Of standards not mentioned in Table 1, ANSI UL 2900-2-1 for networked medical devices, IEEE 1686-2013 for intelligent electronic devices, and ISO/IEC 27032:2012 for cybersecurity are also representative examples of standard-based efforts to improve cybersecurity in numerous industries.

Despite the difficulty of laying out a complete picture of regulations and standards impacting cybersecurity approaches, we can confidently say a few things about those types of regulations and standards. First, the risks and consequences of poor security drive regulation and, more preferably, standardization, which in turn moves the "goalposts" of cybersecurity among organizations. In the case of regulations, those organization that get caught not conforming to the regulations tend to suffer negative consequences, providing some incentive for them to improve organizational processes. One of the downsides of regulations is that they can at times be "imprecise" or "disconnected" from what actually occurs within the organization and its information systems. Rather than focusing heavily to regulatory conformance, cybersecurity standards may, when adopted, provide a clearer path of opportunity for organizations to improve their cybersecurity culture and outcomes, particularly since standards are usually developed with a broader consensus of interested individuals with expertise in the field. In turn, the organizations that adopt well-designed standards likely have a better chance of conforming to the regulations they must, and they'll likely have more interest in maintaining and improving the goalposts of cybersecurity.

That's not to say that compliance with regulations and standards alone can stop critical risks in their tracks:

Rules and compliance can mitigate some critical risks but not all of them. Active and cost-effective risk management requires managers to think systematically about the multiple categories of risks they face so that they can institute appropriate processes for each. These processes will neutralize their managerial bias of seeing the world as they would like it to be rather than as it actually is or could possibly become.

Second, modern cybersecurity standards frameworks and controls, which help guide organizations in developing a cybersecurity strategy, are typically harmonized with other standards and updated as business processes, technologies, cyber threats, and even regulations evolve. For example, the industry-specific Water Sector Cybersecurity Risk Management Guidance v3.0, which contains a set of cybersecurity controls as they relate to the water and wastewater sectors, is harmonized with the NIST Cybersecurity Framework. And NIST's Special Publication 800-171, Revision 1: Protecting Controlled Unclassified Information in Nonfederal Systems and Organizations has controls mapped to ISO/IEC 27001:2013 controls. These and other signs point to some consolidation of thought on influential cybersecurity standards, as well as what constitutes relevant and necessary action towards preparing an organization to be more prepared for cyber threats and their potential consequences.

Third, when it comes to the question of what regulations are driving an organization to embrace cybersecurity, the general answer is "it's specific to each organization." While it's true that industries have their own regulations, and organizations in those industries often share the same set of challenges, additional factors such as regional requirements (e.g., the European Union General Data Protection Regulations [GDPR] and California Consumer Privacy Act [CCPA]) and even local requirements (e.g., privacy rules and guidelines, banning of specific technology in a city) will affect how the organization must operate. This information gathering process is a unique aspect of organizational cybersecurity planning; in the end it's up to the organization to "identify all obligatory cybersecurity requirements and controls with which it must comply." Armed with that information, the organization can integrate those identified requirements and controls with an existing baseline framework of broad and industry-specific cybersecurity controls, as well as any internal standards and control objectives specific to the organization and its policy requirements.

2.1 Cybersecurity standards frameworks

What are cybersecurity standards? CGI, Inc. calls them "critical means by which the direction described in an enterprise’s cybersecurity strategy and policies are translated into actionable and measurable criteria." They contain a set of statements about what processes must be followed to achieve the security outcomes expected by the organization. Sometimes those standards get placed within a framework, which adds additional policy, procedure, and process to the set of statements laid out in the standards. This resulting cybersecurity standards framework acts as a defined, collective approach to how the information system, data, and services are managed within the organization.

Some experts further differentiate between frameworks. Frank Kim, founder of security consulting firm ThinkSec and curriculum director at the SANS Institute, splits frameworks into three categories: control, program, and risk frameworks. Control frameworks provide a baseline set of controls for assessing technical capability, prioritizing implementation, and developing a cybersecurity plan. Program frameworks offer a more program-based approach, allowing organizations to broadly assess the current state of their cybersecurity program and further develop it. Risk frameworks "allow cybersecurity professionals to ensure they are managing their program in a way that is useful to stakeholders throughout the organization, and help determine how to prioritize security activities." Data communications and security specialist Robert Slade does something similar using slightly different terminology. Checklist frameworks are the equivalent of Kim's control frameworks, governance frameworks appear to be Kim's program frameworks, and risk management frameworks represent Kim's risk frameworks. Slade adds a fourth category, however: audit and assurance.

Numerous cybersecurity standards frameworks exist, some based in specific countries, others based on specific industries. According to at least one authority, the top four cybersecurity standards frameworks being leveraged by organizations are the Payment Card Industry Data Security Standards (PCI DSS), ISO/IEC 27001:2013, Center for Internet Security (CIS) Controls, and the NIST Cybersecurity Framework. These and a selection of additional cybersecurity standards frameworks and standards are shown in Table 2:

Table 2. Examples of cybersecurity standards frameworks and standards Name Developer Framework type Industry ANSI/ISA 62443 Standards ISA Control and Program Industrial automation and control systems Baseline Cyber Security Controls for Small and Medium Organizations Canadian Centre for Cyber Security Control Industry-neutral; small and medium organizations Center for Internet Security (CIS) Controls Center for Internet Security Control Industry-neutral Cloud Controls Matrix Cloud Security Alliance Control Cloud services and implementation Code Quality Standards Consortium for Information & Software Quality Control Software development Control Objectives for Information and Related Technologies (COBIT) Information Systems Audit and Control Association Program Industry-neutral Critical Infrastructure Protection (CIP) Standards North American Electric Reliability Corporation Control Utilities Cybersecurity Assessment Tool Federal Financial Institutions Examination Council Control Financial services Essential Cybersecurity Controls (ECC - 1: 2018) National Cybersecurity Authority of Saudi Arabia Control Industry-neutral ETSI TR 103 305 V1.1.1 European Telecommunications Standards Institute Control Telecommunications Federal Information Processing Standards (FIPS) National Institute of Standards and Technology Control Industry-neutral HISO 10029:2015 Health Information Security Framework New Zealand Ministry of Health Control Healthcare HITRUST CSF HITRUST Alliance Risk Industry-neutral ISO/IEC 15408-1:2009 International Organization for Standardization Program Industry-neutral ISO/IEC 27001:2013 International Organization for Standardization Program Industry-neutral NIST Cybersecurity Framework National Institute of Standards and Technology Program Industry-neutral NIST SP 800-53, Rev. 4 Security and Privacy Controls for Federal Information Systems and Organizations National Institute of Standards and Technology Control Industry-neutral; U.S. federal information systems and organizations NIST SP 800-171, Rev. 1 Protecting Controlled Unclassified Information in Nonfederal Systems and Organizations National Institute of Standards and Technology Control Industry-neutral; U.S. non-federal information systems and organizations OCTAVE Allegro Software Engineering Institute Risk Industry-Neutral Payment Card Industry Data Security Standards (PCI DSS) V3.2.1 PCI Security Standards Council, LLC Control "All entities involved in payment card processing" Protective Security Requirements New Zealand Security Intelligence Service Program Industry-neutral Secure Controls Framework Secure Controls Framework Council, LLC Control Industry-neutral Sherwood Applied Business Security Architecture (SABSA) The SABSA Institute C.I.C. Program and Risk Enterprise-level business Standard of Good Practice for Information Security 2018 Information Security Forum Ltd. Control Industry-neutral System and Organization Controls for Cybersecurity (SOC-C) Association of International Certified Professional Accountants Control Industry-neutral Water Sector Cybersecurity Risk Management Guidance v3.0 American Water Works Association Risk Water and wastewater

Choosing the appropriate frameworks requires consideration and research. For the purposes of this guide, NIST SP 800-53, Rev. 4 and, to a lesser degree, the NIST Cybersecurity Framework receive the most focus. That is not meant to dissuade organizations from using other frameworks. For example, the PCI DSS is heavily geared to the financial services industry and is industry-appropriate for those working with credit card transactions. However, additional controls from other frameworks may also be of use. In fact, more than 40 percent of organizations work with more than one set of cybersecurity controls when developing their cybersecurity plan. NIST SP 800-53, Rev. 4 and the NIST Cybersecurity Framework are particularly appealing though, having been developed with thousands of stakeholders giving feedback, and in such a way that the controls remain "intuitive and accessible to a wide range of practitioners."