On October 18, 2018, the FDA published Content of Premarket Submissions for Management of Cybersecurity in Medical Devices.  This guidance outlined recommendations for cybersecurity device design and labeling as well as important documents that should be included in premarket approval submissions.  This guidance comes at a critical time as the healthcare industry is a prime target for hackers.  On January 22, 2019, the U.S. Department of Homeland Security Industrial Control System Cyber Emergency Team (US-CERT) issued another advisory regarding medical device vulnerabilities.  Further, a report by KLAS Research in collaboration with the College of Healthcare Information Management Executives (CHIME) found that 18 percent of healthcare organizations reported that their medical devices were hit by malware or ransomware.  Many experts are also projecting that more cyber-attackers will target devices in 2019.

The FDA has recognized cybersecurity risk related to medical devices for quite some time, and has taken this step to further protect patients from such risks.  Other organizations have also taken aim at this issue, such as the National Institute of Standards and Technology (NIST) issuing guidance related to telehealth monitoring devices.  However, medical device manufacturers may continue to struggle to address these risks in design, development and implementation.  As a result, with Internet of Things (IoT)-enabled device innovation continuing to expand and the expectation of new threats, it is imperative that medical device consumers and manufacturers keep pace to ensure device network security.

There are several complexities that exist relative to securing medical devices. First, many devices no longer function as stand-alone components in healthcare settings as they are being integrated into the health care IoT.  Second, an increasing number of medical devices are network-connected and transmitting sensitive patient data through other wired or wireless components.  These two factors create quality improvements, convenience and flexibility to physicians and patients, but they can also introduce new security vulnerabilities that could adversely affect clinical operations as well as put patients at risk.

The FDA guidance addresses a number of key areas of risk.  In particular, the guidance recognized vulnerabilities stemming from insufficient access control safeguards medical devices.  For instance, administrators often assign the same password to multiple devices, which could provide unauthorized access to each device and its data.  Additionally, the FDA noted that data transmitted through the devices is not always encrypted, which could allow unauthorized individuals to intercept and even modify clinical information impacting patients’ privacy and/or safety.  Finally, a number of devices are vulnerable to malware without the ability to apply security patches.

To reduce risk, there are several measures that can be implemented to enhance device security.   For instance, hospitals and health systems should include medical devices in security risk analyses and risk management plans. Additionally, organizations should thoroughly evaluate security risks related to devices and vendors before purchasing devices (e.g. request disclosure of device cybersecurity properties).  As for device manufacturers, enhanced security systems should be baked into devices to monitor device networks and ensure device authorization is limited to assigned authorized users.

EBG will continue to keep an eye on how the industry reacts and implements the FDA’s guidance over time.


Brian Hedgeman


Alaap B. Shah

On November 1, 2018, the Office of the Inspector General (“OIG”) for the U.S. Department of Health and Human Services (“HHS”) published an audit report finding that the U.S. Food and Drug Administration’s (“FDA”) policies and procedures were “deficient for addressing medical device cybersecurity compromises.” (A copy of OIG’s complete report is available here and Report in Brief is available here.) Specifically, the OIG found that FDA’s policies and procedures were “insufficient for handling postmarket medical device cybersecurity events” and that FDA had not adequately tested its ability to respond to emergencies resulting from cybersecurity events in medical devices. Although the OIG report “did not identify evidence that FDA mismanaged or responded untimely to a reported medical device cybersecurity event,” it noted that “existing policies and procedures did not include effective practices for responding to these events.”

Citing cybersecurity of medical devices as a top management challenge for HHS, OIG conducted an audit to evaluate FDA’s plans and processes for timely communicating and addressing cybersecurity compromises in the medical device postmarket phase. Based on OIG’s audit of certain FDA internal policies, procedures, and website, as well as interviews with FDA staff, OIG recommended that FDA take the following actions: (i) continually assess the cybersecurity risks to medical devices and update its plans and strategies; (ii) establish written procedures and practices for securely sharing sensitive information about cybersecurity events with key stakeholders; (iii) enter into a formal agreement with federal agency partners; and (iv) establish and maintain procedures for handling recalls of medical devices vulnerable to cybersecurity threats. Although the OIG acknowledged that FDA has recently implemented some of its initial recommendations, it emphasized that its findings and recommendations with regard to FDA’s cybersecurity policies and procedures remain valid.

On the same date OIG published its report, FDA’s Suzanne B. Schwartz, M.D., M.B.A., published a post on FDA Voices asserting that the OIG report is an incomplete and inaccurate picture of FDA’s oversight of medical device cybersecurity. The post addresses FDA’s ongoing efforts to improve medical device cybersecurity over the past five years, including entering into a memorandum of agreement between FDA and the Department of Homeland Security (“DHS”) and publishing a new premarket cybersecurity guidance update in October 2018, which we wrote about in a previous blog here. FDA’s post also highlights FDA’s other partnerships with industry that aim to increase awareness of cybersecurity vulnerabilities and related concerns.

FDA reiterated that its regulatory approach to cybersecurity threats “is not static,” and reconfirmed its commitment to “work with the medical device industry and other stakeholders to proactively address emerging cybersecurity threats to medical devices in a way that puts patient safety first.” FDA has announced that it will hold a public Workshop on January 29-30, 2019 to discuss the newly released draft guidance on cybersecurity in premarket submissions. Instructions for registration are available on FDA’s website here.

In response to the OIG’s report, FDA will likely continue to develop new cybersecurity policies, initiatives, and guidance. Stakeholders in the medical device industry should monitor these developments and be prepared to address any such changes in policy or regulation. Meanwhile, regulated industry should consider reviewing FDA’s current cybersecurity guidance documents and assess whether its internal controls, quality systems, policies, or procedures adequately address potential cybersecurity risks or threats or could be improved.

EBG will continue to monitor all developments in FDA’s regulation of and policies related to medical device cybersecurity.

Recent comments by the Federal Trade Commission (FTC) Commissioner Rohit Chopra should have companies on notice for increased enforcement actions across the board. During the “Privacy. Security. Risk.” Conference in Texas last week, Chopra made comments regarding his views on increasing enforcement, including the imposition of greater civil monetary penalties. “I’ve already raised concerns about settlements we do with no monetary penalties. I want to see monetary consequences for egregious breaking of the law” said Chopra as reported by the IAPP during a live podcast taping. Chopra also stated that he was troubled by current federal enforcement action in the United States, the answer to which appears in part to come with heftier fines.

While the FTC hopes to have a bigger bite, it appears that Congressional action, or lack thereof, is in many ways muzzling the agency. During a House Subcommittee hearing in July, FTC officials indicated that while they were aggressively pursuing action regarding data and privacy security, they also said that their hands were tied in regard to bringing more aggressive enforcement. As stated by Chairman Joe Simmons, “In my view, we need more authority. I support data security legislation that would give us three things: (1) the ability to seek civil penalties to effectively deter unlawful conduct, (2) jurisdiction over non-profits and common carriers, and (3) the authority to issue implementing rules under the Administrative Procedure Act. And we should consider additional privacy authority as well….” In part, Chairman Simmons may be referencing Congress’s failure to pass a comprehensive data protection law, particularly in the shadow of the European Union’s GDPR standards, which are continuing to impact American companies.

These comments come at a time where companies face ever increasing risk as the economy becomes more and more data-centric. Across the country, companies and their boards are faced with an ever more complex business decision on how to make cyber-security make business sense. On the one hand, investing in a robust cyber-security program, both in terms of designing a compliance strategy and investing in technology, is balanced with the risk and cost of a data breach. While the risks appear to be increasing, the cost of such a breach may also be increasing as well. In addition to a loss of revenue due to a drop in consumer confidence, Chairman Simmons and Commissioner Chopra’s comments should make companies aware that enforcement and increased civil monetary penalties may also be more of a threat towards business’s bottom lines.

The FDA issued a new Draft Guidance today to ensure medical devices – an increasing potential target for hackers – are better protected from unauthorized digital access.

According to the FDA’s draft guidance issued today, “Cybersecurity incidents have rendered medical devices and hospital networks inoperable, disrupting the delivery of patient care across healthcare facilities in the US and globally. Such cyberattacks and exploits can delay diagnoses and/or treatment and may lead to patient harm.”

Under the proposed draft guidance manufacturers will be required to better protect their devices in a more uniform manner as prescribed by the FDA. The new pre-market submission proposals are designed to help guide the industry in designing these digital safety mechanisms from the beginning of product design and development.

The New Guidance covers Premarket Notification (510(k)) submissions (including Traditional, Special, and Abbreviated); De Novo requests; Premarket Approval Applications (PMAs); Product Development Protocols (PDPs) that contain software (including firmware) or programmable logic; as well as software that is a medical device.

While manufacturers are required under Quality System Regulations to establish and maintain procedures for validating the devices design including software validation and risk analysis, FDA is recommending validation include design controls to ensure medical device cybersecurity and maintain medical device safety and effectiveness. Including these design controls may make it easier for FDA to “find your device meets its applicable statutory standard for premarket review.”

The recommendations in the newly released Draft Guidance describe using a more risk-based approach to the design and development of appropriate cybersecurity protections. The FDA wants manufacturers to design programs to follow their devices throughout the device lifecycle, monitor new and potential threats, and issue cybersecurity updates to thwart new attempts at unauthorized digital access of the devices.

Because devices that connect to the internet or wirelessly to other devices pose a new and larger threat to cybersecurity, the FDA is requiring a Cybersecurity Bill of Materials be included in the manufacturers filing to identify key components and accessories that could render the device vulnerable to “hacking”. The FDA is creating a new Tier 1 level of standards for these devices to ensure greater security than Tier 2 devices (those that are not wirelessly or internet connected).

Design controls should include appropriate authorization such as ID’s, passwords, time limited sessions with auto logout, layered authorization (i.e. patient, healthcare professional, technician) should now be used in the design of these devices. Authentication and authorization of critical safety commands will be considered in new submissions. In addition, proper labeling to warn patients and providers of the cyber security risks involved in these devices is essential.

For an updated list of FDA recognized consensus standards the Agency recommends that you refer to the FDA Recognized Consensus Standards Database.

 

 

 

The National Institute of Standards and Technology (“NIST) has announced that it will be seeking industry input on developing “use cases” for its framework of cybersecurity standards related to patient imaging devices. NIST, a component of the Department of Commerce, is the agency assigned to the development and promulgation of policies, guidelines and regulations dealing with cybersecurity standards and best practices.  NIST claims that its cybersecurity program promotes innovation and competitiveness by advancing measurement science, standards, and related technology in ways that enhance economic security and quality of life. Its standards and best practices address interoperability, usability and privacy continues to be critical for the nation. NIST’s latest announcement is directed at eventually providing security guidance for the healthcare sector’s most common uses of data, inasmuch as that industry has increasingly come under attack.

The current announcement is reflective of the interest of NIST and the Food & Drug Administration (“FDA”), the primary regulatory agency for medical devices, within the so-called Internet of Things (“IoT”).  Thus, NIST, through its National Cybersecurity Center of Excellence, will accept proposals up to  June 8, 2018, for “products and technical expertise” relevant to the creation of guidelines for securing data used by Picture Archiving and Communication Systems (“PACS”). NIST will attempt to harmonize the requirements for patient imaging devices with NIST’s overall cybersecurity framework.

The proposed project will examine the specific uses and regulatory requirements for patient imaging devices, and how those varying considerations apply to the use of the NIST cybersecurity framework. As the NIST project summary notes PACS are regulated by the FDA as “class II” devices that provide one or more functions related to the “acceptance, transfer, display, storage, and digital processing of medical images.”  These devices, which can be found in virtually every hospital, are not only vulnerable to cyber-attack in and of themselves, but NIST sees them as a “pivot point into an integrated healthcare information system.”

The current imaging device project follows last year’s release of draft guidelines for wireless infusion pumps, and evidences the government’s continuing concern, not only with the security of the IoT, but with specific reference to the vulnerable health care sector.

Epstein Becker Green routinely deals with questions related to medical device regulation and cybersecurity. For further information, you can contact Stuart Gerson, Adam Solander, Bradley Merrill Thompson or James Boiani.

Last week’s “WannaCry” worldwide Ransomware attack was particularly targeted against international health organizations. Though the attack was thwarted not without a little good luck and less financial loss that might have been predicted, it unsurprisingly triggered responses from U.S. government agencies including the Department of Homeland Security (DHS) and, with specific reference to health care providers, the Office of Civil Rights (OCR) of the Department of Health & Human Services (HHS). It also is no surprise that these government agencies took a carrot and stick approach – speaking about cooperation on one hand and enforcement (by OCR) on the other.

On the cooperative side, DHS and HHS have sought to work with the tech sector to employ cybersecurity best practices to address the ransomware threat, now the most common problem faced across the cyber universe but especially in health care. DHS has opined that “Individual users are often the first line of defense against this and other threats, and we encourage all Americans to update your operating systems and implement vigorous cybersecurity practices including installation of the latest patches and avoiding phishing efforts that can implant ransomware to lock down a system. Among the recommended best practices include employee training to avoid clicking on unfamiliar links and files in emails, and to backing up data to prevent possible loss. Beyond those somewhat simplistic suggestions, one detects a decided trend towards to adoption of the voluntary framework of cybersecurity standards issued by the National Institute of Standards and Technology (NIST), which was issued in 2014 and is in the process of being updated per public comments and meetings.  This also is consistent with the recently issued Executive Order that mandates federal department compliance to the same standards suggested for the private sector, particularly the NIST framework.

The OCR enforcement component is more problematic.  On May 17, 2017, Iliana Peters, a HIPAA compliance and enforcement official at OCR, announced at a Georgetown University Law Center cybersecurity conference that OCR will “presume a breach has occurred” when an HIPAA covered entity or associate has experienced a ransomware attack, due to the nature of how ransomware attacks work. This is somewhat at odds with the way that ransomware actually works. Ransomware generally is a form of blackmail where a Trojan will deprive a data owner of access to its own data unless a ransom is paid (often by Bitcoin or another block chain currency). OCR’s presumption can be overcome especially if health care data were encrypted prior to the incident (and presumably that would include data at rest). HHS’s ransomware guide provides that:

“Unless the covered entity or business associate can demonstrate that there is a ‘low probability that the PHI has been compromised,’ based on the factors set forth in the Breach Notification Rule, a breach of PHI is presumed to have occurred. … The entity must then comply with the applicable breach notification provisions, including notification to affected individuals without unreasonable delay, to the Secretary of HHS, and to the media (for breaches affecting over 500 individuals) in accordance with HIPAA breach notification requirements.”

Thus, if there is anything to take away from this, it is to encrypt PHI – period.

OCR offers to work with the private sector to provide technical assistance.  This might be useful to very small, unsophisticated  organizations.  Larger private sector entities arguably have resources and technical skills that surpass those of the government.  Indeed, the President’s Executive Order recognizes this.

We at Epstein Becker Green will have more to say about the ransomware threat and other cyber security vectors affecting the health care space. Expect a webinar and other publications like this one in the near future.

Surprisingly amidst the Federal Bureau of Investigation (FBI) uproar, President Trump today signed an executive order addressing cybersecurity for the federal government and critical infrastructure, along with international coordination and cyber deterrence. The substance of the order, which is about to be made public, comes from various press releases and interviews with administration officials. The order is composed of three sections on cybersecurity and IT modernization within the federal government, protecting critical infrastructure, and establishing a cyber deterrence policy and coordinating internationally on cyber issues. In directing cabinet agencies to protect critical infrastructure, the order references the Obama administration’s “section 9” list of most critical entities, which already has prompted questions from industry.  Specifically, the order directs the Commerce Department and the Department of Homeland Security to coordinate an effort to reduce botnet cyber-attacks through a voluntary partnership with industry. This effort mirrors health industry association comments to Commerce’s National Institute of Standards and Technology (NIST), which next week will have an open forum to address the many comments made to its  rulemaking proposals. Interestingly, the Order directs the cabinet agencies to coordinate their own efforts with NIST.  The White House staff has been quoted as saying that “it is about time” the federal government was held to the same standard as private industry in addressing cybersecurity. Consistent with Industry requests, the framework is a voluntary tool actually developed in collaboration with industry, which argues that flexibility is required because policies must be adapted to the needs of different entities.

On the health care cyber front, it is interesting to note that James Comey’s last formal speech was given on May 8th to the American Hospital Association in which he raised concerns about the ability of the FBI to combat cyber-attacks and urged cooperation with hospitals and health systems not to get patient records but “fingerprints of digital intrusion.” I note that this is the point of the work of InfraGard, a cooperative effort between industry and the FBI, and is consistent with the public proposals of the Information Sharing and Analysis Organization Standards Organization (ISAO-SO), established by executive order.  Further information regarding those efforts, in which this author is active, can be provided at sgerson@ebglaw.com.

Comey’s abrupt departure suggests that his statements may quickly become passing memories, but the cooperative tone struck is more than a little inconsistent with proposals, for example, from the Department of Health & Human Services’ Office of Civil Rights (OCR), the enforcement agency for Health Insurance Portability and Accountability Act (HIPAA) matters, and from the Federal Trade Commission (FTC), which soon may inherit enhanced powers as the Federa l Communications Commission is attempting to leave the cyber security enforcement field.  Both the Office of Human Rights and the FTC stress enforcement as the optimal mode of gaining cyber compliance.

In the coming days, you may expect further analysis by Epstein Becker Green of OCR’s developing enforcement stance and other emergent government policies in the wake of the new Executive Order.

Executive Order Delay Trumps Administration Policy Development

President Trump’s first hundred days did not produce the event that most people in the cybersecurity community expected – a Presidential Executive Order supplanting or supplementing the Obama administration’s cyber policy – but that doesn’t mean that this period has been uneventful, particularly for those in the health care space.

The events of the period have cautioned us not to look for an imminent Executive Order. While White House cybersecurity coordinator Robert Joyce recently stated that a forthcoming executive order will reflect the Trump administration’s focus on improving the security of federal networks, protecting critical infrastructure, and establishing a global cyber strategy based on international law and deterrence, other policy demands have intruded. Indeed as the 100-day mark approached, President Trump announced that he has charged his son-in-law, Jared Kushner, with developing a strategy for “innovation” and modernizing the government’s information technology networks. This is further complicating an already arduous process for drafting the long-awaited executive order on cybersecurity, sources and administration officials say.

The Importance of NIST Has Been Manifested Throughout the Hundred Days

The expected cyber order likely will direct federal agencies to assess risks to the government and critical infrastructure by using the framework of cybersecurity standards issued by the National Institute of Standards and Technology, a component of the Department of Commerce.

The NIST framework, which was developed with heavy industry input and released in 2014, was intended as a voluntary process for organizations to manage cybersecurity risks. It is not unlikely that regulatory agencies, including the Office of Civil Rights of the Department of Health and Human Services, the enforcement agency for HIPAA, will mandate the NIST framework, either overtly or by implication, as a compliance hallmark and possible defense against sanctions.

NIST has posted online the extensive public comments on its proposed update to the federal framework of cybersecurity standards that includes new provisions on metrics and supply chain risk management. The comments are part of an ongoing effort to further revise the cybersecurity framework. NIST will host a public workshop on May 16-17, 2017

Health Industry Groups Are Urging NIST to Set up a ‘Common’ Framework for Cybersecurity Compliance

Various health care industry organizations including the College of Healthcare Information Management Executives and the Association for Executives in Healthcare Information Security have asked NIST to help the industry develop a “common” approach for determining compliance with numerous requirements for protecting patient data. Looking for a common security standard for compliance purposes, commenters also argue that the multiplicity of requirements for handling patient data is driving up healthcare costs. Thus, the groups urge NIST to work with the Department of Health and Human Services and the Food and Drug Administration “to push for a consistent standard” on cybersecurity. One expects this effort, given strong voice in the First Hundred Days, to succeed.

The Federal Trade Commission is Emerging as the Pre-eminent Enforcement Agency for Data Security and Privacy

With administration approval, the Federal Communications Commission is about to release today a regulatory proposal to reverse Obama-era rules for the internet that is intended to re-establish the Federal Trade Commission as the pre-eminent regulatory agency for consumer data security and privacy. In repealing the Obama’s “net neutrality” order, ending common carrier treatment for ISP and their concomitant consumer privacy and security rules adopted by the FCC, the result would be, according to FCC Chairman Pai, to “restore FTC to police privacy practices” on the internet in the same way that it did prior to 2015. Federal Trade Commission authority, especially with regard to health care, is not without question, especially considering that the FTC’s enforcement action against LabMD is still pending decision in the 9th Circuit. However, the FTC has settled an increasing number of the largest data breach cases The Federal Trade Commission’s acting bureau chief for consumer protection, Thomas Pahl, this week warned telecom companies against trying to take advantage of any perceived regulatory gap if Congress rolls back the Federal Communications Commission’s recently approved privacy and security rules for internet providers.

OCR Isn’t Abandoning the Field; Neither is DoJ

While there have been no signal actions during the First Hundred Days in either agency. The career leadership of both has signaled their intentions not to make any major changes in enforcement policy.  OCR is considering expanding its policies with respect to overseeing compliance programs and extending that oversight to the conduct off Boards of Directors.

The Supreme Court Reaches Nine

Many would argue that the most important, or at least most durable, accomplishment of the Trump Administration to date is the nomination and confirmation of Neil Gorsuch to the Supreme Court. Justice Gorsuch is a conservative in the Scalia mold and is expected to case a critical eye on agency regulatory actions. There is no cybersecurity matter currently on the Supreme Court’s docket, but there will be as the actions and regulations of agencies like the FTC, FCC and DHHS are challenged.

The Food and Drug Administration (“FDA”) recently announced that it will be hosting a public workshop on October 21 and 22, 2014, in Arlington, Virginia, entitled “Collaborative Approaches for Medical Device and Healthcare Cybersecurity.”

Officials from FDA, the Department of Health and Human Services (“HHS”), and the Department of Homeland Security (“DHS”) will bring together medical device manufacturers, insurers, cybersecurity researchers, trade organizations, government officials, and other stakeholders to discuss the numerous challenges faced in medical device cybersecurity.

CDRH OFFICIAL: BE AWARE OF DEVICE RISKS

On September 23 and 24, 2014, the National Institute of Standards and Technology (“NIST”) and the Department of Health and Human Services Office of Civil Rights (“HHS OCR”) hosted their annual HIPAA conference “Safeguarding Health Information: Building Assurance through HIPAA Security

In her presentation “Medical Devices: A Practical Guide for Securing Patient Data“, Dr. Schwartz, from the FDA Center for Device and Radiological Health, emphasized the need for a collaborative approach in the medical device ecosystem to ensure security. Because most of the millions of hospital discharges, hospital outpatient visits, physician office visits and prescriptions in the US involve networked medical devices, Dr. Schwartz indicated that securing these devices is of the utmost importance for both regulatory and practical purposes.

MEDICAL DEVICES HAVE INHERENT VULNERABILITIES

Dr. Schwartz noted that as medical devices become increasingly connected through wireless and wired networks, it is critical to ensure adequate controls are in place on the network. Computers, wireless and mobile devices, and the medical devices themselves can be infected or disabled with malware. Security vulnerabilities also exist in the form of sharing of passwords, lack of proper training for personnel, and failure to update and patch software on the network.

Several medical devices have already been compromised in the past few years. For example, researchers demonstrated in 2013 that about 300 medical devices from around 40 vendors contained hard-coded passwords, making them highly vulnerable. In 2011, a hacker presented his findings related to his own insulin pump, which could easily be compromised and the pump’s levels remotely changed to a lethal dose.

FDA OFFERS STANDARDS, GUIDANCE

FDA has recognized standards for cybersecurity and interoperability as well as wireless technology in medical devices. Additionally, on October 2, FDA released final guidance, on the content of premarket submissions for medical device cybersecurity.  Those of you who are familiar with the draft guidance should note that the final guidance is substantially similar to the draft guidance with some additional emphasis on balance, emphasizing that security should not unreasonably limit the ability to use a device in emergency situations.

For those who are not familiar with the draft guidance, the final guidance describes the information that manufacturers should include in their premarket submission.  It recommends medical device manufacturers consider the following as part of their cybersecurity activities:

  • Identify and protect by limiting access to trusted users and ensuring trusted content;
  • Implement features to detect security compromises
  • Inform the end user about the appropriate action to take if a security compromise is detected
  • Protect critical functions, even in the event of a security compromise

Device stakeholders would do well to review these documents and ensure that they understand the steps they should take to meet these standards and comply with the HIPAA Security Rule.

WHAT STAKEHOLDERS SHOULD DO

There are a number of good steps which can be taken to reduce risk. Properly training all personnel is critical to avoid loss of devices, phishing attacks, and more. Ensuring that software is always the most up-to-date version is an easy and important measure to improve security. Additionally, segregating network functions will ensure that any compromise will not affect the entire universe of networked devices. New devices and software should be thoroughly inspected for potential security vulnerabilities before adding them to the network.

On top of those steps, healthcare entities should conduct regular risk assessments and network security audits. Crafting policies to comply with standards such as ISO-27001, COBIT 5, or the HITRUST Common Security Framework is a must.