Ensuring Security, Privacy, and Compliance in Healthcare IT - Redspin Information Security
Ensuring security, privacy, and
compliance while creating
value with healthcare IT
A step by step approach
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www.redspin.com White Paper
Ensuring security, privacy, and compliance
while creating value with healthcare IT
From electronic health record adoption to clinical
A step by step approach to meeting security,
workflow automation, healthcare increasingly runs
privacy, and compliance goals through a focus
on information. Yet, healthcare has traditionally
on value creation.
lagged other industry segments in terms of IT
spending. As a percent of revenue, IT spending
Spiraling costs and a lack of global competitive- represents just over 5% for the healthcare industry
ness are often cited as major problems with the segment versus 11% for financial services (For-
U.S. healthcare system. Information technology rester Research). More importantly IT spending
can be a significant part of the solution to these in healthcare has not been aligned with achieving
problems. In fact, industry leaders and the gov- objectives. Given the rising demands for overall
ernment sector have begun to focus resources, transformation of the healthcare industry and the
management attention, and funding towards IT competitive pressures on U.S. provider organiza-
investments. Yet historically, IT has been viewed tions, healthcare urgently needs the improvements
as a cost center rather than as an investment. As IT can enable. Information security must play a
an element of that cost center, spending on IT central role in this transformation both in terms of
security, privacy, and compliance has been typi- ensuring patient trust through proper use of their
cally budgeted at the minimum level necessary to data and protecting the business from threats rang-
meet regulatory requirements. A new perspective ing from cyber crime to brand damage associated
is required, where investing in IT is understood to with data breaches.
create value by increasing competiveness, lowering
costs, and increasing the quality of patient care. IT Value Oriented, Performance Driven
thus becomes a large part of the solution to the Fortunately, this transition to value-oriented, per-
problems facing the healthcare industry. formance driven healthcare is underway in several
leading providers such as Kaiser Permanente, Part-
This paper examines a general process for manag- ners Healthcare System and Geisinger. A common
ing healthcare IT investments and specifically out- denominator among these companies is that IT
lines a step by step approach to meeting security, and the information security program are viewed
privacy, and compliance goals through a focus on as creating value rather than cost centers. From a
value creation and risk management. Information process perspective these leaders have also devel-
security programs in the healthcare sector have of- oped similar methods for aligning IT investments
ten been driven by reactive approaches and ad hoc with value to the business. This involves defining a
compliance oriented processes. These approaches set of observable, quantifiable operational metrics.
view “success” as avoiding security incidents and Broad categories include benefits to patient safety,
passing compliance audits with the minimum quality of care, staff productivity, employee satis-
amount of investment. We will examine why this faction, revenue enhancement, and cost optimiza-
approach is unsustainable and show how it be- tion. In this manner IT investments are evaluated
lies widely-accepted risk management principles. in terms of how well they help the organization
Instead, we will offer a results-oriented alterna- meet business objectives. Another critical common
tive that ensures security, compliance, and privacy factor in these organizations is a system of risk
programs that support the overall healthcare IT management for continuously optimizing security,
mission of creating value and meeting business privacy, and compliance initiatives. Throughout the
objectives. rest of this paper we will discuss the step by step
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process of deploying a successful information risk Organizing For Performance (Figure 1)
The major steps associated with a successful infor-
mation risk management program are as follows:
1. Organizing for performance
2. Assessing risk
3. Decision analysis
4. Policy implementation
5. Measuring program effectiveness
6. Repeat steps 2-5, adjust the organization
defined in step 1 to evolving business re-
The objective of the information risk management
The first step in the process involves organizing program is to minimize risk to information that
for performance. There are two critical compo- is critical to the business while enabling business
nents for success. The first component is execu- goals. The primary interactions in this area are
tive sponsorship. Executive sponsorship is not with the line of business, finance, and legal teams.
a passive role. The executive sponsor is typically The security team must codify the net results in
the CIO or CISO and is responsible for funding, terms of policy that will drive operational as well
authority, and support of the information risk as quality and performance management decisions.
management program. This role also serves as Information security management is owned by the
the final escalation point to define acceptable risk security team but interacts and primarily leverages
to the business. The second critical component operations, IT, and HR. Information generated
for success is integration of the information risk at this point contributes to the overall picture of
management program with the rest of the orga- situational awareness that guides both the business
nization. A program that does not leverage other and the information risk management program.
functional units will have difficultly aligning with The security relevant aspects of quality and perfor-
business goals and ultimately fail. mance management for the business are owned by
the security team but must work with the audit, de-
A successful organizational structure for carrying velopment, and QA teams. This function generates
out the step by step information risk management the reporting metrics (e.g. compliance to internal
plan outlined above is shown in Figure 1. policies and regulatory requirements) that drive
decisions for the business and the security team
as well as contributing to the overall situational
awareness picture. The overall output of this cycle
is not simply to protect information but to allow
better decisions to be made that drive the business
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With this organization in place the information PHI/PII Risk Indication (Figure 2)
risk management program can be set in motion.
Before describing the process in detail it is useful
to consider alternative approaches. With pressure
to meet the more stringent regulatory requirements
imposed by the HITECH act, urgent deadlines to
meet meaningful use requirements, and the need
to react to day to day incidents, it is easy for a
program to become derailed. Let’s consider the re-
quirements required to comply with the HITECH
act. Organizations must do the following:
• Implement a data classification policy that
describes the processes used to identify, classify,
store, secure, and monitor access to PHI data.
• Implement a process to detect a potential data
breach and carry out an incident response plan.
• Implement a notification process to inform Developing a broader view of risk to the business
affected parties after a discovery of a breach allows the information risk management team to
of security to PHI without unrea-sonable delay. avoid acting narrowly. For example, rather than a
siloed effort to develop policies and implement
• Implement policies, processes, and procedures controls to comply with the HITECH Act, a pro-
for security awareness and training. gram can be put in place that addresses the unified
regulatory requirements associated with PHI/PII
• Encrypt PHI data – at rest and in transit. data.
Immediately launching an effort to address these Now let’s examine each of the steps to carry out
requirements is tempting, but fraught with peril. the information risk management program. The
Many HIPAA security programs focused on creat- continuous nature of this process is illustrated in
ing policies and procedures as a starting point. Figure 3.
Frequently, there was a disconnection between
policies and actual technical and procedural safe- Risk Management Process (Figure 3)
guards. Further, there is not a clear understanding
of the broader risk picture and integration with the
business context. A more informed view is shown
in Figure 2.
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Step 1. Assess Risk a. Ensure that policy specifications are enforce-
The first step in the process involves identification able.
and prioritization of risks to the business.
b. Apply a comprehensive approach that inte-
a. Plan data gathering. Identify key success grates process automation, people, and tech-
factors and preparation guidance. nology in the mitigation solution.
b. Gather risk data. Outline the data collection c. Focus on defense in depth by coordinating
process and analysis. application, system, data, and network controls
to meet business objectives.
c. Prioritize risks. Use qualitative and quantitative
risk analysis to drive prioritization. d. Communicate policies and control responsibili-
ties throughout the organization.
Step 2. Decision Analysis
The second step covers the processes for evaluat- Step 4. Measure Effectiveness
ing requirements, understanding possible solutions, The fourth step consists of developing and dis-
selecting controls, estimating costs, and choosing seminating reports as well as providing managment
the most effective mitigation strategy. a dashboard to understand program effectiveness.
a. Define functional requirements to mitigate a. Develop and continuously update a manage
risks. ment dashboard that summarizes the organiza-
tion’s risk profile.
b. Outline possible control solutions. Keep in
mind that these include not only technical con- b. Report on changes under consideration and
trols but people-driven processes (e.g., separa- summarize changes that are underway.
tion of duties) and service level agreements.
c. Communicate the effectiveness of the control
c. Estimate risk reduction. Understand the solutions in mitigating risk.
probability of risks and the impact of reduced
exposure. d. Report on the existing environment in terms
of threats, vulnerabilities and risk profile.
d. Estimate solution cost. Reflect direct and
indirect costs associated with mitigation Key Success Factors
solutions. As noted earlier a major element contributing
to the success of an information risk manage-
e. Choose mitigation strategy. Complete a cost- ment program is involvement of functional units
benefit analysis to identify the most effective throughout the organization. The information risk
mitigation solution. management team needs to take responsibility for
educating the organization on the process and de-
Step 3. Policy Implementation veloping the thorough understanding of risk that
The third step addresses policy implementation will allow the business to take specific action when
and the acquisition and deployment of controls to managing it.
carry out the policy.
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An effective method to get this process underway • Critical - Corrective measures are required im-
is to view risk across four simple categories. This mediately.
provides a straightforward way to clarify trad-
eoffs and make decisions. These categories can be • High - Strong need for corrective measures.
thought of as the four A’s: An action plan must be put in place as soon as
Availability: This means keeping the systems run- • Medium - Corrective actions are needed
ning. IT needs to communicate regularly to execu- and a plan must be developed to incorporate
tive staff on the availability risk to major business these actions within a reasonable period of time.
processes and ensure there is a business continuity
plan in case of failure. • Low - Management must determine whether
corrective actions are required, or decide to ac-
Access: This is defined as ensuring access to cept the risk.
systems and data. IT is responsible for provid-
ing the right people with the access they need and • Informational - The issue does not indicate
ensuring that sensitive information is not misused. a material policy violation but is something
The IT organization must regularly discuss risks for management to consider for enhancing the
associated with data loss, privacy violations, and overall security posture.
Drive these definitions into risk mitigation pro-
Accuracy: This means providing complete, timely grams, policy specifications and controls.
and correct information that meets the require-
ments of customers, suppliers, regulators and Next, everyone in the organization needs a clear
management. Compliance with HIPAA/HITECH and consistent definition of risk. In this context,
and Sarbanes-Oxley are common sources of ac- risk is the probability of a vulnerability being ex-
curacy risk for enterprises in the United States. ploited in the current environment, leading to a
IT should review with management the sources of degree of loss of confidentiality, integrity or avail-
accuracy risk (and risk mitigation programs) such ability of an asset. The diagram shown in Figure
as the inability to get an accurate, consistent view 4 illustrates the relationships of each element of
of patient records or clinical workflow effective- risk.
Component of Risk (Figure 4)
Agility: This is defined as the ability to make the
necessary business changes with appropriate
cost and speed. A specific example of agil-
ity risk would be the delay or cancellation of
a merger because of the risk of integrating IT
systems. The IT organization needs to dis-
cuss these risks so that management can make
informed decisions and not hedge their bets be-
cause they don’t believe IT can deliver on time.
Another area to look at is consistent usage of
risk severity levels and the associated actions. At
Redspin we use five levels:
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To illustrate the usage of a risk statement in prac- strongly with management. However, such a pro-
tice let’s look at an example focusing on risk to cess is resource intensive and thus more expensive
PHI data. so broad based coverage is challenging. Therefore,
focusing on high impact areas with quantitative
The assets (what you are trying to protect is PHI) methods and driving coverage with qualitative
approaches tends to produce the best results.
• You need to know where it is, how it is used,
and how it is transported over the network. A final consideration in terms of key success
factors is the timing for repeating the process.
The threats (what are you afraid of happening) Each cycle starts with a new risk assessment. The
frequency will vary from organization to organiza-
• Sophisticated cybercriminals stealing account tion. Many companies find that annual recurren-
credentials, credit card records, or medical ceis sufficient so long as the information security
history to file false claims. team is proactively monitoring for new threats,
vulnerabilities, and assets.
• Hackers using application attacks to gain access
to database records. In summary, you can expect investment in an
information risk management program to bring
• Insiders gathering inappropriate data through important business benefits. Some of these include
misconfigured access control. the following:
The vulnerabilities (how could the threat occur) • Risk reduction allows deployment of new busi-
ness processes that were not previously possible.
• Targeted social engineering attacks; malware
exploiting Adobe .pdf and MS office .doc vul- • Confidence in brand protection can result in
nerabilities new revenue generating programs.
• Application vulnerabilities (e.g., SQL injection,
command injection) • Trust in service availability means that existing
programs can generate more revenue and more
• Misconfigured database access controls profitably.
Current mitigation (what is currently reducing • Confidence in risk mitigation efforts ranging
the risk) from technical controls to effective service level
agreements decrease program launch time.
• Clear guidance on security requirements associ-
• Technology ated with new business unit projects accelerates
time to revenue.
Another key success factor is development of an
effective methodology for risk assessment. There
are many different approaches but most are quali-
tative or quantitative methods or a combination of
the two. A quantitative approach allows risk to be
expressed with financial values and thus resonates
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