Healthcare Compliance and Policy Development 101
Author Jake Yates at Healthcare Compliance pros
Custom healthcare compliance policy development helps
organizations turn regulatory requirements into written instructions reflecting
how their teams actually work. For organizations with limited internal
resources, outsourcing can provide focused support without adding another
full-time position.
However, purchasing a group of generic policy documents is not
the same as implementing a compliance program. The Office of Inspector
General's (OIG) voluntary General Compliance Program Guidance (GCPG)[1]
identifies written policies and procedures as one element of a broader program which
also includes leadership, training, reporting, monitoring, enforcement, and
corrective action. Effective documentation must connect those activities and
not just sit untouched in a policy library.
This healthcare compliance policy blog article will explain
what to evaluate before hiring a compliance vendor, how to compare proposals,
and what custom policy development should accomplish.
Can I outsource healthcare compliance policy development?
Yes! You can engage an outside compliance vendor or
consultant to assess, draft, customize, and maintain your healthcare compliance
policies. However, your policies should not be generic and
non-customizable. The engagement should clearly distinguish the vendor or
consultant's responsibilities from your organization's responsibilities for
approval, implementation, and oversight.
Outside assistance does not replace internal
accountability! For example, the HIPAA Security Rule requires regulated
entities to adopt "reasonable and appropriate" policies and procedures and
evaluate how effectively their safeguards meet applicable requirements.[2]
Having a consultant prepare the documents does not eliminate those obligations.
Outsourcing may be worth considering when you are opening or acquiring a
facility, adding services, addressing audit findings, consolidating multiple
policy libraries, or working through a substantial backlog.
The most productive arrangement combines external regulatory
knowledge with internal operational knowledge. Your compliance vendor or
consultant can help interpret requirements and structure documentation while you
expound and explain how your workflows, staffing, technology, and approval
processes support compliance with the regulations. Neither perspective should
be missing.
How much does custom compliance policy development cost?
The cost of policy development services can depend on the
work required. A reliable estimate should follow an assessment of your existing
documentation, organizational structure, regulatory exposure, and desired
deliverables.
Rather than a broad price range, ask for a written proposal explaining
exactly what you are purchasing. A single policy revision is not comparable to
a multistate policy library with stakeholder interviews, implementation
materials, and ongoing maintenance. Ask whether the proposal uses per-policy
pricing, a fixed project fee, hourly billing, or a recurring service
arrangement. Also clarify whether revisions, meetings, legal review, training
materials, and future updates are included or billed separately. The most
important cost drivers to discuss are the number of policies, the amount of
original drafting, the number of locations and jurisdictions, and the
complexity of your operations. Existing policies may reduce drafting work, but
only if they remain accurate and usable.
Evaluate the value, not just the document count. A
lower price package may require substantial internal rewriting but if no one
has the time to do the internal rewrite, you may be doing even more work on the
policy project. However, in that case a more comprehensive engagement may
reduce that burden, but savings should be assessed against your actual staffing
costs and the vendor or consultant's defined scope.
How often should healthcare compliance policies be updated?
OIG recommends reviewing policies and procedures at least
annually to ensure they reflect changes in laws, regulations, and the
organization. They should also be updated anytime there is an internal policy
or procedure update. In some cases, specific rules impose their own
requirements. A great example is OSHA's Bloodborne Pathogens Standard requires
covered employers to review and update their Exposure Control Plan at least
annually and whenever necessary to reflect certain changes in tasks,
procedures, or employee positions involving occupational exposure.[3]
The HIPAA Security Rule requires a periodic documentation
review and updates as needed in response to any environmental or operational
changes that affect the security of ePHI.[4]
Similar to the OIG, this requirement does not establish a required annual
revision deadline for every HIPAA policy. Your maintenance process should
address both scheduled reviews, change driven updates, new technology, revised
workflows, organizational restructuring, incidents, and audit findings.
Ask prospective vendors or consultants who is responsible
for monitoring changes, how applicability is evaluated, and whether the service
includes actual policy revisions or only notifications. Make certain these
responsibilities are clearly spelled out in your contract with the vendor or
consultant.
What are the benefits of custom versus template-based policy solutions?
Templates can provide a useful starting structure, but it is
just that, a starting structure. Custom policy development goes further
by connecting the requirements to your organization's actual
responsibilities and processes.
For example, a generic security incident policy may instruct
employees to report concerns to the "security officer." A usable policy
identifies the responsible role, reporting channels, escalation process, and
supporting procedures. It should also match the technology and response
resources your organization uses. Customization matters because the HIPAA
Security Rule allows regulated entities to consider their size, complexity,
capabilities, infrastructure, costs, and risks when selecting "reasonable and
appropriate security measures."[5]
A policy should reflect those decisions rather than simply describe safeguards which
exist only on paper.
Templates are not inherently inadequate and likewise custom
documents are not automatically compliant. The meaningful distinction is
whether the final policy accurately addresses applicable requirements
and can be successfully implemented and acted upon when the time comes. When working
with a vendor or consultant, ask what "custom" includes. Replacing an
organization's name is vastly different from speaking with stakeholders,
evaluating workflows, identifying gaps, and revising procedures. Legal review,
implementation support, and future updates should be expressly included in the
agreement if you expect those services.
What is the process for outsourcing healthcare compliance policy development?
Step 1 - Discovery and Policy Assessment
Start by sharing your organizational structure, services,
locations, existing policies, and known concerns. There is no reason to waste a
lot of time for no reason so start with what you already have. Identify
internal stakeholders who understand privacy, security, billing, workforce
safety, and clinical operations.
Next, assess where your policies are and make sure to
distinguish missing documents from outdated, conflicting, or impractical
instructions.
Step 2 - Scope and Proposal
The proposal should identify the policies covered,
deliverable formats, review responsibilities, revision process, and anticipated
schedule through to completion. It should also explain what is not included, particularly state-specific analysis, legal advice,
training, and ongoing maintenance. If you are not sure if something is included,
ask straight-forward questions and make sure it is in writing and in your
contract with the vendor or consultant.
Step 3 - Drafting and Stakeholder Review
In this phase, the vender or consultant develops or revises policies
using your operational information. Internal stakeholders then check whether
the instructions are accurate, responsibilities are assigned correctly, and the
procedures are feasible. There should be a great deal of coordination between
the vendor or consultant and your organization during this phase.
If legal interpretation is necessary, establish who will
obtain legal counsel review and whether this work is included as part of the
contracted services. No one wants to get surprise legal fees at the end of a
project, especially if you have a strict budget to begin with.
Step 4 - Approval and implementation
Your organization should review and approve the final policy
documents through your established governance process. Implementation should
address staff access, communication, training, and replacement of superseded
versions.
Step 5 - Maintenance
Once you have invested in the policies, assign a policy
owner to ensure they remain up to date. Pick a review timeframe you can adhere
to, but no less frequently than annually if possible. Create a change management
process to track and address any change in policies. Do not count on someone's
memory to keep track of these changes. Document them! Finally, clarify if the vendor
or consultant's role ends at delivery or continues through future reviews and
updates.
What deliverables should I expect?
Always clearly define deliverables before signing the
agreement! There is nothing worse than expecting something to be covered and then
finding out it is not. Consider requesting editable policy documents, a policy
inventory, approval and effective date fields, version history, and
identification of the internal owner.
Supporting materials can include procedures, forms,
implementation guidance, or a summary of significant changes. These are useful
purchasing specifications, but they should not be assumed to accompany every
policy engagement.
Documentation management also deserves attention. Under the
HIPAA Security Rule, required documentation generally must be retained for six
years from creation or the date it was last in effect, whichever is later. Your
system should preserve required historical versions rather than simply
overwrite them.[6]
Ask how you will access and export documents if the
engagement ends. Ownership, licensing, and post-termination access should be spelled
out clearly in the contract.
How do I evaluate a healthcare policy consulting partner?
Look for a vendor or consultant that asks detailed
questions before promising a complete solution. A meaningful evaluation should
address experience with your organization type, relevant jurisdictions,
regulatory research methods, customization practices, and quality review.
Request a sample deliverable or walkthrough demonstrating how requirements
become practical instructions. Ask the vendor or consultant to explain how they
distinguish binding requirements from voluntary guidance. The OIG's guidance,
HIPAA regulations, and OSHA standards do not have identical legal status or
apply to every organization in the same way.
Also evaluate the working relationship. Who is your point of
contact? Who resolves conflicting stakeholder comments? What happens when a
policy needs urgent revision? If service-level commitments matter, ensure
response times and remedies appear in the agreement. Avoid treating promises of
"guaranteed compliance" as a substitute for a defined scope. (A side note:
if a vendor or consultant promises "guaranteed compliance" or a HIPAA Seal of
Approval, those are marketing gimmicks and a sign to look elsewhere. No
organization or consultant can guarantee compliance or issue a HIPAA seal of
approval.)
Policies support compliance but implementation,
oversight, and corrective action remain essential parts of an effective compliance
program.
Additional Frequently Asked Questions
Does outsourcing transfer compliance responsibility to
the provider?
No. Treat outsourcing as specialized support, not a transfer
of organizational accountability. Your organization still needs to approve
policies, implement applicable safeguards, and evaluate effectiveness. The
HIPAA Security Rule places those obligations on the covered entity.
Does every policy need to be rewritten annually?
No. Review and revision are different activities. An annual
review can confirm a policy remains accurate. The OIG recommends at least
annual policy reviews, while specific regulations may impose additional
requirements for particular documents.
Can we start with our existing policies?
Yes! Ask the vendor or consultant to assess existing
documents before recommending replacement. The scope can
distinguish policies to retain, revise, consolidate, or develop from scratch.
Will policy development include legal advice?
It depends on the vendor or consultant. Do not be afraid to
ask whether attorneys participate, which issues receive legal review, and
whether counsel's fees are included in their fee. A policy development
agreement should also clearly describe the service being purchased.
What should we prepare before requesting a quote?
Prepare your policy inventory, locations, services, known
compliance concerns, internal reviewers, and target timeline. Identify whether
you need a one-time project or continuing maintenance.
Take the Next Step
Request a consultation with Healthcare Compliance Pros to
discuss your existing documents, prioritize gaps, and operational needs. Ask
for a clearly scoped proposal covering customization, review, implementation
support, and ongoing updates.
The goal is not simply a larger policy library. It is documentation your organization can understand, approve, use, and maintain.