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What is the Best EMR for Small Practices in 2025?

Posted by Steve Alder

Whether you are starting a new practice or looking to grow your existing business, choosing the right electronic medical record system (EMR) is key to improving revenues and profits. An EMR is more than a system for managing large data records. An EMR is an invaluable tool at the heart of your practice that facilitates many aspects of your practice’s operations, such as scheduling, payments, insurance billing, record requests, patient engagement, telehealth, patient follow-ups, and HIPAA compliance.

In addition to ensuring accurate patient records, an EMR is an invaluable tool for aiding decision-making, improving efficiency by streamlining documentation, and eliminating manual administrative tasks that inevitably impact revenue-generating activities and patient care. An EMR can significantly improve the patient experience by streamlining scheduling, providing patients with easy access to their health data to improve engagement, and facilitating communication, helping to improve satisfaction and attract new patients.

With an EMR that is the right fit for your practice, you can reduce the administration burden on clinicians and administrative staff and improve efficiency, allowing you to spend more time providing high-quality, personalized, value-based care.

An EMR Streamlines Operations and Improves Efficiency

An EMR improves efficiency, streamlines data management and billing processes, while helping ensure compliance with HIPAA and state laws, but it is vital to get the right EMR solution for your practice that meets your current needs and has the scalability to support your practice as it grows.

There is a myriad of EMRs to choose from, and while Epic and Oracle Cerner are the most commonly used enterprise EMRs, they require a significant investment and are not well-suited for solo providers and small independent practices, as they prioritize operational scale and standardization.

EMRs for small practices are more affordable, easier to use, and offer far greater flexibility, often providing scope for customization to support specialty-specific workflows and value-based individualized care. The best EMR for small practices will allow you to streamline practice operations while meeting your regulatory obligations under HIPAA, EPCS, and other federal and state regulations, allowing you to concentrate on providing the highest quality patient care.

With the right EMR, you will be able to significantly reduce time-consuming administrative tasks, improve clinical accuracy, and deliver a better patient experience, helping you to reduce the churn rate and win more business.

Choosing an EMR for Small Practices

Cost is naturally a key consideration for small practices. Setting up a new practice costs hundreds of thousands of dollars, after which there are likely to be considerable budgetary constraints. You naturally need to get good value for money and a significant return on your investment, but it is important to look past the cost of licenses and initial setup costs, which include data migration if you are changing EMRs. There are often ongoing monthly expenses, add-on costs for integrations and improving core EMR functionality, limited logins, and locked-in insurance billing partners and other vendors.

If you are starting out and have a handful of clients, what works initially may not be sustainable over time. Transitioning to a new EMR when you outgrow your current platform can be time-consuming and costly, with data migration headaches and a long learning curve, which will inevitably negatively impact operations until the staff gets up to speed.

It is therefore important to choose an EMR for small practices that has comprehensive features, supports extensive integrations, with workflow automation allowing for efficient practice management. The solution should incorporate business features, including billing and analytics, while supporting telehealth, electronic prescriptions, and compliance, with scalability to support the changing needs of your practice. The support options should not be overlooked, as if you experience any technical problems or require customizations, assistance should be provided quickly to allow you to rapidly resolve your issues.

A free EMR may seem like the best choice if you have a limited budget and competing priorities. While initially you could save hundreds or thousands of dollars, you may end up paying more in the long term due to limited functionality, a lack of live customer support.  You will generally only get basic features, and the core components generally do not extend to billing, comprehensive reporting, and analytics. Free EMRs are generally only free up to a point and often require an upgrade to a full or premium package to get more than the basic EMR functions. There are also security and compliance risks associated with free EMRs, many of which are open source.

If you have a clear vision for your practice and your area of specialization, a free EMR may be a good choice, but the lack of flexibility can be limiting, and the money saved on capital outlay could be lost – and more. There are, however, excellent low-cost EMRs for small practices with extensive functionality and comprehensive integrations to meet your current and future needs, that are easy to use and support individualized care.

Security and Compliance

Two areas that should not be overlooked are security and compliance. Security needs to be built into the core of the design, as the EMR contains the crown jewels of your business, and hackers are actively targeting small practices. Free EMRs are typically open source, which means the code is available to anyone to inspect, but that doesn’t mean that it has been thoroughly inspected, nor that there is an active community looking at the code to identify security weaknesses. Data leakage and security vulnerabilities can prove extremely costly.

While small practices were once able to fly under the radar, regulators are taking a keen interest in HIPAA compliance at small medical practices. The HHS’ Office for Civil Rights (OCR) has an enforcement initiative on patient access, and in recent years, many financial penalties have been imposed on small providers for noncompliance. The HHS is also cracking down on information blocking, so it is vital that your EMR provides an easy-to-use patient portal and supports seamless health data exchange.

The Best EMRs for Small Practices

The best EMRs for small practices strike a good balance between cost and functionality, providing the functions to meet your operational needs, scalability to grow with your practice, and support to resolve technical or usability issues quickly, without hidden costs.

The best EMRs for small practices streamline operations, allowing you to improve patient engagement, reduce the burden of compliance, and have flexibility and support customizations to meet your unique needs. To save you time in your search, the HIPAA Journal has assessed EMRs for small practices to help you find the best EMR to meet your practice’s needs.

OptiMantra is the Best EMR for Small Practices

In our opinion, OptiMantra is the best EMR for sole providers and small independent primary care, functional medicine, mental health, and aesthetics-focused practices due to a comprehensive range of features and integrations, excellent customer support, scalability, and scope for customization. The platform provides excellent value for money with one of the lowest monthly costs, and many features included with the license that other platforms provide only as paid add-on features.

OptiMantra is an all-in-one solution with a comprehensive suite of functions, including charting, scheduling, e-prescribing, billing, video chat for telehealth, and an integrated lab network for bloodwork and tests. The platform includes a HIPAA-compliant patient portal with email and text reminders to improve engagement and reduce no-shows, and an extensive library of forms, including MSQ, symptom surveys, mental health questionnaires, and email, text, and fax templates.

OptiMantra offers a full suite of clinical, billing, point of sale, digital, and cloud integrations, ensuring seamless integration with the most commonly used third-party service providers. The platform streamlines small practice operations, allows charting on the go through tablet and mobile-friendly interfaces, helping practices improve efficiency and concentrate on patient care. OptiMantra also reports that clinics see an average 37% increase in revenue in the first year of using the platform, and if you ever decide to change platforms, there is no tie-in other than a month’s notice.

OptiMantra is rated highly by users, with a 5/5 score on G2 and a 4.8/5 score on Capterra, and is universally praised for customer support, with responses typically received within an hour, earning OptiMantra a 2025 Best Customer Support software badge from Gartner-owned Software Advice.  OptiMantra is also highly responsive to suggestions and rapidly implements tweaks to improve usability in response to customer requests.

While we feel OptiMantra is the best EMR for small practices for features, flexibility, cost-effectiveness, and customer service, other platforms are worthy of consideration.

AdvancedMD is a Comprehensive All-in-one Solution with Strong Revenue Management Features

AdvancedMD is an all-in-one cloud-based EMR system aimed at small practices, although those at the larger end of the category. The platform includes a suite of features for independent medical practices, including mental health, physical therapy, and medical healthcare organizations, and has integrated scheduling, charting, billing, claims, e-prescribing, and telehealth capabilities, with a good patient portal and patient messaging feature for improving engagement.

The platform offers excellent stability and accessibility, and robust security for HIPAA Security Rule compliance, including multi-factor authentication. AdvancedMD has an excellent scheduling system, a good patient portal, and impressive revenue management features, making it an ideal choice for practices with their one in-house billing teams.

While the platform has extensive features to support single physicians and small practices, with excellent scalability to support practices as they grow, there are more cost-effective choices due to high set-up fees. Due to the high initial cost, users typically do not tend to see a return on their investment for 14 months, and the system generally takes around 2 months to fully implement. Once set up, the platform is easy to use and navigate, with well-functioning modules that are intuitive and a great choice for compliance, with a comprehensive audit trail with all actions time and date stamped.

AdvancedMD has a 3.6/5 rating on Capterra and a 3.6/5 rating on G2 and is praised for its customizable features and the ability to tailor workflows to specific practice needs, and while the platform is reliable with excellent uptime, it is prone to lag times during busy periods, and customer service and issue resolution are often subject to delays. Overall, the platform is a good choice for larger practices and medical groups.

Practice Fusion is a Good Low-Cost Choice Providing Basic EMR Functionality

Practice Fusion is a solid choice for practices with restrictive budgets, especially for new sole provider practices and small practices with 3 or fewer signing staff. Practice Fusion is an entry-level cloud-based EMR system that initially provided free-to-use basic functionality, although it has now moved to a subscription-only service with a 14-day free trial.

Set up is straightforward, and the platform is intuitive and easy to use, without a steep learning curve. The platform has basic reporting and scheduling capabilities, web-based charting and e-prescribing, and lab, imaging, and billing services, and a good patient portal.

Practice Fusion provides online and telephone support, although it has no dedicated customer service representatives for users, and response times can be slow, sometimes taking days rather than hours to resolve issues.

The platform has a 3.8/5 rating on G2 and a 3.7/5 rating on Capterra, with users praising the platform for ease of use, its lab and imaging integrations, and web-based charting and e-prescribing. There is a lack of integrations and interoperability, although improvements are continuously being made to integrate with other portals and improve patient record importing, and extend integrations with vendors. Users report some system stability issues, with occasional downtime due to crashes.

For single providers and practices with 3 or fewer signing staff, Practice Fusion is a good choice due to ease-of-use, solid core functions, a good patient portal, and lab, imaging, and billing capabilities. A free trial is strongly recommended, as there is a minimum tie-in of 12 months for subscriptions with no early cancellation.

The post What is the Best EMR for Small Practices in 2025? appeared first on The HIPAA Journal.

Editorial: HIPAA Compliance Challenges for Small Medical Practices

Posted by Steve Alder

Healthcare providers, health plans, healthcare clearinghouses, and their business associates are all required to comply with the HIPAA Rules; however, there are unique challenges for small medical practices. Large healthcare organizations have greater resources to devote to compliance, and can attract and pay for dedicated compliance professionals, in-house IT and cybersecurity staff, cutting-edge cybersecurity solutions, and staff training programs.

Small medical practices have limited resources and are forced to make difficult decisions about where to allocate funds due to budget constraints. Investments in the business that boost revenue and profits often take priority over investments to ensure HIPAA compliance and improve cybersecurity. Small practices often cannot afford to have a dedicated HIPAA Privacy and Security Officer, and compliance duties fall on administrative staff, nurses, and physicians, who have many other responsibilities. There may also not be an in-house IT department to oversee security.

Despite financial constraints, HIPAA compliance and cybersecurity are not optional. The HHS’ Office for Civil Rights (OCR) has made it clear that the size of a practice is irrelevant when it comes to HIPAA compliance. While OCR has previously focused its enforcement efforts on larger practices, in recent years, OCR has taken a keen interest in smaller practices and has imposed several penalties for noncompliance. OCR has made it clear with these penalties that small medical practices can no longer fly under the radar.

The probability of noncompliance being discovered is increasing. While hackers and ransomware groups have historically focused their efforts on attacking larger healthcare organizations with deeper pockets, smaller healthcare practices are increasingly being targeted for the simple reason that they are easier to attack, as they have fewer resources to devote to cybersecurity, and healthcare organizations of all sizes are at risk of insider threats, more so than any other sector.

OCR’s figures show a 239% increase in hacking-related data breaches between 2018 and 2023, and a 278% increase in ransomware attacks. OCR investigates all data breaches affecting 500 or more individuals to determine if they were due to noncompliance, as well as many smaller breaches. Complaints about potential HIPAA violations are also being reported to OCR in record numbers, and OCR has rekindled its HIPAA audit program. Noncompliance has never been more likely to be discovered.

HIPAA Compliance Challenges for Small Medical Practices to Overcome

With fewer resources available to devote to HIPAA compliance, achieving and maintaining HIPAA compliance can be a real challenge for small and medium-sized healthcare providers. While small practices are not expected to invest as heavily in cybersecurity as large healthcare providers, they must ensure that they have appropriate measures, relative to their size, to protect against common cybersecurity threats.

Small medical practices must ensure they have written policies and procedures to demonstrate their good faith effort to comply with the HIPAA Rules. HIPAA compliance is not inherently complicated. The HIPAA Rules are publicly available, and OCR has created many resources to help small practices achieve and maintain compliance, yet there are several areas where smaller practices have compliance programs that fall short of requirements.

Document All HIPAA Compliance Efforts

A lack of documentation to prove HIPAA compliance is all too common. As far as OCR is concerned, if it hasn’t been documented, it didn’t happen. If a complaint or data breach is investigated, the first thing OCR will request is documentation to demonstrate HIPAA compliance in the area under investigation. That may be policies and procedures for responding to patients who exercise their rights under HIPAA, HIPAA and security awareness training records, incident response plans, and patient notifications, or evidence that a risk analysis has been conducted and risks have been reduced to a reasonable and appropriate level. Many financial penalties have resulted from the failure to document the practice’s good-faith effort to comply with the HIPAA Rules. Maintaining accurate documentation is a fundamental requirement of HIPAA.

Conduct Regular Risk Analyses

The most commonly identified HIPAA violation is the failure to conduct an accurate and comprehensive risk analysis. Under OCR’s current enforcement initiative, proof that a risk analysis has been conducted will need to be provided in the event of a data breach investigation. Risk analyses are ongoing requirements that should be conducted annually, and following any material change to policies and procedures, or when new technology is introduced.

The “comprehensive” requirement means that there is a prerequisite to the risk analysis. An accurate and up-to-date inventory of all devices and locations where PHI is stored, maintained, transmitted, or accessed is required, on which the risk analysis can be based. Take advantage of the HHS Security Risk Assessment tool, which has been developed specifically to help small and medium-sized healthcare providers by walking them through the risk analysis process. You must also ensure that everything is documented so you can demonstrate that an accurate and comprehensive risk analysis has been conducted. Naturally, any identified risks and vulnerabilities must be mitigated in a timely manner.

Reduce the Risk of Human Error with Regular Training

Staff training often gets neglected. It can be difficult with a small workforce to take workers away from their work duties and provide regular training on HIPAA policies and procedures, as well as security awareness training. Training should be provided at hire, and refresher training provided annually. Take advantage of training vendors and third-party courses if you lack the internal resources to develop your own training courses.

Training should teach employees about their responsibilities with respect to the privacy and security of PHI, patient rights under HIPAA, social media use, and the correct handling of PHI in all forms. Ensure you provide regular security awareness training covering common threats such as phishing, social engineering, malware, and educate the workforce on security best practices. To develop a culture of compliance, staff members must be given proper education, and through regular training, you will be able to prevent many accidental HIPAA violations. Bear in mind that patients have become a lot more knowledgeable about HIPAA and their rights, and complaints about potential HIPAA violations are being reported in record numbers.

Maintain Business Associate Agreements with All Vendors

With limited resources, small medical practices will naturally need to outsource some functions to third-party service providers such as IT companies, managed services providers, cloud providers, software providers, revenue cycle management companies, and more. A small practice may rely on two dozen or more vendors, and each one that requires contact with PHI must sign a business associate agreement (BAA) before being provided with access to PHI.

The BBA should make clear what the vendor’s responsibilities are under HIPAA, the safeguards that are required to protect PHI, and the requirement to obtain a BAA before using any subcontractor that requires access to PHI. The BAA should stipulate responsibilities and timeframes for reporting security incidents. There are many free templates available on which small practices can base their business associate agreements.

Business associates should be vetted to ensure their security is up to scratch, which can be time-consuming for small practices. Time can be saved by choosing vendors who can provide evidence of their security practices and who attest that their products or services are HIPAA compliant.

Implement Strong Access Controls

Small medical practices are likely to be targeted with phishing, social engineering, and brute force attempts to guess credentials. To counter these threats, practices need to have strong access controls. Each member of the workforce must have unique credentials, password complexity requirements should be set and enforced in line with current NIST recommendations, and multi-factor authentication should be implemented to add an additional layer of security, especially for any Internet accessible account or system.

Maintain and Review Security Event Logs and PHI Access

Even with the best security, cybercriminals may exploit human weaknesses or find a way to access your network. Data encryption at rest and in transit is strongly recommended, and a requirement of HIPAA unless an alternative safeguard is implemented that provides an equivalent level of protection. Regular backups must be performed of all critical data, backups checked to make sure data recovery is possible, and backups should be stored securely off-site. Small practices have been forced to permanently close due to the inability to recover data following a ransomware attack.

HIPAA requires detailed audit logs to be created, maintained, and reviewed to identify access, use, copying, and modification of ePHI. The logs should be continuously monitored, which, for small practices with limited resources, naturally requires automation. Consider partnering with a managed service provider (MSP) or managed security service provider (MSSP) and leveraging their expertise and monitoring capabilities. Without an automated system for monitoring ePHI access logs, including AI-aided detection of anomalous activity, privacy violations can continue for years.

Develop and Test an Incident Response and Business Continuity Plan

Small practices must prepare for the worst and assume that there will be a breach or HIPAA violation. An incident response plan must be developed that includes procedures to follow in the event of a cyberattack or event that damages information systems containing ePHI, or involves potential unauthorized access or disclosures.

The plan must include each individual’s responsibilities, the procedures that must be followed, processes for mitigating damage, and vendors that can assist, such as digital forensics experts and cybersecurity professionals. The plan must be tested to ensure that it is effective and that everyone is aware of their responsibilities. The incident response plan should also include policies and procedures for issuing notifications to the HHS, affected individuals, and the media. Small practices have been fined for breach response failures.

Prioritize Cybersecurity Spending to Get the Biggest Bang for Each Buck

Budgetary constraints at small medical practices mean difficult decisions must be made about cybersecurity, so each security product purchased must have a significant impact on reducing risk. Leverage affordable tools to ensure that email is secured, encrypt data at rest and in transit as far as is possible, and take advantage of HIPAA-compliant service providers rather than trying to build your own security from scratch. Enlist the services of an MSP or MSSP to assist with Security Rule compliance and benefit from their expertise; just make sure the vendor’s responsibilities are clearly stated in the BAA and service level agreement.

Small practices may have to make compromises as their resources may not stretch to cutting-edge security in every area. To get the biggest bang for each buck, the HHS Cybersecurity Performance Goals are a good place to start. They include proven cybersecurity measures that will have the biggest impact on improving your security posture.

Keep Up to Date with Regulatory Changes

Major changes to the HIPAA Rules are relatively infrequent, but there are pending Privacy Rule and Security Rule updates, and minor changes are more frequent. It is the responsibility of small medical practices to keep up to date with regulatory changes, as a lack of knowledge is not a valid excuse for noncompliance. Keeping abreast of any proposed HIPAA changes will give small practice owners plenty of time to make the necessary updates to their policies, procedures, and data privacy and security practices. Regularly check the HHS.gov website for proposed updates and new guidance, and sign up for The HIPAA Journal newsletter to get updates sent directly to your inbox.

HIPAA Compliance is a Continuous Process

HIPAA compliance is a continuous process, not a one-time effort at checking all the compliance boxes, and that naturally requires an investment in time and resources. To ensure compliance is maintained, consider conducting annual HIPAA audits and documentation checks, and regularly review privacy and security policies to ensure that they continue to be effective. Investing time and resources into developing your compliance program will be money well spent.

Steve Alder, Editor-in-Chief, HIPAA Journal

The post Editorial: HIPAA Compliance Challenges for Small Medical Practices appeared first on The HIPAA Journal.

Why HIPAA Compliance Software Is Perfect For Small Medical Practices

Posted by Ian

For most small medical practices HIPAA compliance software is a very helpful and inexpensive tool that makes navigating the complexities of HIPAA simple, while also fostering peace of mind through a comprehensive risk management processes.

Best HIPAA Compliance Software For HIPAA OfficersAt smaller organizations with under 100 employees, responsibility for HIPAA compliance normally falls to an administrator or practice manager who usually won’t have deep knowledge of compliance matters. For these multitasking individuals, HIPAA compliance software reduces the administrative burden and lessens the likelihood of an expensive HIPAA breach.

What Are The Benefits Of HIPAA Compliance Software?

The benefits of using HIPAA compliance software for an administrator or practice manager are as follows:

  • Reduced Administrative Burden: HIPAA compliance software automates many administrative tasks related to compliance management, such as tracking training requirements, managing documentation, and scheduling audits. This frees up time and reduces the administrative burden.
  • Effective Risk Management: HIPAA compliance solutions provide tools for conducting risk assessments, identifying vulnerabilities, and implementing risk mitigation strategies.
  • Confidence In Role: The best HIPAA compliance software offers built-in guidance, templates, and best practices to support compliance efforts. This helps the compliance officer feel more confident in their ability to fulfil their responsibilities, even without specialized training or expertise in compliance matters.
  • Reduced Stress: By using HIPAA compliance tracking software, individuals can feel reassured that they are taking all necessary steps to protect patient information and maintain compliance with HIPAA. This peace of mind reduces the stress and uncertainty associated with compliance management.

What To Consider When Purchasing HIPAA Compliance Software?

By following our buyer’s guide framework, you can make a thorough assessment of the best HIPAA compliance software options and select the most suitable solution to support your organization’s requirements. There are three aspects to consider when purchasing HIPAA compliance software which are discussed in detail below:

1. Essential Functionality

2. Software Specifications

3. Business Considerations

1. What Essential Functionality Is Required For HIPAA Compliance Software?

The best HIPAA compliance software should be a flexible system that follows a recognized framework like the HHS’s Seven Fundamental Elements Of An Effective Compliance Program. It should offer both a prebuilt approach and customizable options.

The solution needs to ultimately provide proof of compliance for patients, clients, and auditors, and ideally offer a certification process for this.

For compliance officers with little experience, the initial setup of the software is key. The best HIPAA compliance solutions offer some form of live compliance coaching to guide you through each step of setting up your HIPAA compliance program. 

The following essential functionality will allow you to confidently address your organization’s compliance requirements:

1. Risk Assessment

  • Risk assessment tools
  • Risk scoring
  • Gap identification
  • Remediation planning
  • Evidence tracking (for inspections)
  • Guidance wizards to help set-up and identify action plan

2. Incident Response

  • Anonymous incident reporting for employees
  • Breach incident reporting
  • Breach management tools

3. Policies & Procedures

  • Templated and customizable policies and procedures
  • Policy and procedure management
  • Central storage of policies and procedures
  • Employee attestation management
  • Employee portal for easy access to review policies

4. Employee Training

  • Train, track, and manage HIPAA compliance training for employees
  • Up-to-date HIPAA compliance training modules
  • Personalized, individual employee training certificates
  • Training beyond HIPAA covering other HR needs such as OSHA and Fraud Waste & Abuse

5. Vendor/ Business Associate Management

  • Identify and track business associates
  • Customizable business associate agreement templates
  • Store and track business associate agreements
  • Vendor due diligence and risk scoring
  • Contract management and vendor exclusion screening

6. Multi-Site Management

  • Manage the compliance levels at each site in an organization separately

7. Reporting

  • Customizable reporting templates including reports to demonstrate compliance to stakeholders or regulators
  • Centralized documentation storage
  • Audit logging and reports

8. Employee Screening (not essential)

  • Ability to check the HHS OIG Exclusions list
  • Sanction screening 
  • Employee conformance scoring
  • HRIS integrations

Healthcare Compliance CategorieWhat other features should you consider for your HIPAA compliance solution?

  • Consider if you also need OSHA (Dental or Medical) and SOC 2 compliance, and if so, ensure your chosen software can provide this as an all-in-one healthcare compliance solution.
  • Does the software allow you to customize your own compliance standards?

2. What Are The Software Specifications To Consider For HIPAA Compliance Solutions?

Software specifications are aspects of a solution, such as usability or scalability, that are not about specific functionality but describe the broader qualities of the software. Specifications will help inform your decision when comparing HIPAA compliance software solutions.

1. Ease Of Use

  • Assess the software’s overall user experience, including the user interface and navigation around the solution.
  • Does it have an intuitive interface that includes guided workflows for conducting compliance activities? This is vital to make it easier for individuals without deep compliance expertise to navigate the compliance process.
  • How user-friendly are the training modules that employees will be required to take as part of the organization’s compliance?

Best HIPAA Compliance Software Dashboard

2. Scalability & Flexibility

  • Can the software accommodate your organization’s current scale, for example, to manage multiple locations?
  • Can it scale up and adapt to your organization’s evolving future needs?

3. Integration Capabilities

  • How will the software integrate with your existing IT infrastructure and the other third-party applications used within your organization?
  • Cloud-based solutions are the easiest to implement, and have the advantage that ongoing infrastructure maintenance is the responsibility of the software vendor.

4. Future Proofing

  • How will the software vendor address regulatory changes and updates to ensure ongoing compliance in a timely manner?

3. What Are The Business Considerations When Choosing Software?

You may find that when evaluating functionality and specifications, a favored vendor will emerge and you feel ready to award them the business right away. It is highly recommended that you don’t allow yourself to be pressured into a fast decision before fully examining the commercial and business considerations.

1. Vendor Reputation

  • Is the software endorsed by any medical associations?
  • Do they have current case studies and testimonials from other healthcare organizations that have successfully implemented the software?
  • It is always a good idea to request references i.e. to directly speak with existing customers about their experiences with both the software and the vendor.

2. Vendor Training & Support

  • Does the vendor offer live support to guide you through the setup of their HIPAA compliance software solution?
  • Is there a separate cost for this, or is it included in the price?
  • After setup what ongoing support is offered and it is this included in the vendor’s annual charges?

3. Costs

  • Look for a transparent breakdown of pricing structures, including initial setup costs, licensing fees, and any additional charges for support or updates.
  • Is there a one-time purchase cost or is it a subscription-based model? Subscriptions have become the most common way to purchase cloud-based software.
  • If cost is an issue and it appears that the solutions on your shortlist are similar, ensure you create a price comparison table taking all factors into account, such as extra costs for training or support. For example, whether HIPAA training is included or not.
  • Does the vendor offer discounts? For example, they may offer a group discount for an association you may already be a member of. It’s always worth asking as often this can be 15% or more off the list price annually.

4. Free Trial Or Money Back Guarantee

  • A full demonstration may be enough to help you make your decision, but sometimes a short trial period can be helpful if you have any doubts. It also allows you to ask your colleagues to take a look before a final decision is made.
  • Not all software is suitable for a free trial because of the effort required for the setup by both the vendor and the customer. In this scenario, you could ask for a guarantee that if you are not satisfied you have the option to back out of the agreement within a certain timeframe, like 30 days.

5. Software License Period

  • What is the commitment period you are signing up for? Is it month-by-month or year-by-year? Is there a minimum period such as three or five years? Read the small print on any agreement.
  • The advantage of shorter periods is that the onus is on the software vendor to ensure you are kept happy because they won’t want you to cancel. Alternatively, if you are willing to sign up for a longer period, or pay for a year in advance, then the annual costs may be reduced.

Free Buyer’s Guide

We have compiled a free buyer’s guide to choosing HIPAA compliance software. This includes a checklist for the three aspects discussed in this article where you can rate up to three different solutions and compare your results.

This guide to choosing the best HIPAA compliance software can be downloaded by filling in the form on this page.

 

The post Why HIPAA Compliance Software Is Perfect For Small Medical Practices appeared first on The HIPAA Journal.

Seven Elements Of A Compliance Program

Posted by HIPAA Journal

The Seven Elements HIPAA Compliance Software SolutionThe seven elements of a compliance program are integrated processes organizations can adopt to help develop a culture of compliance in the workplace; and, when applied effectively, the seven elements can also be used to streamline operational processes, optimize organizational performance, and reduce overall costs.

Because HIPAA compliance can be confusing, we have compiled this guide to the seven elements to make them relevant for HIPAA. Some compliance software solutions guide compliance officers through the seven elements as part of their set-up process.

Summary Of The Seven Elements

While the seven elements of a compliance program apply to all industries, they originated in the healthcare industry in the 1990s. This was in response to the growing level of healthcare fraud and abuse and an alleged “compliance disconnect” at the executive level in many hospitals and health systems.

These are the seven elements, which we outline in more detail below:

#1: Implement written policies, procedures, and standards of conduct.
#2: Designate a compliance officer and a compliance committee.
#3: Conduct effective training and education.
#4: Develop effective lines of communication.
#5: Conduct internal monitoring and auditing.
#6: Enforce standards through well-publicized disciplinary guidelines.
#7: Respond promptly to detected offenses and undertake corrective action.

The Seven Elements For Effective HIPAA Compliance

Despite being more than twenty-five years old – and not necessarily having been adopted to tackle the same issues – many organizations still use the seven elements in their original format.

The Background to the Seven Elements

In 1991, the Department of Health and Human Services (HHS) launched the Workgroup for Electronic Data Interchange (WEDI). WEDI had the objective of reducing administrative costs in the healthcare system by promoting electronic claims submission.

It achieved its objective by requiring insurance carriers to reimburse healthcare providers more quickly for electronic claims than for paper claims, thus encouraging providers to submit more claims electronically.

As a result, the percentage of claims submitted electronically over the next five years more than doubled – making it harder for adjudicators to identify fraud and abuse attributable to unbundling, duplication, and global service violations.

According to a Congressional Report published by the General Accounting Office in 1995, it was estimated that as much as 10 percent of national healthcare spending was attributable to waste, fraud, and abuse (around $98 billion at the time).

The following year, the long-running Caremark Derivative Litigation case concluded – a case in which it was claimed the company’s board of directors had failed in their fiduciary duty of care to ensure the company’s compliance program was enforced.

Although cleared of “lacking good faith in the exercise of monitoring duties or conscientiously permitting a known violation to occur”, the company settled multiple felony charges against it by paying $250 million in civil and criminal fines.

The relevance of this case is that Caremark’s primary operations were providing patient care and managed care services; and, although the company had implemented compliance policies to prevent breaches of Anti-Referral Payments Laws, a series of violations resulted in shareholders claiming the board of directors had failed to adequately enforce the policies and, as a result, exposed the company to regulatory fines.

This accusation was not lost on the HHS’ Office of Inspector General (OIG).

OIG Publishes First Model Compliance Plan

The year after the conclusion of the Caremark Derivative Litigation case, OIG published its first model compliance plan (62 FR 9435-9441). Although aimed at clinical laboratories, the model compliance plan consisted of seven “compliance plan elements” that subsequently evolved into “the seven fundamental elements of an effective compliance program” in later compliance plans for hospitals, home health agencies, hospices, and nursing facilities.

The primary objective of the plan is fairly transparent. In the preamble to each of the plans, OIG states “many providers and provider organizations have expressed an interest in better protecting their operations from fraud and abuse through the adoption of voluntary compliance programs.” The word “fraud” is repeated a further twenty-eight times in the compliance plan for hospitals (63 FR 8987) and the compliance plan for nursing facilities (65 FR 14289).

It is also noticeable that, from the second plan onward, each plan includes a footnote stating “recent case law suggests that the failure of a corporate Director to attempt in good faith to institute a compliance program in certain situations may be a breach of a Director’s fiduciary obligations” – referencing the Caremark Derivative Litigation case. Clearly, OIG wanted to send the message that, if a voluntary compliance plan was implemented, oversight of the plan was expected.

The biggest influence for the creation of the seven elements of a compliance program (fraud prevention) is sometimes overlooked. This is not necessarily a bad thing because – around the same time – the passage of HIPAA introduced fraud controls and transaction standards that made it harder for healthcare providers to defraud or abuse the system. However, the seven elements can be adapted for more positive purposes than preventing, detecting, and responding to fraud.

What are the Seven Elements of a Compliance Program?

The Seven Elements Of A Compliance ProgramSince the first appearance of the seven elements, some versions have been amended or extended to meet organizational or regulatory requirements.

For example, when the Affordable Care Act made a compliance program a requirement of Medicare participation for some healthcare providers (42 CFR §483.85), an element was added that prohibits organizations from delegating discretionary authority to individuals who “the organization knew, or should have known through the exercise of due diligence, had the propensity to engage in criminal, civil, and administrative violations of the Social Security Act.”

However, as mentioned in the introduction to this article, many organizations that have implemented a compliance plan voluntarily still use the seven elements of a compliance program in their original format.

Please use the form on this page to arrange to receive a free copy of the HIPAA Compliance Checklist to use with the seven elements of a compliance program.

#1 Implement written policies, procedures, and standards of conduct

The best HIPAA compliance softwareThe seven elements of a compliance program are often depicted as a linear “start-to-finish” program or as a wheel that starts revolving again when it is completed its first cycle. Neither depiction is entirely accurate, as the seven elements of a compliance program have to integrate with each other at all times to make the program work effectively and facilitate improvements to the program.

The first of the seven elements of a compliance program is a suitable example of why it is important to view a compliance program holistically because it calls for the development of standards (etc.) under the direction of a compliance officer. Yet organizations are not advised to designate a compliance office until element #2:

“Every compliance program should develop and distribute written compliance standards, procedures, and practices that guide the facility and the conduct of its employees throughout day-to-day operations. These policies and procedures should be developed under the direction and supervision of the compliance officer, the compliance committee, and operational managers.”

If you view the seven elements of a compliance program as a linear program, you could be confused when the second element instructs you to designate the compliance officer you need to complete the first element. You might also be confused if you view the compliance program as a wheel, because it means you will need to rotate the wheel counter clockwise from #2 to #1.

#2 Designate a compliance officer and compliance committee

The temptation with element #2 is to delegate the role of compliance officer and the membership of a compliance committee to members of the same HR, legal, or operations teams or department heads of these teams. This can be a mistake if (for example) the legal team does not understand the real-life challenges of compliance in the workplace.

While it is a good idea to head the compliance committee with a person of authority, it is beneficial to include personnel with public-facing roles (i.e., healthcare professionals) and a mixture of personnel from IT, security, and administration who can provide insights on which policies will work and which won’t without changes to working practices.

#3 Conduct effective training and education

Integrating training and education into a compliance program should not be difficult for most organizations in the healthcare industry, as the majority are required to comply with the HIPAA training requirements, while some are also required to provide annual compliance training as a condition of participation in the Medicare program.

Of significance, in the original seven elements of a compliance program, OIG notes that the continual retraining of personnel at all levels (emphasis added) is a significant element of an effective compliance training program. Along the same lines, OIG adds that adherence to the elements of the compliance program should be a factor in evaluating the performance of managers and supervisors.

#4 Develop effective lines of communication

The development of effective lines of communication is pivotal to the seven elements of a compliance program because effective lines of communication are necessary for members of the workforce to raise questions, report violations, and provide feedback on corrective action plans that may necessitate amendments to policies and procedures and further training.

Ideally the creation and maintenance of effective lines of communication between the compliance officer/committee and the workforce should include a hotline or anonymous reporting system to receive questions, reports, and feedback. Organizations should also adopt procedures to protect the anonymity of complainants and to protect whistle-blowers from retaliation.

#5 Conduct internal monitoring and auditing

This element of an effective compliance program provides an opportunity for executive officers to demonstrate oversight by requesting compliance reports and audits from the compliance officer. In healthcare environments, these reports and audits should be conducted regularly to comply with the HIPAA requirement for regular risk analyses and be available at all times for executive review.

If executive officers participate in this element, it also provides an opportunity to extend lines of communication “from the top to the bottom”. Although it is not always practical to have members of the workforce communicate directly with executive officers (and vice versa), the involvement of executive officers demonstrates a commitment to compliance throughout the entire organization.

#6 Enforce standards through well-publicized disciplinary guidelines

Most organizations distribute disciplinary guidelines at the point of training. Indeed, in the healthcare industry, the standards relating to training and sanctions are almost adjacent to the Administrative Requirements of the Privacy Rule – so it is rare that an explanation of the organization’s sanctions policy is not included in initial HIPAA training.

With regard to enforcing standards, it is important that sanctions are applied fairly. If one group of the workforce is sanctioned more often or more harshly than another group for no justifiable reason, executive officers need to find out why. While it may be the case that one manager is enforcing standards over-zealously, it may equally be the case that another manager is allowing the workforce to take shortcuts with compliance “to get the job done”.

#7 Respond promptly to detected offenses and undertake corrective action

When the seven elements of a compliance plan were originally published in the 1990s, this element focused almost entirely on detecting fraud, reporting it, and enforcing sanctions or implementing measures to prevent it from happening again. With fraud prevention being a less important objective of a compliance plan than it was twenty-five years ago, this element can be used to monitor the effectiveness of the compliance program and improve it where necessary.

For example, if an offense has occurred due to a loophole in a policy (element #1), a lack of training (#3), a communication failure (#4), or a monitoring issue (#5), the compliance officer (#2) can evaluate the existing policies, procedures, and standards, and adjust them as necessary (#7). If the offense has occurred due to the actions of a non-compliant member of the workforce, it may be necessary to increase the penalties in the sanctions policy (#6) to be more of a deterrent.

The Challenges and Benefits of Adopting a Compliance Plan

Software For Compliance OfficersAdopting the seven elements of a compliance plan can be challenging for an organization starting from scratch. It can be difficult to get leadership buy-in because compliance is not perceived as a revenue generator, it can be difficult to define compliance roles in a complex regulatory environment, and it can be difficult to pull everything together with limited resources.

In healthcare environments, these challenges are mitigated by the fact that many of the elements are – or should be – already in place. HIPAA-covered entities should have developed policies and procedures to comply with the Privacy Rule, have a training and sanctions program up and running, and have procedures for conducting internal audits and responding to data breaches.

All that needs to be done in many healthcare environments is for the compliance officer to bring together the seven elements of a compliance plan into one integrated plan. When managed effectively, the plan will help organizations develop a culture of compliance that can help to reduce costs (i.e., regulatory fines), enhance the organization’s operations (i.e., through improved communication), and advance the quality of healthcare.

This final benefit of adopting a compliance plan is one many organizations are only starting to realize as it has only recently been demonstrated that, when patients believe PHI will remain confidential, they tend to be more forthcoming about healthcare issues. This enables healthcare professionals to make better-informed diagnoses and prescribe more effective courses of treatment, which results in better patient outcomes, satisfaction scores, workplace morale, and staff retention.

Get Help Developing Your Compliance Plan

Multiple sources on the Internet offer help with developing a compliance plan. One of the best is the HHS’ Office of Inspector General compliance guidance web page which includes updated guidance on the seven elements of a compliance program in its General Compliance Program Guidance document.

However, if your organization is a multi-disciplined Covered Entity or Business Associate, and you need more granular help developing a compliance plan, it may be worthwhile reviewing our HIPAA compliance checklist.

Steve Alder, Editor-in-Chief, The HIPAA Journal

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How To Become HIPAA Compliant

Posted by HIPAA Journal

One of the simplest ways how to become HIPAA compliant is to adapt HHS’ “The Seven Fundamentals of an Effective Compliance Program” to address compliance challenges identified in a HIPAA risk assessment. Thereafter, it can be beneficial to take advantage of HIPAA compliance software in order to maintain a compliant workplace.

7 Steps for HIPAA Compliance

In 2011, HHS published “The Seven Fundamental Elements Of An Effective Compliance Program”. We have slightly amended it to be more relevant to HIPAA compliance in 2025. Here is a summary of the elements, which we outline in more detail in this guide.

  1. Develop policies and procedures so that day-to-day activities comply with the HIPAA Privacy Rule.
  2. Designate a privacy officer and a security officer.
  3. Implement effective training programs.
  4. Ensure channels of communication exist to report violations and breaches.
  5. Monitor compliance at floor level so poor compliance practices can be nipped in the bud.
  6. Enforce sanctions policies fairly and equally.
  7. Respond promptly to identified or reported violations, and breaches.

 

How To Become HIPAA Compliant

The best HIPAA compliance softwareYou can also read more about the background and history of the Seven Elements here. You might consider using HIPAA compliance software which has been designed to use the seven elements framework and can simplify and automate compliance, and provides comprehensive risk management processes.

Step 1: Why HIPAA Privacy Rule Policies and Procedures?

Although HIPAA compliance consists of complying with all relevant Administrative Simplification Regulations, implementing HIPAA Security Rule and Breach Notification standards is generally an organizational process not connected with cultivating a culture of compliance. Additionally, the most common HIPAA violations are attributable to failures to comply with the HIPAA Privacy Rule.

However, it is no longer sufficient to develop policies and procedures that only address permissible uses and disclosures, the minimum necessary standard, and patients’ rights. Covered entities should ensure HIPAA Privacy Rule policies and procedures include how to explain to patients what PHI is (and what it isn’t), how to verify an individual’s identity, and how to record requests for privacy protections.

Step 2: The Roles of HIPAA Compliance Officers

It is interesting that the HHS’ Office of Inspector General placed this “tip” in second place after the development of policies and procedures. This would imply the roles of HIPAA compliance officers are to train members of the workforce, monitor compliance, and enforce the organization’s sanctions policy. However, there is quite a lot more involved in being a compliance officer.

In most cases, the HIPAA Privacy Officer will be the point of contact for members of the public and members of the workforce that want to report privacy concerns. Security Officers are generally more responsible for conducting risk assessments, ensuring security solutions are configured properly, and training members of the workforce on how to use the solutions compliantly.

Step 3: What Makes an Effective Training Program?

The effectiveness of the training provided to members of the workforce can make the difference between ticking the box of compliance or cultivating a culture of compliance. To make HIPAA Privacy Rule training effective, members of the workforce must understand what PHI is, why it has to be protected, and the consequences to patients, employers, and themselves of HIPAA violations.

HIPAA Security Rule training must be focused on protecting PHI in all formats and even more focused on the consequences of taking shortcuts, circumnavigating safeguards, and failing to alert managers of a data breach for fear of “getting into trouble”. One way of achieving this is to ask members of the workforce to run personal online credentials through the HIBP database to illustrate the importance of unique, complex passwords.

Step 4: The Importance of Two-Way Communication

While policy making and training has to come from the top down, it is important that any channels of communication relating to HIPAA compliance are also bottom up – not only to raise compliance concerns or report HIPAA violations, but also to provide feedback on what works and what doesn’t on the ground floor, and what new challenges are facing frontline members of the workforce.

This is why it can be important – when resources allow – to have a compliance team consisting of team members that have worked in or have knowledge of how different departments operate. For example, a compliance team consisting solely of lawyers and IT managers may not appreciate the difficulty of protecting the privacy of PHI in front of a grieving family mourning a recent loss.

Step 5: How Most Poor Compliance Practices Develop

Most poor compliance practices result from well-meaning intentions – for example, to “get the job done” or provide a good service to a patient’s family. When minor violations are allowed to continue, poor compliance practices can develop into a culture of non-compliance. This is why it is important to identify and address poor compliance practices at the earliest opportunity.

While it is important to have eyes on compliance at floor level, it is also important not to take eyes off compliance at higher levels. Busy managers and senior managers can also be guilty of taking shortcuts with compliance or ignoring non-compliant activities because they do not have the time to “sort it out” – when, in truth, the failure to take action is a failure of management.

Step 6: The Best Sanctions are Not Always Disciplinary

Sanctions policies can often be overwhelming documents threatening all manner of disciplinary actions for non-compliance from warnings to suspensions, to termination of contract and loss of license. Some even include the maximum federal penalties for violations of §1177 of the Social Security Act (up to ten years in prison and up to $250,000 in fines).

Although these sanctions may have to legally be included in a sanctions policy, making them the focus of attention is not necessarily the best way to cultivate a culture of compliance. The threat of a loved one being the victim of medical identity theft and the consequences of data breaches can encourage workforce compliance more than the threat of refresher training.

Step 7: Responding Quickly is the Key to Compliance

One of the keys to cultivating a culture of compliance is to respond to queries, issues, complaints, reports of violations, and data breaches as quickly as possible. Responding quickly to any type of communication demonstrates a commitment to compliance and an eagerness to ensure – once a compliant workforce is achieved – the compliant state is maintained.

Responding to queries, issues, complaints, etc. would ordinarily be the responsibility of compliance officers (or teams), but this can lead to the compliance officers being overwhelmed. Consequently, it may be necessary for managers and senior managers to take some responsibility for monitoring compliance and responding to workforce or patient communications.

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