A Complete Guide to Healthcare Compliances

Global healthcare is a trillion-dollar industry, and the US has been at the forefront for decades. It establishes international healthcare agencies and influences healthcare policy to address chronic health threats such as HIV/AIDS, malaria, and tuberculosis. The US has also been the pioneer of medical innovation and digital transformation in healthcare for the last few years.

These changes have led to the implementation of many new rules, regulations, and legislation, making healthcare compliance a dire necessity for medical institutions. These compliances are for everything: following safety protocols, delivering quality care, protecting confidential health information, coding medical billing systems, and much more.

This blog will discuss the importance of healthcare compliance and the risk of non-compliance. We will also outline the essential regulations and laws that you must consider when developing a healthcare application.

What is Healthcare Compliance?

Healthcare compliance is a broad term that involves the extensive efforts of medical organizations to ensure they have robust security measures, processes, and protocols to prevent fraud, abuse, and misuse of anything within their business processes. Having standard and secure procedures ensures that organizations meet the professional, ethical, and legal obligations imposed by various healthcare-related regulations.

For instance, if a medical association implements strict data privacy to store, protect, and dispose of patients’ personal medical information, it demonstrates that the organization adheres to laws, guidelines, regulations, and compliances applicable in the industry.

Healthcare compliance laws are highly complex and subject to frequent change, often involving operational and workflow changes, internal audits, ongoing advancements, IT compliance updates, and more. Infringement of regulatory compliance in healthcare can lead to legal punishment, including federal fines.

It is why, healthcare companies have dedicated team members who specifically focus on regulatory compliance. According to the Bureau of Labor and Statistics, the overall need for compliance officers is projected to grow by 8% from 2016 to 2026. Not to mention, ensuring compliance in the healthcare industry requires collaboration between legal professionals, compliance officers, and software development companies like Appinventiv to create robust and compliant healthcare solutions.

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What is the Purpose of Healthcare Compliance?

Compliance in healthcare covers a wide assortment of practices pertaining to all medical institutions, both large and small. Regulatory compliance in healthcare is a holistic approach that includes healthcare governance, risk management, and compliance (GRC) essential to creating a secure and high-performing environment.

The key purpose of making medical associations comply with the GRC is to improve patient care. However, most of the healthcare regulations and compliance also focus on patient security, data privacy, and medical billing.

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Why is Compliance Important in Healthcare?

Healthcare compliance is critical because it focuses on patients’ safety, quality care, and data privacy. Also, penalties for noncompliance are steep, bringing in lawsuits, hefty fines, or even loss of licenses. In some scenarios, the consequences of not complying with the regulations are life or death, as a small mistake can have dire outcomes on patient health, care coordination, data protection, and safety.

Adhering to digital health compliance can help protect against potential cybersecurity threats or data breaches.

Healthcare cybersecurity compliance ensures that everyone in the industry follows GRC guidelines and understands expectations while providing safe and high-quality care. Medical practitioners who don’t follow legitimate procedures can end up harming a patient or another staff member.

What are Some Examples of Healthcare Compliance?

Digital health compliance has elaborative strictures pointing out the dos and don’ts for Health Information Technology (HIT), personalized prescriptions, wearable technology, and telehealth. Healthcare mobile apps are one of the most common ways of delivering medical services, especially during and after the pandemic. There are many regulatory compliance standards in healthcare that organizations should adhere to. Here are some of the most common healthcare compliance examples:

Health Insurance Portability and Accountability Act (HIPAA)

This act is enforced by the Office for Civil Rights (OCR) within the US Department of Health and Human Services. HIPAA ensures the security and privacy of eligible health-related data and, in particular cases, prevents the risk of data breaches. Failing to abide by HIPAA could result in hefty penalties ranging from $100 to $50,000 per violation, depending on the level of culpability.

To help you save from paying such penalties, we develop secure HIPAA-compliant health apps that protect sensitive medical information related to patients, hospitals, and doctors.

Federal Trade Commission (FTC) Act

FTC imposes regulatory protocols to deal with unfair claims, data security, data privacy, malpractices in businesses, and other related challenges. This act covers the unfounded claims about the usage of a mHealth app. FTC’s Health Breach Notification Rule mandates healthcare IT consulting firms to report data breaches such as personal health records.

Federal Food, Drug, and Cosmetic (FD&C) Act

The Food and Drug Administration implements this act to ensure medical devices and applications qualify standard guidelines and are safe to be used by the masses. Remember, not all healthcare apps fall under this jurisdiction; only those that fail to deliver on claims and pose serious consequences to consumer health are subject to the FD&C Act.

HL7 Standards

Health Level Seven International (HL7) is a non-profit organization accountable for setting industry benchmarks for exchanging, integrating, sharing, and retrieving electronic health information that enables procedural medical practice.

We at Appinventiv follow the set of international standards for using healthcare information as dictated by HL7 standards.

The HITECH Act

The Health Information Technology for Economic and Clinical Health (HITECH) Act was introduced in 2009 during the regime of President Barack Obama. The act aims to promote the enterprise adoption of Health Information Technology through Electronic Health Records (EHRs). The administration also tightened the loose ends around the HIPAA Act of 1996, following which it became mandatory for healthcare businesses to inform users if and when their credentials were compromised.

We ensure that all mHealth apps we develop abide by the HITECH Act and can successfully pass all the security audits, ensuring strict enforcement of the HIPAA privacy and security rules.

Bring Your Own Device (BYOD)

The Bring Your Own Device (BYOD) is a conceptual practice where healthcare organizations allow medical staff to use personal devices like smartphones and tablets for official duties. However, things could go downhill if your mHealth solution is not customized for BYOD security protocols.

Imagine a scenario where an employee loses his/her smartphone with access to critical Protected Health Information (PHI). It is where a strongly thought-out mobile device management (MDM) strategy comes into play. When the developers build the mHealth solution with remote wipe capability, you can easily erase the data associated with the lost device, including emails and browsers. Taking note of such minutiae during the initial SDLC stages could help companies procure a BYOD approval eventually.

We at Appinventiv ensure you deliver BYOD-friendly mHealth solutions as our efficient tech experts implement an MDM strategy into the applications that help organizations control PHI in real-time.

GDPR

The General Data Protection Regulation (GDPR) applies to smartphone applications that collect and process customer data of European Union citizens. Privacy protection is the essence of GDPR, through which the federal authorities have attempted (with success) to hand over some control of personal data to the layman. It also keeps business practices pertaining to private data management out in the open.

We at Appinventiv follow the stringent GDPR compliance in healthcare to ensure that every data that your application works with is highly secure.

SaMD

The International Medical Device Regulators Forum (IMDRF), a global coalition that advocates systematic governance of medical devices, formulated the Software as a Medical Service (SaMD) to introduce actionable guidance to support the advancement of digital technologies in this segment. Headed by the FDA itself, the group has documented a plethora of frameworks on risk categorization, quality management systems, and clinical evaluation.

Our developers sternly follow the concepts and SaMD risk categories detailed by IMDRF for mHealth app development.

Food and Drug Administration (FDA)

Food and Drug Administration, a key component of the US Department of Health and Human Services, regulates the development, manufacturing, efficacy, safety, and marketing of pharmaceuticals, medical devices, and biologics. Compliance with FDA regulations is crucial for patient safety and product effectiveness.

We at Appinvetiv focus on building mHealth applications and software with all the essential characteristics that make them FDA-compliant.

Stark Law (Physician Self-Referral Law)

Stark Law prohibits physicians from referring patients to receive designated health services payable by Medicare or Medicaid from entities with which the physician or an immediate family member has a financial relationship. This law aims to prevent physician self-dealing while allowing for legitimate healthcare arrangements.

Emergency Medical Treatment and Labor Act (EMTALA)

EMTALA requires hospitals to provide emergency medical care to anyone, irrespective of their ability to pay or insurance status. This law prevents patient dumping while making emergency treatment accessible to everyone.

We at Appinventiv build YouCOMM, an in-hospital patient communication app that provides a revolutionary solution to the widespread issue of patient-caregiver by providing real-time access to medical help. By developing a multi-request format platform that connects patients with nurses to get help for their basic needs, we solved the issues of patients’ assistance wait time during emergencies. The result? The app was awarded the CT Bioscience Innovation Fund and an Entrepreneurs Innovations Award in 2019. Currently, 5+ US hospital chains are running on the YouCOMM solution, and 3+ hospitals are getting high CMS reimbursement.

These healthcare compliances are in force and focus on maintaining the integrity of the healthcare system, protecting patient rights, ensuring quality care, and preventing fraudulent practices. Healthcare organizations must adhere to these laws to remain compliant and avoid legal repercussions.

Anti-Kickback Statute

This law prohibits the exchange of remuneration, such as kickbacks or bribes, for patient referrals or services covered by federal healthcare programs like Medicare and Medicaid. This law aims to prevent the influence of financial gain on medical treatment decisions.

False Claims Act (FCA)

The False Claims Act makes it illegal and punishable to file a false claim for the federal program. Under FCA, private individuals (whistleblowers) can file lawsuits on behalf of the government, offering financial incentives for exposing fraudulent activities.

How Can Appinventiv Help You Follow the Regulatory Requirements of Healthcare Compliance?

Being a reputed healthcare software development company, we specialize in creating mobile applications and software solutions that comply with industry laws and regulations. We have a proven track record of working with 75+ digitization projects and 13+ awards that demonstrate our efficiency in developing healthcare compliance solutions. With 8+ years of industry experience and a team of 180+ healthcare nerds, we are fully equipped to care for your healthcare compliance needs. We can help you be healthcare-compliant in several ways:

Secure Healthcare Software Development

Our efficient tech experts develop cutting-edge healthcare solutions with a strong focus on security and data protection. They can implement encryption, authentication, and access control features to help healthcare organizations comply with HIPAA and other data privacy regulations.

Telehealth Solutions

We build mHealth and telemedicine applications that adhere to the regulatory requirements specific to the healthcare industry. All our applications and software can facilitate remote patient care while staying within legal boundaries.

We also build training and educational apps that educate employees about relevant regulations and best practices while delivering compliance-related content to healthcare professionals and patients.

Healthcare Compliance Consulting

While not a legal service provider, we also offer data security and healthcare compliance consulting, helping healthcare professionals implement robust security measures to prevent data breaches and adhere to healthcare compliance laws.

Software Integration

At Appinventiv, we build state-of-the-art healthcare applications that can be integrated with specific medical devices to ensure an easy flow of data between the systems, making it easier for healthcare associations to manage compliance-related tasks.

For instance, we built a Health-e app, a concentrated platform that integrates traditional medical data from appointments, laboratory results, imaging, and clinical data with wellness information collected from personal sensors. This includes data on sleep patterns, physical activity, weight, blood pressure, and other pertinent health metrics.

Electronic Health Records (EHR)

All our apps can seamlessly connect with your existing electronic health record (EHR) systems, ensuring patient data adheres to healthcare compliance laws. We can also help you build HIPAA-compliant EHR from scratch that allows all medical parties, pharmacists, and patients to view and share patient’s medical information safely.

Compliance Auditing and Monitoring Solutions

Our extensive range of healthcare compliance services also includes developing auditing and monitoring tools that help healthcare organizations monitor and audit their compliance efforts. These tools can efficiently track access to patient data, flag potential violations, and generate reports to demonstrate compliance.

Final Thoughts

The national healthcare expenditure in the US is poised to hit $5.7 trillion by 2026, primarily driven by the integration of healthcare trends like mHealth, telemedicine, wearable technology, sensors, and remote monitoring tools. These healthcare developments represent a remarkable advancement in medical solutions to establish rapid and unprecedented connections with the general masses.

Keeping pace with this rapidly evolving industry while leveraging emerging technologies like AI, ML, IoT, AR/VR, Blockchain, etc., and ensuring adherence to healthcare compliance can be an uphill task for many organizations.

Let Appinventiv stand by you as your trusted tech partner and provide the best-in-class healthcare software development services to take your business to greater heights safely and successfully.

Want to know more about our healthcare compliance software solutions services? Get in touch with our experts today.

FAQs

Q. How to ensure compliance in the healthcare industry?

A. To adhere to healthcare compliance, medical associations should have a proper plan in place, which includes following the below-listed practices:

• Develop clear policies for every component of compliance.
• Designate a compliance officer.
• Educate employees about common compliance risks in healthcare.
• Conduct compliance audits.
• Deal with noncompliance immediately.

Q. What are the benefits of a compliance program in healthcare?

A. Healthcare settings can greatly benefit from an effective compliance program. For instance, it helps organizations:

• Ensure adherence to a complex list of healthcare regulations and policies
• Reduce the risk of serious consequences such as fines, penalties, and criminal charges.
• Protect patient data and privacy, fostering compliance with HIPAA and other data protection laws.
• Detects and prevents healthcare fraud
• Minimizes financial losses and legal consequences.
• Mitigates common compliance risks in healthcare
• Secures the organization’s reputation and long-term credibility in the industry.
• Promotes a culture of quality care and safety, improving healthcare services and patient outcomes.

Q. What are compliance issues in healthcare?

A. Compliance issues in healthcare encompass a range of challenges related to adhering to healthcare regulations and compliance. Common concerns include patient data privacy (HIPAA), fraud prevention (Anti-Kickback Statute), proper medical billing (False Claims Act), and ensuring quality patient care while navigating complex healthcare compliance laws and policies.

Q. What is HIPPA in healthcare?

A. The US Department of Health and Human Services (HHS) has made country-wide standards known as the Health Insurance Portability and Accountability Act (HIPAA), which mandates industry-wide standards for the protection and confidentiality of patient health information.

THE AUTHOR

Dileep Gupta

DIRECTOR & CO-FOUNDER