The healthcare industry is known for the complexity of its regulatory and compliance requirements. Every startup must meet or exceeds these standards.
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When it comes to healthcare, regulatory compliance is absolutely essential in ensuring that your business fulfills legal obligations and protects the privacy of your patients. It’s non-negotiable, and by abiding by healthcare regulatory requirements, you can avoid costly fines and heavy blows to your reputation. Admittedly, many healthcare practitioners shy away from discussing regulations and compliance, as it can feel very overwhelming and quite daunting at times. However, with the right resources, and with our healthcare startup guide, you can ensure you acknowledge and respond to every compliance standard with ease.
Many healthcare startup businesses fail because, quite simply, they don’t recognize the importance of adhering to regulatory compliance in healthcare. Failing to acknowledge healthcare regulations can result in fines from anywhere between $50,000 and $1.5 million, as well as resulting in a very damaged reputation that can be difficult to bounce back from. You certainly don’t want clients to have the wrong impression of your business, and you need to start off on the right foot, with healthcare regulations playing a large role in this. This is especially important when it comes to healthcare, as you’re dealing with a variety of private health data that is highly personal to every patient. Having the appropriate security measures in place, including the use of a secure data warehouse, is absolutely critical, and provides your patients with peace of mind when it comes to their information. It ensures that you’re legally compliant, and it also reduces the risks of running into problems with the governing regulatory bodies that are continually monitoring and assessing the operations of healthcare entities.
Now that you’re aware of the significance of regulatory compliance and why healthcare data security solutions are important, there are some notable standards that you should become familiar with. Doing so allows you to fulfill your legal obligations, and avoid run-ins with governing bodies, and is part of almost every essential business plan for healthcare startups.
This regulator concerns the handling of pharmaceutical drugs, food supplements, vaccines, as well as cosmetic products. You may be surprised to know that the FDA also covers the authority of medical device use, in addition to disease-related issues.
CMS focuses on subsidized medical coverage across a variety of programs including Medicare, Medicaid, and SCHIP, or the State Children’s Health Insurance Program. It’s a very popular standard that coincides with HIPAA compliance protection.
As the name states, this standard enforces regulations that pertain to the environment and human health. It ensures that you’re abiding by ecological and sustainable practices for the bettering of the business world.
The HHS is a host to several different healthcare regulation agencies, including the previously mentioned, in addition to the Agency for Healthcare Research and Quality (AHRQ). This ensures that health needs are recognized and that all research prioritizes patient safety and acknowledges healthcare implications.
As the final regulator that you should be aware of, the CDC monitors health threats from various infectious diseases. However, the CDC is also concerned about environmental issues in addition to birth defects, injuries, violence, and other emergency responses.
In recognition of the key regulators, it’s high time that you’re aware of the most essential regulations within US healthcare to ensure you maintain compliance and regulatory standards. Educating yourself in these areas is one of the most important tips to succeed in a healthcare startup, and is a great way to overcome common revenue challenges.
One of the most influential regulations, that you’ve likely heard of before, is HIPAA, which sets national security and privacy standards for healthcare information. It concerns the handling of protected health information (PHI), and also outlines what occurs in the case of healthcare security violations and breaches. HIPAA ensures that all risk analysis and management systems are up to date, and can handle the production and storage of data across departments. It also ensures that only authorized users have access to specific information, which significantly reduces the chances of information being leaked or hacked.
The Stark Law prohibits healthcare providers and organizations to refer patients to any external entity that highlights a financial relationship outside of Medicare. Medicare takes care of many healthcare services, and so this law can clarify reimbursement operations and processes, with a financial relationship pertaining to any business owned by a provider.
This statute prevents fraud and cases of abuse in terms of healthcare, by highlighting ethical practices that must be undertaken. It prohibits the use of bribery, and in cases where this is found, healthcare organizations may come under fire and receive heavy fines.
This act is essential for providing immunity to healthcare organizations and individuals when the standard of care is being evaluated. This allows weaknesses to be identified in healthcare entities without fear of consequences.
Medicare is the most common US government health program that provides insurance to individuals 65 or older, as well as some younger citizens with disabilities. It allows access to healthcare, regardless of income, and is managed by the federal government.
Linked to medicare, Medicaid is managed by individual states and is based on income as opposed to age. It supports those with low incomes who have complex healthcare needs and often is what supplies long-term coverage.
As the name suggests, the CHIP program provides low-cost coverage to families and children who cannot qualify for Medicaid, but require support and insurance in the healthcare realm. Children must be age 18 or younger to receive reimbursement.
This is a value-based purchase program that aims to reduce avoidable readmission costs and increase the value of communication and coordination concerning patient engagement. It’s highly significant in lowering costs for healthcare organizations whilst prioritizing health.
One of the easiest ways to manage all your healthcare data and patient information is to use compliance software, such as Carepatron. With bank-level encryption embedded within the software, and round-the-clock security monitoring and measures, this type of software is quickly becoming the preferred option when it comes to health regulatory compliance. You can utilize data warehousing and predictive modeling to increase the accuracy of your business reports and operations, and streamline your operations without compromising legal obligations. Such software takes the hassle out of regulatory compliance, ensures that you’re following the complex health regulations, and sets you on the right path towards success in terms of your compliance responsibilities. Patients can have complete peace of mind knowing that their information is in safe hands and that you are constantly and continuously abiding by healthcare expectations and guidelines.
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