How To Be Hipaa Compliant – Data security is a critical concern for health technology companies. As more and more companies outsource their technology solutions to Europe, compliance with US healthcare data security regulations has become a top priority.
For US-based healthcare companies, HIPAA compliance is mandatory when handling patient health information (PHI). When contracting with a third party, a HIPAA-compliant US entity must sign a Business Association Agreement with each entity to which it plans to provide access to PHI. While the BAA regulations in the US are fairly straightforward, the issue falls into a gray area when it comes to dealing with non-US entities.
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HIPAA’s lack of an explicit extraterritorial connection is a concern for US healthcare providers, as the offshoring of healthcare data by BAs is common. Server farms, call centers, data analysis, transcription services, software developers with access to PHI are physically and legally located overseas.
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When it comes to EU-based organizations, the risk of handing over PHI to foreign BAs has been somewhat mitigated by the introduction of the General Data Protection Regulation. Although the Regulation legally covers the data protection and privacy of EU citizens and residents, it serves the larger purpose of protecting private data in general. The GDPR was introduced with the main objectives of giving individuals control over their personal data and simplifying the regulatory environment for international businesses by unifying regulation within the EU.
In comparison, HIPAA and GDPR have many similarities. It can be argued that the European regulation is thorough and strict as it deals with every personal data, but it offers special provisions when it comes to health data. In the EU, any information “relating to the physical or mental health of an individual” is health data, including the provision of services that disclose information about a person’s health status. This data is subject to more stringent regulation under the GDPR than other types of personal information. Among other things, the subject’s “express consent” is required to process his or her health data.
HIPAA is defined to regulate covered entities—healthcare providers, health plans, and clearinghouses—and extends to their contractual BAs. However, it does not extend statutory coverage to international organizations. GDPR requirements apply to all organizations that process personal data of individuals, regardless of whether the organization is established in the EU or elsewhere. This means that any company operating in the EU will fall under the GDPR’s strict rules when handling any type of personal data.
From a US entity’s point of view, dealing with EU-based BAs can be considered secure and a standard BA agreement would be sufficient to ensure appropriate data protection. As stated in Recital 14 of the GDPR, “The protections provided for in this provision shall apply to individuals regardless of their nationality or residence with respect to the processing of their personal data.” It extends the protection of sensitive data, including health data, beyond EU residents, as it refers to “persons” without specifying their nationality or place of residence.
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The GDPR has forced all EU entities to strengthen security measures for the storage, access, transfer and access to personal data. All activities and actions related to data security are monitored and resolved by a data protection officer, who should be appointed by any company that processes large amounts of confidential data. All EU companies have taken additional measures to ensure data security, train employees and ensure full compliance.
GDPR compliance must be properly documented and proven. The regulation is based on the full responsibility of both controllers and data processors. Here, too, European regulations and HIPAA compliance measures largely overlap. The roles of the HIPAA Compliance Officer and the DPO involve similar responsibilities. A HIPAA-compliant company’s relationship with its BA is defined in the same way as a GDPR data controller’s relationship with a processor.
Under current EU law, both the data processor and the controller are liable for breaches of the GDPR. this applies to claims for damages by the data subject as well as fines by the regulator.
Less serious violations can result in fines of up to €10 million or 2% of the company’s global annual revenue, whichever is higher. million, or 4% of a company’s global annual revenue, whichever is higher, although fines for HIPAA violations are calculated differently than GDPR, the European regulator takes the issue very seriously and certainly feels the offending party’s pain. . fine. The severity of the penalty is not only an effective deterrent, but also serves as an incentive for companies to work to improve data security through compliance.
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Software providers, development companies, application developers form the front line of information security in Europe. Even before GDPR came into effect, software vendors made the safety and security of entrusted data a top priority. For most companies, introducing new requirements was a matter of adapting existing processes to the regulation. Software production is subject to data theft, hacking, breaching and other data security risks. Therefore, it is very important to maintain the current, high level of security. Software houses have vast experience and relevant resources for data protection solutions. Having IT experts at your disposal allows you to constantly fix and improve security without the need to hire third parties.
Data protection is important to developers and goes beyond internal policies and GDPR requirements. The security of the developed software, customer confidentiality, intellectual property – all require the highest level of security. When dealing with sensitive information such as health data, software houses introduce additional measures to ensure security. These include, but are not limited to: signing additional NDAs, additional employee training on the use of entrusted data, accidental access checks, hardware and software encryption, data copying and transfer restrictions, access restrictions, multi-level authorization.
As you can see, HIPAA and GDPR force companies to prioritize data security. The overlap of requirements and restrictions makes the European regulation a sufficient basis for considering the transfer of sensitive data to EU-based providers. This applies to PHI as well as other sensitive data because the GDPR was introduced with health in mind, not health. Regulation created an environment for international business and allowed for competition on prices and quality rather than focusing on trust issues.
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If you manage an independent medical practice, you may wonder if the time and money costs of compliance are really worth the cost of a failed audit or breach. To give you a broad idea, we’ve created two scenarios: a practice that has its HIPAA policy in place and adheres to it (and conducts periodic risk assessments) and a practice that doesn’t.
In our hypothetical example, Dr. Corey Compliant owns a practice that is a closed entity. He hires a medical professional to create a government-mandated HIPAA policy. It also brings in HIPAA-required contractors to install its IT and EMR.
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Was it money well spent? When the US Department of Health and Human Services (HHS) Office for Civil Rights (OCR) commissioned a HIPAA audit, Dr. It issues current HIPAA policies, risk assessments and compliance protocols. Its preparation minimizes the disruption of audit work. Being prepared also reduces her stress because she has nothing to hide. He decides to hire a lawyer to advise him on the process, but since his documents are in good order, the legal fees are modest.
When Dr. However, Dr. Thus, his fines remain low.
But what about a breach of privacy or security? Penalties for violations are determined in part by the degree of negligence. Dr. Compliant’s documentation helps him demonstrate that there was a violation
At some point, when a doctor decides to sell his practice, his regulatory compliance record will affect the buyer’s price. The sale price likely reflects its stellar reputation and operational strength.
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