In times of cybercrime and data protection breaches, the IT Security in Medical practices increasingly important. The new IT security guideline in accordance with Section 75b SGB V ensures that sensitive patient data is protected against unauthorized access. This Guideline was approved by the National Association of Statutory Health Insurance Physicians (KBV) in cooperation with the Federal Office for Information Security (BSI) has been developed.

The IT security guideline translates the Specifications the General Data Protection Regulation (GDPR) into clear and practice-oriented Requirements for the Privacy in Medical practices. Through the Implementation These measures enable practices to ensure the security of confidential patient data and comply with legal requirements.

Key findings

  • The IT security guideline defines binding standards for the IT Security in Medical practices fixed.
  • It was developed by the KBV in agreement with the BSI developed.
  • The Guideline translates the DSGVO-Specifications into concrete measures for the medical sector.
  • Through the Implementation practices can use the Privacy and comply with legal requirements.
  • The KBV provides Implementation aids like Explanatory videos and sample documents.

What is the IT security guideline in accordance with Section 75b SGB V?

The General Data Protection Regulation (GDPR) regulates the handling of personal data throughout Europe, but until now there has been a lack of specific Specifications for medical practices. The IT security guideline in accordance with Section 75b SGB V was developed to close this gap.

Translation of the GDPR for medical practices

Its aim is to translate the provisions of the GDPR into clear and practicable Practical requirements to the IT Security to translate. This should enable doctors to Implementation data protection requirements and Legal certainty be created.

Purpose: Clear and practicable requirements for IT security

The IT security guideline defines binding standards and specific measures that medical practices can use to ensure the security of sensitive patient data. It translates the general Specifications of the GDPR into practicable Practical requirements for the medical sector.

Developed by the KBV in agreement with the BSI

The National Association of Statutory Health Insurance Physicians (KBV) developed the Guideline in agreement with the Federal Office for Information Security (BSI), the central cyber security authority in Germany. It therefore combines expertise from both areas - healthcare and IT security.

Which practice sizes and systems are affected?

The IT security policy contains five Attachments with different Requirementsdepending on the Practice size and equipment apply. The basis is Appendix 1, the specifications of which apply to all Practice types are mandatory.

Appendix 1: Requirements for all practice types

Appendix 2: Additional requirements for medium-sized practices

Medium-sized practices with more than 20 employees in the data processing area must also have the Requirements from Appendix 2.

Annex 3: Additional requirements for large practices

In addition to Annex 1, the extended requirements in Annex 3 also apply to large practices.

Appendix 4: Additional requirements for large medical devices

Practices that have large medical devices must comply with the specific Requirements from Appendix 4.

Annex 5: Requirements for decentralized components of the telematics infrastructure

Annex 5 regulates the IT Security for decentralized components of the Telematics infrastructure.

The exact definitions of the various Practice sizes and the detailed Requirements of the respective Attachments are defined in the directive.

Secure use of apps

The IT security policy contains precise Specifications for the safe handling of mobile apps in medical practices. To ensure a high level of App security some important aspects must be taken into account.

Only install apps from official stores

Only the installation of Apps from trustworthy App stores such as Google Play or the Apple App Store. Apps from unofficial sources pose increased security risks and should therefore be avoided.

Activate automatic updates

In order to always use the latest and most secure version of an app, the automatic update function must be activated. This ensures that security gaps are closed quickly and the Privacy kept up to date.

Avoid data outflow to third-party providers

In order to protect the confidentiality of sensitive practice data, only Apps that do not transmit data to third-party providers such as advertising companies or analysis services.

Encrypt local app data

Should be stored locally on the smartphone or tablet Data are stored, they must be stored in encrypted form to prevent unauthorized access.

Safety aspect Requirement
App sources Only official App stores
Updates Activate automatic updates
Data transfer No data transfer to third parties
Local data Encryption on the end device

IT security guideline in accordance with § 75b SGB V

The IT security policy places particular emphasis on controlling and minimizing app security risks.Authorizations. The Authorizations for mobile applications should be reduced to the absolute minimum necessary and their use carefully monitored. This serves to protect sensitive patient data from unauthorized access.

Minimization and control of app permissions

Furthermore, the use of Cloud-storage services such as iCloud or Google Drive are no longer permitted in medical practices. The directive prohibits the storage of confidential data in the Cloudto avoid security risks from third-party providers. Instead, local storage solutions must be used that comply with the strict Requirements to data security.

Dispensing with cloud storage

With regard to Web applications The IT security guideline prescribes a secure Authentication before. Access must be protected by at least a user name and password. In addition, an automatic logout is required after a certain period of inactivity to prevent unauthorized access.

Secure authentication for web applications

For medium-sized and large practices, additional safety requirements also apply with regard to Authorizations, Cloud-utilization and Authentication from Web applications. The exact specifications can be found in the corresponding Attachments of the directive.

Protection of confidential data

The IT security guideline places a special focus on the protection of confidential data in medical practices. Several specific measures are prescribed to ensure the security of this sensitive information.

No storage in the browser

One of the core requirements is that no confidential data may be stored in the browser. This prevents unauthorized persons from accessing this information on unattended computers.

Regular deletion of browser data

In addition, browser data such as history and cookies must be deleted regularly. This is the only way to ensure that any cached Confidential data permanently from the practice PCs.

Only use HTTPS connections

When transmitting confidential data via the Internet, for example to Web applicationsis a Encryption is mandatory. For this reason, all Internet connections in the practice must be via HTTPSthe secure hypertext transfer protocol. The integrity of the certificates used should always be checked in order to Browser security to ensure that

Firewall and access control

One of the central security measures of the IT security guideline concerns the protection of web applications in medical practices. According to the directive, practices that host such applications themselves must take additional security precautions to prevent unauthorized access and misuse.

Using firewalls for web applications

In order to effectively protect web applications from attacks from the Internet, the directive provides for the use of special Web Application Firewalls (WAF) before. These Firewalls monitor all data traffic to and from the web applications and block suspicious activities.

Protection against automated access

In addition to the Firewalls must Access control-mechanisms must be implemented that are specifically designed to protect against automated attacks such as brute force attacks. These include captchas, for example, where the user must prove that the access is human.

Implementing rights concepts for web applications

Furthermore, a well thought-out Rights management in the web applications is mandatory. Only authorized users should be able to access sensitive functions and data. The Access control is to be implemented by means of a role and authorization concept based on the need-to-know principle.

Security measure Description Purpose
Web Application Firewall Special Firewall for the protection of web applications Detection and defense against attacks
Captchas Security queries to differentiate between humans and bots Protection against automated access
Role-based Rights management Finely graduated authorization concept in web applications Access control according to the need-to-know principle

Further safety measures

The IT security guideline not only takes software security into account, but also regulates the physical security of end devices in medical practices. For example, certain measures must be taken to prevent unwanted access to microphones, cameras and screen content.

Prevention of unwanted microphone and camera access

Is the use of Microphone or Camera not required, these components must be deactivated or covered. This serves to protect against unauthorized recording and possible data protection violations due to unwanted access.

Screen lock during inactivity

To ensure that Confidential data not fall into the wrong hands, all End devices such as PCs, laptops and tablets via a Screen lock have. This automatically blocks access after a certain period of inactivity so that unauthorized persons cannot access the running systems.

These additional security measures are intended to ensure comprehensive protection of confidential data and information in medical practices. The consistent Implementation of the directive is of fundamental importance.

Implementation aids and resources

To help medical practices implement the new Requirements of the IT Security Guideline, the National Association of Statutory Health Insurance Physicians (KBV) and the Associations of Statutory Health Insurance Dentists such as the KVWL provide extensive Implementation aids and Handouts ready.

Information and examples from the KBV and KVWL

The KBV and KVWL offer practical tips and illustrative examples that make it easier for practices to interpret and implement the directive. These Handouts illustrate the specific requirements and show ways of practical implementation.

Sample documents and explanatory videos

In addition, the practices have Sample documents as templates and Explanatory videos on various IT security topics. These audiovisual aids explain the requirements in an understandable and practical way.

Contact points for questions and support

If you have any questions or need support, doctors can contact the Contact points of the KBV, KVWL and other bodies. They will receive competent advice and help with the professional implementation of the IT security guideline.

Conclusion

With the IT security guideline according to §75b SGB V the National Association of Statutory Health Insurance Physicians (KBV) has taken an important step towards strengthening the Patient data protection in Medical practices undertaken. The uniform and binding standards defined therein for IT Security practices can now ensure the security of sensitive patient data while complying with legal requirements.

Despite the administrative burden involved in implementing the new requirements, this is a significant step towards increasing patient confidence in the Privacy to strengthen. Legal certainty and responsible handling of sensitive data are essential for Medical practices of utmost importance to protect the privacy of their patients.

Fortunately, the KBV and the Kassenzahnärztlichen Vereinigungen (KVen) provide extensive aids such as Handouts, sample documents and Explanatory videos ready to Medical practices at the IT Security support. These resources facilitate the practical implementation of the directive and provide Contact points for questions and support.

FAQ

What is the IT security guideline in accordance with Section 75b SGB V?

The IT security guideline in accordance with Section 75b SGB V translates the requirements of the General Data Protection Regulation (GDPR) into clear and practicable measures for IT security in medical practices. It was developed by the National Association of Statutory Health Insurance Physicians (KBV) in consultation with the Federal Office for Information Security (BSI).

Which practice sizes and systems are affected?

The IT security guideline contains five annexes with different requirements depending on practice size and equipment. Appendix 1 applies to all practice types. Annexes 2 and 3 contain additional requirements for medium-sized and large practices respectively. Annex 4 regulates requirements for large medical devices, and Annex 5 regulates IT security for decentralized components of the telematics infrastructure.

What are the requirements for the use of apps?

Only apps from official app stores may be installed. The automatic update function must be activated. To avoid data leaks, only trustworthy apps should be used without passing on data to third parties. Data stored locally on the smartphone must be encrypted.

How does the directive regulate the handling of web applications?

App permissions must be reduced to a minimum and controlled. The use of cloud storage services must be avoided. Secure authentication and automatic logout after inactivity are mandatory for access to web applications. Additional security requirements apply for medium-sized and large practices.

What measures does the directive prescribe for the protection of confidential data?

No data may be stored in the browser and the browser history and cookies must be deleted regularly. All internet connections to web applications must also be encrypted using the secure HTTPS protocol. The integrity of the certificate should be checked.

What are the requirements for operating your own web applications?

Practices that host their own web applications must use special web application firewalls (WAF) and mechanisms to protect against automated attacks. A rights concept for access control in the web applications is also required.

What other safety measures are prescribed?

Microphones and cameras must be deactivated or covered when not in use. An automatic screen lock is also required after a certain period of inactivity to prevent unauthorized persons from gaining access to confidential data.

What assistance is available for implementing the directive?

The National Association of Statutory Health Insurance Physicians (KBV) and the Associations of Statutory Health Insurance Dentists (Kassenzahnärztliche Vereinigungen) provide extensive resources such as tips, examples, sample documents and explanatory videos. Doctors can also contact special contact points if they have any questions.
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