As an insurer, you probably recognize the value of digital storage and workflow automation for business. Not only does it accelerate processing speeds and improve service; it makes the burden of regulatory compliance significantly easier. In order to meet regulatory standards, efficient data collection across the enterprise is critical. You need to be able to use that data when and where it is needed.
From HIPAA and Sarbanes Oxley to market conduct examinations, regulatory issues such as Solvency II, and more, mounting regulations continue to dictate the way we store information and conduct everyday business. Establishing clear policies that respond promptly to regulatory changes and implementing them effectively helps you to protect your leaders and your company. Still, you need immediate, thorough, and accurate audit trails to demonstrate your commitment to the policies you create.
The time-consuming measures you have to put in place to respond to increasing regulations can be frustrating, but they aren't avoidable. The regulations are not going to disappear; in the wake of numerous recent financial scandals and the ensuing economic crisis, they are expected to proliferate. The sooner you get a handle on your information, the better equipped you will be to survive public and private scrutiny from government, compliance officers, and auditors.
Here are a few tips to help you stay afloat in the turbulent sea of changing regulations:
Create a central repository for all of your information. Although digital capture and storage improves data quality and makes data access easier, faster, and more secure, 'going digital' alone is not enough. Electronic files should be stored in a single, central electronic document management (EDM) repository, or that repository should point to the location of files that are stored in multiple systems. This enables centralized queries and searches, rather than probing through multiple digital data silos when you need information quickly. It gives you and your auditors instant, detailed insight into your business transaction details.
Configure your document management system to restrict access to information in accordance with regulations and your internal policies. Make sure your system has the flexibility to let you define and limit access by business unit, department, a person's role or position, and individual. Make sure it can also prohibit access to specific pages within routine documents that contain sensitive information.
Take into consideration the enterprise-wide needs for the data within your documents that you weren't originally planning to catalog as you create a file indexing plan. The data may be vital to another department's or individual's process. Understand how people with diverse job functions search for information so you can make it quick and easy for them to find it when it's needed. Make sure any data they need to find from the files is included in your indexing plan. Making changes in the indexing scheme later in order to correct current oversights is very costly.
Take care that your enterprise search application fully integrates with your electronic storage repository. This helps you to guarantee a complete return of requested files and data. Otherwise, you may encounter errors and omissions as a result of poor interoperability between your document management repository and the search tools you use.
Choose an enterprise search application that lets you access data in structured forms and files as well as unstructured data stored in your repository, such as data stored in handwritten correspondence or emails. Comprehensive search will save you and your staff considerable time, and you will rest easier knowing that your queries aren't overlooking anything.
Make sure your system provides clear, structured data in an auditable format that will meet the needs of auditors and compliance officers. Electronic queries should provide details of all file access and business transactions involving digital media. This makes it easier to prove compliance with the information governance policies you establish and communicate.
Senin, 27 November 2017
Kamis, 16 November 2017
Regulatory Requirements Are Changing Everything for Healthcare Data Management
Enablement of the electronic records represents a major change for an industry that has been heavily dependent on paper based medical records for decades. The shift in data capture aims to increase efficiency in the delivery of health care services in several ways while reducing medical billing errors and instances of insurance fraud.
As you are aware, in addition to Electronic Records Management and Meaningful Use Admissions, your practice is responsible for documenting compliance with vital IT security functions to help protect personal indefinable information of patient records. In addition, practices must document and demonstrate on-going compliance of Medical regulatory processes and procedures.
Professional associations strongly recommending a thorough review of your practice's HIPPA's and Meaningful Use compliance process and procedures. Reputable IT partners will provide a no-cost, on site consultation to review your Information technology processes and procedures and help you understand and maintain ongoing regulatory compliance.
Your provider should have expertise in:
Network Security
Desktop Security
Secured communication through email, and IM
Disaster Recovery, Network redundancy and Collocation services
Data storage security
Hosted PBX / VoIP Systems
As part of their review, they should provide you with a comprehensive outline of the areas that require additional attention and note those areas where your compliance requirements have already been met.
Health providers have historically been restrained with administrative investments in IT infrastructure and personnel. This has produced a status quo of making due with limited technology resources. A reliance on outdated, disparate and fragmented computer systems further hampers an ability to easily store, access, and use patient data in the most productive ways.
Fortunately, services-based technology is taking the place of heavy investments once ubiquitous with administrative IT operations in most all clinical settings. These costs are knowable and can be budgeted for far less than managing in-house equipment and skilled professionals would cost. Further, regulatory compliance has become a part of the technology providers' core competencies, helping them become a partner to help manage this crucial aspect of clinical operations.
Maintaining security, regulatory compliance and managing administrative costs can best be managed through a partnership with a reliable service partner. Clinicians should be focused more on the quality of care they provide without being hampered by unknown technical issues and compliance gaps that, if left unchecked, can invite larger problems in the future.
Consider selecting a reputable provider already working with a professional association as a trusted partner. This relationship demonstrates a level of performance for the IT partner and their commitment to meeting the demands of the specialty clinical environment.
As you are aware, in addition to Electronic Records Management and Meaningful Use Admissions, your practice is responsible for documenting compliance with vital IT security functions to help protect personal indefinable information of patient records. In addition, practices must document and demonstrate on-going compliance of Medical regulatory processes and procedures.
Professional associations strongly recommending a thorough review of your practice's HIPPA's and Meaningful Use compliance process and procedures. Reputable IT partners will provide a no-cost, on site consultation to review your Information technology processes and procedures and help you understand and maintain ongoing regulatory compliance.
Your provider should have expertise in:
Network Security
Desktop Security
Secured communication through email, and IM
Disaster Recovery, Network redundancy and Collocation services
Data storage security
Hosted PBX / VoIP Systems
As part of their review, they should provide you with a comprehensive outline of the areas that require additional attention and note those areas where your compliance requirements have already been met.
Health providers have historically been restrained with administrative investments in IT infrastructure and personnel. This has produced a status quo of making due with limited technology resources. A reliance on outdated, disparate and fragmented computer systems further hampers an ability to easily store, access, and use patient data in the most productive ways.
Fortunately, services-based technology is taking the place of heavy investments once ubiquitous with administrative IT operations in most all clinical settings. These costs are knowable and can be budgeted for far less than managing in-house equipment and skilled professionals would cost. Further, regulatory compliance has become a part of the technology providers' core competencies, helping them become a partner to help manage this crucial aspect of clinical operations.
Maintaining security, regulatory compliance and managing administrative costs can best be managed through a partnership with a reliable service partner. Clinicians should be focused more on the quality of care they provide without being hampered by unknown technical issues and compliance gaps that, if left unchecked, can invite larger problems in the future.
Consider selecting a reputable provider already working with a professional association as a trusted partner. This relationship demonstrates a level of performance for the IT partner and their commitment to meeting the demands of the specialty clinical environment.
Selasa, 31 Oktober 2017
Reason for Medical Device Regulatory Compliance Being a Business Decision
The US Food and Drug Administration noticed frequent complaints of a permanent birth control mechanism called Essure. A medical group from Weill Cornell Medicine in New York registered a 10 times higher occurrence of reoperation during the first year of implantation. In Europe, the PIP breast implant remains a permanent scandal. The question here is why are approved devices causing serious safety concerns in the market? Clearly, strict regulatory oversight does not avoid the rise of malfunctioning medical devices. On the device manufacturer side, following the regulations alone does not assure all safety, quality and effectiveness parameters have to be addressed.
Essure, produced by Bayer, was approved via the 510(k) process. This route excludes medical devices from clinical testing if they are proven to be considerably equal to a similarly marketed instrument. As a result, any clinical data achieved from abbreviated studies would be insufficient to give valid and representative conclusions about safety of devices and performance. Should Bayer have conducted a full randomized, blinded clinical investigation instead? The answer to this should be derived from sensible business based decision-making, and not a general one. Completely understanding the features of the product from both profit and risk perspectives is an important keystone of the value proposition for medical devices. The base customers of medical devices are the end-users and/or patients whose requirements should rightfully take higher priority above regulatory rules.
Essure, produced by Bayer, was approved via the 510(k) process. This route excludes medical devices from clinical testing if they are proven to be considerably equal to a similarly marketed instrument. As a result, any clinical data achieved from abbreviated studies would be insufficient to give valid and representative conclusions about safety of devices and performance. Should Bayer have conducted a full randomized, blinded clinical investigation instead? The answer to this should be derived from sensible business based decision-making, and not a general one. Completely understanding the features of the product from both profit and risk perspectives is an important keystone of the value proposition for medical devices. The base customers of medical devices are the end-users and/or patients whose requirements should rightfully take higher priority above regulatory rules.
Rabu, 11 Oktober 2017
How To Bring Database Management In Tune With Regulatory Compliance
New regulations regarding financial controls and statements have necessitated an overhauling of collection, retention and management procedures as far as information is concerned.
What is Regulatory Compliance?
Regulatory Compliance Acts make it mandatory for public companies to evaluate, review, restructure and make a detailed report of the internal controls in place for financial statements. The report has to be given a "clean chit" by external auditors. These Acts seek to prevent financial misstatements, and reduce fraud in public companies.
Data Management:
IT is an important tool when it comes to data management to ensure regulatory compliance. IT tools are used for accessing and maintaining records, and protecting the financial systems from misuse. Here are some tips to ensure good data management practices.
1) The appropriate management must be notified of data management ownership and they must understand their responsibilities.
2) Data systems should be listed, their managers notified, and the number of databases, types of information software used, the underlying operating system, access conditions, and other utilities should be listed.
3) Review the potential threats to information stored in databases, and call for periodic reassessments.
4) The data should be properly catalogued, so extraction and tracking become easier.
5) There should be data backup in place.
6) The responsibilities regarding database management must be delegated in a way that it prevents unauthorized access to information, as well as alterations to the data.
Database Management: Database Administrators.
In order to ensure regulatory compliance, database management is broken up into different tasks and each task is delegated to a database administrator, or DBA. The DBA's responsibilities include:
1) Being accountable for the integrity of the data.
2) Authorizing and tracking database modifications and management of security of the system.
3) Ensuring proper backup for database.
4) Ensuring that the database is foolproof against unauthorized access.
5) Maintain a list of all databases, and databases other than their own that they access information from.
6) Keep proper documents in place establishing that they follow legal practices regarding access and privileges.
7) Test database log validation procedures.
8) Rectify the database quickly when unauthorized access and changes to the database are noticed.
9) Ensure that in case of an accidental or premeditated loss of data, it can be recovered in the minimum possible time so that business is not affected.
Database management procedures should satisfy auditors, be legal, and should employ correct auditing methods. There are companies that provide these services. However, they should be aware of their duties and responsibilities and ensure regulatory compliance of their database management processes. Upgrading the database system and putting in proper controls to information access and flow keeps the organization in the good books of auditors, and prevents financial scandals.
What is Regulatory Compliance?
Regulatory Compliance Acts make it mandatory for public companies to evaluate, review, restructure and make a detailed report of the internal controls in place for financial statements. The report has to be given a "clean chit" by external auditors. These Acts seek to prevent financial misstatements, and reduce fraud in public companies.
Data Management:
IT is an important tool when it comes to data management to ensure regulatory compliance. IT tools are used for accessing and maintaining records, and protecting the financial systems from misuse. Here are some tips to ensure good data management practices.
1) The appropriate management must be notified of data management ownership and they must understand their responsibilities.
2) Data systems should be listed, their managers notified, and the number of databases, types of information software used, the underlying operating system, access conditions, and other utilities should be listed.
3) Review the potential threats to information stored in databases, and call for periodic reassessments.
4) The data should be properly catalogued, so extraction and tracking become easier.
5) There should be data backup in place.
6) The responsibilities regarding database management must be delegated in a way that it prevents unauthorized access to information, as well as alterations to the data.
Database Management: Database Administrators.
In order to ensure regulatory compliance, database management is broken up into different tasks and each task is delegated to a database administrator, or DBA. The DBA's responsibilities include:
1) Being accountable for the integrity of the data.
2) Authorizing and tracking database modifications and management of security of the system.
3) Ensuring proper backup for database.
4) Ensuring that the database is foolproof against unauthorized access.
5) Maintain a list of all databases, and databases other than their own that they access information from.
6) Keep proper documents in place establishing that they follow legal practices regarding access and privileges.
7) Test database log validation procedures.
8) Rectify the database quickly when unauthorized access and changes to the database are noticed.
9) Ensure that in case of an accidental or premeditated loss of data, it can be recovered in the minimum possible time so that business is not affected.
Database management procedures should satisfy auditors, be legal, and should employ correct auditing methods. There are companies that provide these services. However, they should be aware of their duties and responsibilities and ensure regulatory compliance of their database management processes. Upgrading the database system and putting in proper controls to information access and flow keeps the organization in the good books of auditors, and prevents financial scandals.
Rabu, 27 September 2017
Wireless Network Regulatory Compliance and Security - Questions I Have Asked When Wi-Fi Is in Use
A couple of weeks ago, my nephew had a seizure. He's ok. We did all of the right things and got him the help that he needed. He eventually ended up at a local emergency room. While I was there waiting on the test results to get back, I started to take note of the technology the hospital was using. The biggest observation that I made is that they use Electronic Medical Records (EMR) -- no paper charts. Each observation room had its own computer and there were wireless mobile stations a few feet down the hall. So that led me to ask, "How compliant are they with HIPAA Standards in this wireless environment?"
Yesterday, I was at a local grocery store. I only picked up a handful of items, so I decided to use the self checkout aisle. Unfortunately, my terminal froze on one of the items I was trying to buy. I politely put my hand up to get the attention of the attendant, thinking that she was going to come over and do something to my terminal to get me going again. She didn't come to me. What she did instead was to pull out the stylus on her hand-held wireless computer, made a few taps and voila... I was up and running again. So that led me to ask, "How compliant are they with PCI Standards in this wireless environment?"
Now in two different scenarios, I've asked two questions. Both are the same question and focus on a single technology-wireless networks. The only difference is that I inserted a different standard. One primarily focuses on protecting Electronic Personal Health Information -- HIPAA, and the other primarily focuses on protecting credit card information -- PCI. The installation of a wireless network introduces a new set of issues that have to be addressed in order to be compliant with these standards.
What are some of these issues?
There is no physical medium by which your data is passed. With the data passing through the air, how do you contain access to it?
Traditional means to secure a wired network won't all work on a wireless network.
Attackers can attack a wireless network without having to go through an internet connection or firewall and remain anonymous.
So what are "some" security measures that could be put in place to address these issues and have a secure wireless network?
Make sure your data is encrypted if you handle sensitive information and/or that your wireless connection is encrypted. Even if someone is observing your signal, they won't be able to understand what they're viewing.
Make sure there is a method in place to authenticate each user as well as a method to authenticate the wireless network you're using. This is called mutual authentication.
Use a Virtual Private Network or a VPN whenever possible. If you have a wireless network connected to your wired network, you should be using a VPN.
Implement a Location-Based Wireless Security System. A Location-Based Wireless LAN security system gives you the ability to precisely determine the physical location of all wireless devices, in and around your RF environment. It continues to monitor your environment 24/7 and implements security protection mechanisms in real-time to address issues such as policy violations, rogue devices, vulnerabilities and threats.
Wireless networks are here to stay and should at least have the 4 security measure mentioned above in place. Wireless networks offer mobility, convenience and a relentless connection to the network, and it's something that every business (even those with a "No Wi-Fi Policy") is going to have to address, especially those that are subjected to standards like HIPAA, PCI, SOX, DOD Directive 8100.2 and GLBA, just to name a few.
Yesterday, I was at a local grocery store. I only picked up a handful of items, so I decided to use the self checkout aisle. Unfortunately, my terminal froze on one of the items I was trying to buy. I politely put my hand up to get the attention of the attendant, thinking that she was going to come over and do something to my terminal to get me going again. She didn't come to me. What she did instead was to pull out the stylus on her hand-held wireless computer, made a few taps and voila... I was up and running again. So that led me to ask, "How compliant are they with PCI Standards in this wireless environment?"
Now in two different scenarios, I've asked two questions. Both are the same question and focus on a single technology-wireless networks. The only difference is that I inserted a different standard. One primarily focuses on protecting Electronic Personal Health Information -- HIPAA, and the other primarily focuses on protecting credit card information -- PCI. The installation of a wireless network introduces a new set of issues that have to be addressed in order to be compliant with these standards.
What are some of these issues?
There is no physical medium by which your data is passed. With the data passing through the air, how do you contain access to it?
Traditional means to secure a wired network won't all work on a wireless network.
Attackers can attack a wireless network without having to go through an internet connection or firewall and remain anonymous.
So what are "some" security measures that could be put in place to address these issues and have a secure wireless network?
Make sure your data is encrypted if you handle sensitive information and/or that your wireless connection is encrypted. Even if someone is observing your signal, they won't be able to understand what they're viewing.
Make sure there is a method in place to authenticate each user as well as a method to authenticate the wireless network you're using. This is called mutual authentication.
Use a Virtual Private Network or a VPN whenever possible. If you have a wireless network connected to your wired network, you should be using a VPN.
Implement a Location-Based Wireless Security System. A Location-Based Wireless LAN security system gives you the ability to precisely determine the physical location of all wireless devices, in and around your RF environment. It continues to monitor your environment 24/7 and implements security protection mechanisms in real-time to address issues such as policy violations, rogue devices, vulnerabilities and threats.
Wireless networks are here to stay and should at least have the 4 security measure mentioned above in place. Wireless networks offer mobility, convenience and a relentless connection to the network, and it's something that every business (even those with a "No Wi-Fi Policy") is going to have to address, especially those that are subjected to standards like HIPAA, PCI, SOX, DOD Directive 8100.2 and GLBA, just to name a few.
Selasa, 05 September 2017
Enlisting Managed Hosting Services to Achieve Regulatory Compliance
Concerns over data security, particularly in the financial and medical services industries, have led to the development of new standards and regulations that govern how information is secured. As businesses move their data and applications to the cloud, managed hosting services can provide a cost-effective way to comply with heightened security requirements imposed by standards such as PCI DSS, HIPAA/HITECH and the Sarbanes-Oxley Act.
Companies that store, process or transmit cardholder data, for instance, are governed by the Payment Card Industry Data Security Standard (PCI DSS). This is a worldwide security standard created to help businesses that handle cardholder data to enhance security measures and protect customers from credit card fraud. In order to achieve compliance, businesses must be able to meet 12 stringent requirements and more than 200 security controls. Compliance is essential, however, since failure to follow the standard can result in heavy financial penalties.
Data security is also essential for the medical services industry. The Health Insurance Portability and Accountability Act (HIPAA) requires healthcare organizations to protect the privacy of individually identifiable health information. Organizations found in violation of HIPAA standards are liable for a maximum penalty of up to $1.5 million, as dictated by the Health Information Technology for Economic and Clinical Health (HITECH) Act.
Achieving compliance, however, can be challenging even for established businesses, since it's necessary to allocate a considerable amount of time and resources into building a secure, standards-compliant IT infrastructure. By utilizing the services of managed hosting providers with extensive experience in compliance management, companies can take advantage of the service providers' secure infrastructure and the expertise of personnel who are well-versed in the intricacies of industry/regulatory standards.
Preparing an organization's IT infrastructure for compliance requires a number of essential steps, which covers everything from installing anti-virus software and firewalls, to implementing strong access control measures and maintaining an information systems security policy. Regular log analysis, audits and host vulnerability scans are also implemented as part of a provider's compliance solution to spot potential security issues.
By entrusting mission-critical and sensitive client data to a managed hosting service provider, companies can rest assured that their database is housed in a secure network with enhanced security protocols and the constant care of IT professionals.
Considering the cost of running and maintaining a dedicated server, utilizing the services of a managed hosting service provider makes good business sense. By offloading server management and administration tasks to the experts, companies can focus on their core business competencies.
Companies that store, process or transmit cardholder data, for instance, are governed by the Payment Card Industry Data Security Standard (PCI DSS). This is a worldwide security standard created to help businesses that handle cardholder data to enhance security measures and protect customers from credit card fraud. In order to achieve compliance, businesses must be able to meet 12 stringent requirements and more than 200 security controls. Compliance is essential, however, since failure to follow the standard can result in heavy financial penalties.
Data security is also essential for the medical services industry. The Health Insurance Portability and Accountability Act (HIPAA) requires healthcare organizations to protect the privacy of individually identifiable health information. Organizations found in violation of HIPAA standards are liable for a maximum penalty of up to $1.5 million, as dictated by the Health Information Technology for Economic and Clinical Health (HITECH) Act.
Achieving compliance, however, can be challenging even for established businesses, since it's necessary to allocate a considerable amount of time and resources into building a secure, standards-compliant IT infrastructure. By utilizing the services of managed hosting providers with extensive experience in compliance management, companies can take advantage of the service providers' secure infrastructure and the expertise of personnel who are well-versed in the intricacies of industry/regulatory standards.
Preparing an organization's IT infrastructure for compliance requires a number of essential steps, which covers everything from installing anti-virus software and firewalls, to implementing strong access control measures and maintaining an information systems security policy. Regular log analysis, audits and host vulnerability scans are also implemented as part of a provider's compliance solution to spot potential security issues.
By entrusting mission-critical and sensitive client data to a managed hosting service provider, companies can rest assured that their database is housed in a secure network with enhanced security protocols and the constant care of IT professionals.
Considering the cost of running and maintaining a dedicated server, utilizing the services of a managed hosting service provider makes good business sense. By offloading server management and administration tasks to the experts, companies can focus on their core business competencies.
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