Representatives Seek OSHA Standard on Healthcare Workplace Violence

Lawmakers Seek OSHA Standard on Workplace Violence Prevention in Healthcare

Rep. Ro Khanna (D-CA) and 12 other House Democrats have introduced legislation intended to curb workplace violence in health care facilities.

The Health Care Workplace Violence Prevention Act, introduced March 8, would mandate that the federal Occupational Safety and Health Administration (OSHA) develop a national standard on workplace violence prevention that would require health care facilities to develop and implement facility and unit-specific workplace violence prevention plans.

According to the Bureau of Labor Statistics’ Census of Fatal Occupational Injuries, at least 58 hospital workers died as a result of workplace violence between 2011 and 2016. In 2016, the Government Accountability Office found that health care workers were five to 12 times more likely to encounter nonfatal workplace violence than all other workers.

The legislation follows regulation enacted in 2014 in California, which went into effect in 2017, directing Cal/OSHA to craft a workplace violence prevention standard. The law requires all covered health care employers in California to develop and issue – by April 1 – plans to prevent workplace violence and ensure the safety of patients and workers.

The bill introduced by Khanna is similar: Workplaces would create and implement comprehensive violence prevention plans with input from doctors, nurses and custodial workers. The bill stresses prevention, training and worker participation. It defines workplace violence broadly to include not only physical acts of violence, but threats of violence. It emphasizes staffing as a crucial ingredient in preventing violence from occurring and responding quickly when it does.

“Health care workers, doctors and nurses are continuously at risk of workplace violence incidents – strangling, punching, kicking and other physical attacks – that can cause severe injury or death,” Khanna said in a March 8 press release. “This is simply unacceptable. The Health Care Workplace Violence Prevention Act puts a comprehensive plan in place and is a national solution to this widespread problem modeled after the success seen in California.”  

See the Cal/OSHA regulation for details of the standard and what might be expected in the adoption of a National OSHA regulation.

National Nurses United (NNU), the nation’s largest union of registered nurses, applauded the bill.

“Right now, health care facilities are not doing enough to prevent these violent incidents,” NNU Co-President Deborah Burger said in a press release. “Under the proposed federal standard, facilities would need to assess and correct for environmental risk factors, patient specific risk factors, staffing and security system sufficiency.”

“There are a number of interventions that can reduce violence in healthcare. For example, affixing furniture and lighting so they can’t be used as weapons, maintaining clear lines of sight between workers while they are caring for patients, and providing easy access to panic buttons or phones to call for help,” Burger explained. “It is imperative that nurses, doctors, and other health care workers, along with security staff and custodial personnel, are all involved in the development and implementation of these plans.”

Sources: https://www.hcsiinc.com, https://www.dir.ca.gov, , http://www.safetyandhealthmagazine.com, https://www.securitymagazine.com, 
https://www.dir.ca.gov/dosh/workplace-violence-prevention-in-healthcare.html, https://oshareview.com

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100 in 10 Campaign

Healthcare Compliance Solutions, Inc. (HCSI)
has launched the “100 in 10” campaign.

What is the “100 in 10” Campaign?

The Healthcare Compliance Solutions Inc. “100 in 10” campaign was designed to encourage healthcare organizations to complete 100% of their new employees’ compliance training within their first 10 days.

100% Completion

First 10 Days

Why is it Necessary?

When a new employee is hired, outside of Medicare (within first 45 days), there is not a set time period for training the new hires on compliance regulations. With new hires, healthcare organizations will train their new employees on the different workings of the organization, the daily tasks the employee will perform, and other training's that are vital to the new employee’s ability to perform the job they have been hired to do. However, many organizations will postpone providing compliance training until it is convenient for them do conduct the training.

During this time, the employee continues to do his or her job while being ignorant on compliance regulations, office polices, and potential liabilities for the organization. All the while:

• They have been exposed to various forms of protected health information (PHI) without being trained on HIPAA regulations. 
• They have been moving around the office without knowledge of the safety protocols due to not being trained on OSHA regulations.
• They have been interacting with other co-workers before the new employee understands what is and what is not acceptable behavior within the organization because they have not been properly trained on HR Policies/Procedures.
• They do billing or other activities involving Medicare without being trained on Fraud, Waste, and Abuse.

All of this activity by the new employee is a major liability and puts the organization at unnecessary risk.

Recommendation

With more than 30 years of experience, it is the professional recommendation of HCSI that all new employees complete 100% of the compliance training within their first 10 days.

100% in 10 days is a goal that all healthcare professionals can achieve.

Make sure all of your new employees are 100 in 10!

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The Dragons of Healthcare Workplace Safety: HCS, SDS and GHS

Understanding The Hazardous Communication Standard, Safety Data Sheets (SDS), The Globally Harmonized System of Classification and Labeling of Chemicals (GHS) and how to properly implement them to insure workplace safety and comply with OSHA.

We at HCSI train healthcare professionals and their staff members on the Federal OSHA requirements for medical providers. Even though our training covers all required areas such and The Hazard Communication Standard, Safety Data Sheets, GHS labeling rules, etc., we occasionally get a frantic call from a confused practice manager or compliance officer after a friendly visit by an OSHA inspector.  Even though they were trained on these subjects, they invariably did not take the time to implement the training and translate it into the preparation of their site specific required safety and regulatory documentation. Once again, the classic saying, perhaps older then the dragons of ancient lore, rears it's ugly head... "If it wasn't documented, it never happened."

All hazardous chemicals found in the workplace/practice must be identified and a Master List must be compiled containing the names of products, their manufacturers and their chemical components. This Master List can be compiled from information gained from a list of OSHA regulated substances such as the NIOSH Pocket Guide to Chemical Hazards.

Safety Data Sheets (SDS) [previously called Material Safety Data Sheets (MSDS) which are now obsolete and superseded by the GHS Global Harmonized Standard implemented in 2013 replacing MSDSs with SDSs] are forms generally provided by chemical manufacturers that convey hazard-related information on chemicals and hazardous substances you use in your workplace.  It is important that employees know how to interpret the information found on each SDS, which describes the chemical composition, health and physical hazards and safe handling and emergency procedures for all products containing hazardous substances. 

In the U.S., the Occupational Safety and Health Administration (OSHA) requires that SDSs be readily available to all employees for potentially harmful substances handled in the workplace under the Hazard Communication regulation. The SDSs are also required to be made available to local fire departments and local and state emergency planning officials under Section 311 of the Emergency Planning and Community Right-to-Know Act. The American Chemical Society defines Chemical Abstracts Service Registry Numbers (CAS numbers) which provide a unique number for each chemical and are also used internationally in SDSs.

In 2012, the US adopted the 16 section Safety Data Sheet to replace Material Safety Data Sheets. This became effective on December 1, 2013. These new Safety Data Sheets comply with the Globally Harmonized System of Classification and Labeling of Chemicals (GHS). By June 1, 2015, employers were required to have their workplace labeling and hazard communication programs updated as necessary – including all MSDSs replaced with SDS-formatted documents.

Many companies offer the service of collecting, or writing and revising, data sheets to ensure they are up to date and available for their subscribers or users. Some jurisdictions impose an explicit duty of care that each SDS be regularly updated, usually every three to five years. However, when new information becomes available, the SDS must be revised without delay.

Hazard Communication Standard

The Hazard Communication Standard (HCS) is now aligned with the Globally Harmonized System of Classification and Labeling of Chemicals (GHS). This update to the Hazard Communication Standard (HCS) provides a common and coherent approach to classifying chemicals and communicating hazard information on labels and safety data sheets. This update will also help reduce trade barriers and result in productivity improvements for American businesses that regularly handle, store, and use hazardous chemicals while providing cost savings for American businesses that periodically update safety data sheets and labels for chemicals covered under the hazard communication standard.

In order to ensure chemical safety in the workplace, information about the identities and hazards of the chemicals must be available and understandable/(i.e. training provided) to workers. OSHA's Hazard Communication Standard (HCS) requires the development and dissemination of such information:

• Chemical manufacturers and importers are required to evaluate the hazards of the chemicals they produce or import, and prepare labels and safety data sheets to convey the hazard information to their downstream customers;
• All employers with hazardous chemicals in their workplaces must have labels and safety data sheets for their exposed workers, and train them to handle the chemicals appropriately. 

Major changes to the Hazard Communication Standard 

• Hazard classification: Provides specific criteria for classification of health and physical hazards, as well as classification of mixtures.
• Labels: Chemical manufacturers and importers will be required to provide a label that includes a harmonized signal word, pictogram, and hazard statement for each hazard class and category. Precautionary statements must also be provided.
• Safety Data Sheets: Will now have a specified 16-section format.
• Information and training: Employers are required to train workers on the new labels elements and safety data sheets format to facilitate recognition and understanding.

GHS Pictograms

As of June 1, 2015, the HCS requires that new SDSs to be in a uniform format, and include the section numbers, the headings, and associated information under the headings below:

Section 1, Identification includes product identifier; manufacturer or distributor name, address, phone number; emergency phone number; recommended use; restrictions on use.

Section 2, Hazard(s) identification includes all hazards regarding the chemical; required label elements.

Section 3, Composition/information on ingredients includes information on chemical ingredients; trade secret claims.

Section 4, First-aid measures includes important symptoms/effects, acute, delayed; required treatment.

Section 5, Fire-fighting measures lists suitable extinguishing techniques, equipment; chemical hazards from fire.

Section 6, Accidental release measures lists emergency procedures; protective equipment; proper methods of containment and cleanup.

Section 7, Handling and storage lists precautions for safe handling and storage, including incompatibilities.

Section 8, Exposure controls/personal protection lists OSHA’s Permissible Exposure Limits (PELs); ACGIH Threshold Limit Values (TLVs); and any other exposure limit used or recommended by the chemical manufacturer, importer, or employer preparing the SDS where available as well as appropriate engineering controls; personal protective equipment (PPE).

Section 9, Physical and chemical properties lists the chemical's characteristics.

Section 10, Stability and reactivity lists chemical stability and possibility of hazardous reactions.

Section 11, Toxicological information includes routes of exposure; related symptoms, acute and chronic effects; numerical measures of toxicity.

Section 12, Ecological information*

Section 13, Disposal considerations*

Section 14, Transport information*

Section 15, Regulatory information*

Section 16, Other information, includes the date of preparation or last revision.

*Note: Since other Agencies regulate this information, OSHA will not be enforcing Sections 12 through 15 (29 CFR 1910.1200(g)(2)).

Employers, please remember to periodically review and update your hazardous substance/chemicals Master List and ensure your SDSs reflect those changes and are readily accessible, readable and also understandable to your employees as well as any fire department personnel, inspectors and/or government officials. Annual OSHA training is also required to ensure your staff is educated, aware and updated on these and other vital workplace safety issues.

Protecting your employees, patients and your office's regulatory reputation is an ongoing process requiring diligence and oversight. You can not simply take an apprentice course in the basics of fending off dragons in the hopes of never encountering one of the dreaded beasts. The knighthood of compliance (OSHA or otherwise) requires the quest of discovering your office's site specific situations, knowing your procedures along with the discipline of documentation and the situational awareness to defend against the dragons of workplace safety and regulatory compliance. 

Source(s): https://www.hcsiinc.com, https://www.cdc.gov/niosh/npg/, https://www.osha.gov/dsg/hazcom, https://en.wikipedia.org/

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Protecting Doctors from Themselves

While practicing medicine, doctors must
protect their own integrity and reputation

It is a story that we were all shocked to hear about. USA Gymnastics Medical Professional and his inappropriate conduct with his patients and others. It is situations like this that make patients either grateful for or suspicious of the doctor they have.

Reality Time

When something so dramatic and public as the USA Gymnastics situation happens, it has numerous effects:

1. Patients who are victims of such horrific acts may develop the courage to speak out and tell their story.
2. Some people will begin looking for this type of situation in their life and find it, even if it does not exist.
3. There are people who are looking for the social media spotlight and begin making accusations in order to gain attention.

What Can a Doctor Do?

It is vital that a doctor take appropriate steps to protect him or herself from a possibly career ending situation:

• Continually communicate with the patient throughout their visit. They should know what the doctor is doing and why.
• Have written policies and procedures in place that focus on harassment and inappropriate conduct within the office. These policies should also include appropriate interactions with patients. This training should include ALL staff members including doctors and be done annually as well being thoroughly documented.
• Create a culture within the healthcare office of acting professionally and being current with all compliance laws.
• Communicate with patients that if at anytime they do not feel comfortable with the doctor or other staff members, that they are welcome to have an additional person of the same gender in the room during their visit.
• If the doctor does not feel comfortable being alone with the patient, then he or she should request and additional person (e.g. nurse or physician assistant) be present during the visit.

Possible Consequences

If a doctor is accused of some inappropriate behavior with a patient, then that doctor's reputation could be irrevocably damaged. It does not matter if the accusation has any truth to it, people will remember and the damage is done. It is best for the doctor to protect him or herself and avoid even the slightest hint of inappropriate behavior.

This type of situation cannot be taken lightly. Many doctors push away training, especially HR training, as inconvenient and a time waster. They do not understand that HR and other training's are in place for their protection. Documented HR and conduct training would play a key role in protecting a doctor and the reputation of the practice.

It is completely understandable that doctors want to focus only on practicing medicine, but they do not need to put themselves and their career at risk when doing so.

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Do You Know About TRACIE Sponsored by HHS?

Do You Know About TRACIE?

The U.S. Department of Health and Human Services (HHS) offers a comprehensive national knowledge center about emergency preparedness for health care, public health, and disaster clinical practitioners. The HHS Office of the Assistant Secretary for Preparedness and Response (ASPR) sponsors the ASPR Technical Resources, Assistance Center, and Information Exchange (TRACIE). The development and functionality of ASPR TRACIE are collaborative, involving multiple HHS Operating Divisions and other federal government departments/agencies; local, state, and regional government agencies; national associations; nonprofit organizations; and private sector partners. ASPR TRACIE is a healthcare emergency preparedness government information gateway that ensures that all stakeholders-at the federal, state, local, tribal, and territorial government levels; in nongovernmental organizations; and in the private sector-have access to information and resources to improve preparedness, response, recovery, and mitigation efforts. Each domain (TR, AC, and IE) provides users with unique support. ASPR TRACIE fills gaps in healthcare system preparedness capabilities by providing timely, innovative ways to share information and promising practices during planning efforts. In the dynamic environment of a disaster, ASPR TRACIE will leverage resources to better integrate support and will serve as a force multiplier by improving information sharing and minimizing duplication of effort. For More Information: Click Here for the Healthcare Emergency Preparedness Information Gateway Fact Sheet Click Here to go to the ASPR TRACIE website

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Preventing Harassment Depends On Your Organizational Culture

Individual behaviors do not present as much of a risk factor for harassment as does the organizations' culture

Sarah was surprised when Mike came into her office to file a harassment complaint. Everyone within the organization had just completed Harassment Training the previous week, but yet here is Mike sitting in Sarah's office. Mike is complaining that he is being bullied in the office by multiple staff members. Sarah is very aware that this is covered within the organizations Harassment Training, so why was it happening? This situation has the potential of getting messy and dragging on for quite sometime.

Harassment is a decision made by an individual when his or her 

work environment allows for it.

Yes, the above statement is a hard fact to face. When an individual decides to take action in an inappropriate manner, that decision was made using various factors:

• What is the character of the individual in question?
• Does he or she have a history of inappropriate actions or words, but not held accountable for those actions or words?
• Did the individuals' supervisor report any suspicious activity, words, or mannerisms?
• Is there motivation behind the individuals actions or words?

All of the above questions do not necessarily point to the individual, but rather the organization and the culture that lives within that organization. Harassment thrives in organizations that lack respect, a healthy culture, and accountability.

Victoria Lipnic of the Equal Employment Opportunity Commission (EEOC) stated the following:

"Too much of the effort and training to prevent workplace harassment over the last 30 years has been ineffective an focused on simply avoiding legal liability. In simplest terms, training must change. That does not mean we are suggesting that training be thrown out - far from it - but training needs to be part of a holistic, committed effort to combat harassment, focused on the specific culture and needs of a particular workplace. Above all, employees must have faith in the system." (1)

Simply having a reactive system in place that responds to harassment claims is not enough. Out of fear of retribution, employees may not report the harassment when it occurs. It is becoming vital for organizations to lessen the opportunity for harassment from happening so significantly, that it is nearly non-existent within the organization. This type of harassment free environment is created from the culture that exist within the organization. Here are some suggestions to help create a harassment free culture:

• Hire not just for skills and knowledge. The character of the individual must be a top priority when considering who to bring into the organization.
• When an individual does act inappropriately, they must be held accountable. A slap on the wrist or a simple "tongue lashing" will not deter the individual or others from inappropriate actions in the future.
• Effective supervisor training is a critical component. Supervisors must receive proper training that enables them to identify strange behaviors, words spoken, or mannerisms. When something odd occurs, it should be documented and monitored.
• Create an environment of positive thinking, mutual respect, and support for fellow co-workers.
• Ensure that your harassment policies are equal for everyone within your organization. One classification of worker should not have an advantage over another or receive special treatment.
• Be sure everyone within the organization (at all levels) receives harassment training and this training is acknowledged through documentation. As part of your harassment training, ensure that all members of the organization understand what is considered harassment.
• False harassment accusations should not be tolerated. A growing number of employees have been falsely accusing their co-worker of harassment in order to gain a competitive advantage over that co-worker.

Creating a "harassment free" culture within your organization will never completely eliminate harassment from occurring. However, it will greatly reduce the opportunity for it to occur.

Don't put your organization at risk by having a reactive approach to harassment. Take measures to be more proactive in your approach. Your employees will be grateful for the safer work environment that will be created and it will reduce the liability risk to the organization.

Individuals will be who they are. Try to ensure that you have the best people within your organization who, through their character, actions, and words are representatives of an organizational culture that you can be proud of!

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Importance of Written Time Off Policies

Managing time off requests effectively
will help reduce your liability

There are certain times of the year, summer and holidays, when a significant number of employees request time off from work. While it would be nice to accommodate all of the time off requests, work still needs to get done. In addition to reduced productivity, there is another factor with time off requests that increases liability, reduces morale, and sours the great culture that has been building within the organization. All of these are the result of unfair time off practices.

Reduce Liability

All of your time off requests should be done by following a written policy and procedure. Time off policies should be the same for the same type of employee (part-time or full-time). Be sure that the written time off policies are in no way discriminatory of gender, race, religion, or other factor.

Keep Morale High

If the written policies and procedures are not deviated from and are followed, then there should be no appearance of favoritism. It is the appearance or perception of favoritism that has a destructive influence on the morale of other employees.

Culture is Still Great

Any type of special allowances of time off could have a souring effect on the culture of an organization. Remember, everyone would like to have a special day off and get paid for it. If it is not written in the policies and procedures, don't do it. If someone really needs to have a day off and it is outside of the written policies, then the day off can be granted to the employee, but it would not be an unpaid day off. This would not have the same souring effect on the culture as a paid day off would have.

Reduce liability, keep the morale high, and maintain a great culture by having fair and written time off policies and procedures that are strictly followed.

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OSHA's New Fact Sheet on Preventing Zika Virus Exposure in Healthcare Workers

OSHA has released a new fact sheet on preventing Zika virus exposure in biomedical laboratory and other healthcare workers.

The Zika virus was found in the Americas and the Caribbean in 2015. Symptoms include fever, rash and joint pain. The virus, which can spread from a pregnant woman to her fetus, has been linked to a serious birth defect of the brain known as microcephaly.

Zika virus is primarily spread through the bites of infected mosquitoes. There is no vaccine to prevent Zika virus infection, and there is no specific treatment for people who become infected. Although Zika virus is primarily spread by infected mosquitoes, exposure to an infected person’s blood or other body fluids may also result in transmission. 

Outdoor workers may be at the greatest risk of exposure to Zika virus.  Some workers, including those working with insecticides in areas of active Zika transmission to control mosquitoes and healthcare workers who may be exposed to contaminated blood or other potentially infectious materials (OPIM) from people infected with Zika virus, may require additional protection. 

Although, to date, there are no absolutely confirmed reports of transmission of Zika virus from infected patients to health care personnel or other patients in the United Sates; minimizing exposure to body fluids is important to reduce the possibility of such transmission. The CDC has previously recommended Standard Precautions in all health care settings to protect both health care personnel and patients from infection with Zika virus as well as from blood-borne pathogens (e.g., human immunodeficiency virus [HIV] and hepatitis C virus [HCV]).

The New OSHA fact sheet on the Zika virus details how laboratory exposures occur, often through bodily fluids, and how to prevent exposures. Labs should undergo risk assessments, OSHA advises, with the fact sheet detailing the standards, recommendations and biosafety practices to follow.

OSHA also looks at worker training required under its (BBP) Bloodborne Pathogens Standard (1910.1030), and what employers should do in the case of an exposure or if a worker shows signs/symptoms of the virus.

Guidance to Healthcare and Laboratory Workers

• Employers and workers in healthcare settings and laboratories should follow standard infection control and biosafety practices (including universal precautions) as appropriate, to prevent or minimize the risk of Zika virus transmission.
• Standard precautions include, but are not limited to, hand hygiene and the use of (PPE) Personal Protective Equipment to avoid direct contact with blood and other potentially infectious materials, including laboratory specimens/samples. PPE may include gloves, gowns, masks, and eye protection.
• Hand hygiene consists of washing with soap and water or using alcohol-based hand rubs containing at least 60 percent alcohol. Soap and water are best for hands that are visibly soiled. Perform hand hygiene before and after any contact with a patient, after any contact with potentially infectious material, and before putting on and upon removing PPE, including gloves.
• Laboratories should ensure that their facilities and practices meet the appropriate (BSL) Biosafety Level for the type of work being conducted (including the specific biologic agents – in this case, Zika virus) in the laboratory.
• Employers should ensure that workers: Follow workplace standard operating procedures (e.g., workplace exposure control plans) and use the engineering controls and work practices available in the workplace to prevent exposure to blood or other potentially infectious materials.
• Employers should ensure workers do NOT bend, recap, or remove contaminated needles or other contaminated sharps. Properly dispose of these items in closable, puncture-resistant, leak-proof, and labeled or color-coded containers. Workers should use sharps with engineered sharps injury protection (SESIP) to avoid sharps-related injuries.

The fact sheet notes that the Zika virus is “a nationally notifiable condition” and labs should consult the Centers for Disease Control and Prevention for reporting guidelines.

If an employee becomes infected, the CDC recommends that infected individuals rest, drink fluids, and take acetaminophen for fever and pain reduction. Infected persons should avoid further mosquito bites by covering skin and using an insect repellent containing DEET.

Employers should ensure that workers receive prompt and appropriate medical care for suspected Zika infection. If the exposure falls under OSHA’s BBP standard, employers must comply with OSHA medical evaluation and follow-up requirements. Also employers should consider options for granting sick leave during the active period of infection.

Sources: www.hcsiinc.com, www.osha.gov, www.cdc.gov, www.safetyandhealthmagazine.com 

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Discussing Pay at the Office

Many employers restrict their employees from conversations about pay at the office, but is this legal?

It is a common practice in many companies for the employee policy manual to contain some verbiage about not discussing compensation and pay with other employees. This policy is easily agreed to by the employees and thus the company has achieved its goal of keeping the often times illegal practice of pay secrecy in place.

Is Pay Secrecy Illegal?
In 1935, Congress passed a law entitled, the National Labor Relations Act or the “Wagner Act”. Under this act, private-sector employees have the right to engage in “concerted activities for the purpose of collective bargaining or other mutual aid or protection.” For this reason, restricting private-sector employees from discussing their compensation with one another is illegal. There is a limit as to who can discuss pay with other employees. Supervisors, for example, would not be considered an “employee” and therefore they can be prohibited from discussing pay. In addition, employees who have access to a company’s payroll could also be prohibited from sharing other employee’s private salary information.


Why is the Wagner Act in Place?

It was the purpose of the Wagner Act to protect employees against unfair pay practices. Giving the employees the freedom to discuss their compensation does a lot to help avoid unfair pay practices and puts pressure on a company to ensure pay-for-value (pay based on experience, education, skills, and the assigned responsibilities of the job) is in place. If an organization has a pay-for-value system in place, then they would not be afraid of employees discussing their compensation with each other. It is when a company has something to hide within their pay practices that problems arise when pay is discussed.

Employers Who Violate This Law

Employers who violate this law could have repercussions that would range anywhere from a wrongfully terminated lawsuit to the possible loss of federal contracts.

If an employee has been wrongfully fired for discussing their pay, they are may contact the National Labor Relations Board (NLRB) and file a complaint. The NLRB may begin an investigation into the matter regarding their former employer.

In most cases, pay secrecy is against the law. Employer should have a pay-for-value system in place and avoid any possible penalties for violating the Wagner Act.

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Where Is Your PHI Data Traveling Today?

Understanding "The Cloud" and it's regulatory relationship with HIPAA and PHI.

With most vendors offering and pushing cloud computing solutions and offsite data backup, or guaranteeing offsite backup of data they process for you, many HIPAA covered entities (CEs) and business associates (BAs) are questioning whether and how they can take advantage of cloud computing while complying with regulations protecting the privacy and security of electronic protected health information (ePHI). 

What "Cloud" computing means is that instead of all the computer hardware and software you're using sitting on your desktop, or somewhere inside your company's network, it's provided for you as a service by another company and accessed over the Internet, usually in a completely seamless way. Exactly where the hardware and software is located and how it all works doesn't matter to you, the user -- it's just somewhere up in the nebulous "cloud" that the Internet represents. 

The business decision to "move to the cloud" is often financially motivated. Companies used to have to buy their own hardware equipment, the value of which depreciated over time. But now with the cloud, companies only have to pay for what they use. This model makes it easy to quickly scale use up or down and to have data backed up for you as part of that provided service.

The rise of offshore IT services, including distributed storage, by cloud data providers creates issues that most healthcare providers have not yet realized. Even if some of the issues are realized, many covered entities and their business associates do not know where their data is currently being processed, stored, or backed up. In fact, storage or processing of protected health information (PHI) overseas may or may not be permitted or at least require additional resources, such as additional or more detailed risk assessments.

There are currently no federal regulations or statutes that prevent storing or processing PHI offshore or overseas; however, the Centers for Medicare and Medicaid Services (CMS), the U.S. Department of Health and Human Services (HHS), and the U.S. Office of Civil Rights (OCR) within the HHS, have all issued regulations or provided guidance that restrict storing or processing PHI offshore. In addition, there are four states that ban any Medicaid data from being stored or processed overseas (Arizona, Alaska, Ohio and Wisconsin), two more that only allow offshore contracts under extremely limited circumstances, and nine more that have specific requirements that must be met before any offshore processing or storage of Medicaid data is allowed. 

Even if a healthcare provider is not located in one of the above states, if the provider has treated a patient of those states, state regulators may argue that the healthcare provider must comply with their laws, regulations, and guidance, as applied to the resident of their state. Even more concerning is that even though Delaware does not have any laws or statutes banning offshore processing or data storage, Delaware recently started adding provisions to all of their contracts (similar to Wisconsin) that the State (Delaware) will not permit project work to be done offshore. There may be additional states adding these prohibitions to their contracts in the future.

If extra regulatory burden and potential state law bans were not enough by themselves, any PHI stored offshore likely will be subject to local law of the country in which it is stored. Furthermore, these local laws may allow for actions or even access to the data that directly conflicts with requirements on healthcare providers under HIPAA/HITECH, even if the vendor signed a Business Associate Agreement (BAA). Due to the issues in enforcing HIPAA and HITECH, and even a BAA against an overseas vendor, HHS has basically stated that it is the duty of the healthcare provider or vendor for deciding how to vet data services vendors and comply with expected additional requirements when conducting a risk assessment on overseas providers. 

At this point, most healthcare providers question if any offshore or offsite data storage or processing is worth any potential cost savings, or if OCR has any further guidance. In the fall of 2016, OCR prepared guidance that explained how federal health information privacy and data security rules apply to cloud services. In summary, this guidance helped data service companies, but at the expense of covered entities by primarily placing the burden on the covered entities, specifically hospitals, insurers, doctors, and other healthcare providers.

In looking at data service vendors, OCR decided that data service subcontractors of the covered entities’ business associates are actually business associations of the business associates. According to the OCR, covered entities must assess the cloud services providers’ or offshore providers’ data security efforts, but HIPAA does not require the cloud services providers to allow covered entities audit them. As such, covered entities are required to determine how well a cloud services provider handles system reliability, data security, and data backup and recovery, without the ability to perform an audit. While this is problematic when dealing with domestic cloud service providers, it creates additional issues when dealing with overseas cloud service providers. 

While OCR allows use of overseas providers, as of right now the rules of HIPAA and HITECH fail to address any international aspects, leaving no requirements but also no protections for covered entities. If you select a domestic provider, the laws and regulations regarding PHI apply to both parties, but if an overseas provider is selected, HIPAA and HITECH will not apply, unless they contractually agreed to comply with such laws and regulations. If there is a breach and the overseas provider refuses to defend against or pay any fines or fees levied related to the breach, the covered entity may be liable for paying. It is also important to note that while an international provider may agree to sign a BAA, many international providers do not understand the requirements of HIPAA and HITECH, while most domestic providers have a greater understanding.

Even if you know where the company with whom you are contracting is located, do you know where they send the backup data? Do they send data for processing or backup to other agents, subcontractors, vendors, or other data providers overseas? You may not realize your data is regularly taking international trips, and may be better traveled than you are. In addition, if a relationship is terminated with an international provider, how will you ensure that the data is wiped from the system? Healthcare providers generally must require a certificate of destruction when terminating data services, and will you be able to comply with this provision with an offshore provider?

In contracting with cloud service providers, including backup providers, e-mail providers, and other processing entities, covered entities and their business associates must determine where their data is located, and if it is offshore, they must analyze if any of the information is prohibited from being exported by any state or local regulations. If not, next it must be determined if there is an extra compliance burden associated with the data being offshore, and if that extra compliance burden and the associated risk of being offshore are worth any cost savings by using the offshore provider. If an entity knows that some of its data may be banned from being exported overseas, or would raise too much risk or compliance burden, then language banning such exports should be placed in the agreements, including any BAAs. 

Used with permission from: Craig A. Phillips council member of Dickinson Wright

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