House committee takes interest in ‘NotPetya’ malware attack fallout

House Energy and Commerce Committee leaders are concerned that a malware attack from late June 2017, known as “Petya” or “NotPetya,” may have lingering effects on Merck & Co, Inc. The leaders sent letters to Merck’s CEO and HHS Secretary Price expressing this concern and requesting additional information about the attack and the effects on the company.

NotPetya

The malware infection began on June 27, 2017, and spread across the world, infecting businesses from a variety of sectors. At the time of the attack, the extent of Merck’s vulnerability was not precisely known, although an employee reported that they were told to stop working and some computers appeared to be wiped and that all U.S. offices were affected by the attack. The committee letters referred to information provided in Merck’s second-quarter 2017 financial outlook, which stated that packing operations were mostly restored, formulation operations were partially restored, and active pharmaceutical ingredient operations were partially restored but bulk product was not yet being produced.

Patient risk

The committee’s interest in the matter stemmed from concern that patients may have been negatively impacted by manufacturing disruption. Although evidence of such risk was not present, the committee pointed to an announcement from the Centers for Disease Control and Prevention (CDC) that certain formulations of Merck’s Hepatitis B vaccine would not be available. The committee requested that Merck provide a formal briefing to the committee on the initial infection and Merck’s steps to recover and resume manufacturing by October 4, 2017. The committee also requested an HHS briefing on the agency’s steps to understand and respond to the situation as well as plans for addressing drug shortages or other consequences stemming from cyberattacks.

Kusserow on Compliance: FBI on cybersecurity—advice and tips

The FBI recently made presentations on cyber security at the Boston Conference on Cyber Security and at the American Hospital Association annual meeting. Key points from these presentations included, underscoring that the FBI is the lead federal agency for investigating cyber-attacks by criminals, overseas adversaries, and terrorists. The FBI views cyber threats seriously, as a growing problem as cyber intrusions are becoming more commonplace, more dangerous, and more sophisticated. Both private and public sector networks are targeted by adversaries for trade secrets, sensitive business data, and privacy information. Universities are targeted for their research and development. Individuals are targeted by fraudsters and identity thieves. Children are targeted by online predators. The FBI has been gearing up to the challenges from these threats by enhancing its Cyber Division’s investigative capacity to sharpen its focus on intrusions into government and private computer networks. However, they are struggling against a number of challenges, including finding talented workers in competition with the private sector, and the fact that a majority of cyber-attacks are never reported because parties want to address the problem without getting entangled in an FBI investigation. This hampers their work. The FBI desires to encourage better reporting, emphasizing that the agency has an interest in protecting private information and data; any internal information received will not be used against a provider, as they will be treated as a victim. The FBI recognizes that health care organizations are major targets for cyber-criminals, because the sensitive data they collect in droves can be sold at a high price for use in fraud and identity theft. Medical devices are also increasingly becoming a target.

The FBI is encouraging health care companies to share some basic network information with their local FBI offices, before an attack occurs, and to join an information-sharing group with other companies in their industry. The following observations and advice came from the two FBI presentations:

FBI Advice and Tips

  1. People are “weak links” in cyber-attacks, so train them to recognize and prevent cybercrimes.
  2. Review if everyone with high-level access to a hospital’s database needs to have that access.
  3. It is important to update and patch systems regularly to prevent intrusion.
  4. More people with security access, the easier it is to breach.
  5. Conduct regular systems tests to help flag vulnerabilities before a hacker can gain access.
  6. Develop a business continuity plan to prevent down time.
  7. Establish real-time data backups to permit work to continue.
  8. Organizations should establish closer ties with the local FBI before there is any incident.
  9. Those harmed in a cyber-attack will be treated like victims of a crime.
  10. Called for building a relationship with the local FBI.
  11. Organizations should join information-sharing groups with others in their industry.
  12. Regular systems tests can also help flag vulnerabilities before a hacker can get in.
  13. Don’t assign responsibility for cyber security to someone at a low level in the organization.
  14. Cyber security is an enterprise risk and executive and board level interest is needed.

Richard P. Kusserow served as DHHS Inspector General for 11 years. He currently is CEO of Strategic Management Services, LLC (SM), a firm that has assisted more than 3,000 organizations and entities with compliance related matters. The SM sister company, CRC, provides a wide range of compliance tools including sanction-screening.

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Copyright © 2017 Strategic Management Services, LLC. Published with permission.

AMA preparing to tackle questions surrounding physician-patient texting

Regulators are serious about privacy and violations of the Health Insurance Portability and Accountability Act (HIPAA) (P.L. 104-191), and crackdowns keep providers on their toes. The evolution of technology provides innovative and efficient ways to practice medicine and communicate with patients, but this evolution brings with it new obstacles that can easily trip up a provider who is not paying close attention. At the end of a long day, a tired doctor might send a quick text to a mother who does not want to bring in her sick child if over-the-counter medicines will do the trick, trying to be as accommodating as possible and truly caring for the patient’s well-being. Both mother and doctor will be relieved that an unnecessary trip was avoided, but is this type of communication appropriate?

The American Medical Association (AMA) provides guidelines for providers on issues just like this one, and the AMA House of Delegates will consider expanding its advice on email communications to include text messaging at a June meeting. Although the AMA maintains that a face-to-face meeting is the foundation of a physician’s relationship with a patient, it recognizes that patients and physicians may prefer text message communications in various settings.

Considerations when texting

As expected, the AMA’s first basic standard of engagement to consider is HIPAA. The Board of Trustees (BOT) recommends discussing obligations under HIPAA’s Security Rule with both information technology (IT) staff and legal counsel. This rule requires that entities transmitting electronic protected health information (ePHI) ensure that these transmissions are confidential and secure. The AMA provides an educational tool to assist providers in achieving compliance with the rule, and HHS offers advice on protecting ePHI when using cell phones.

Providers should keep in mind potential differences in communication with patients, as opposed to colleagues. While doctors and nurses in the same office may think nothing of texting one another, a patient needs to consent to communication. Current guidance indicates that a patient’s initiation of a text conversation may serve as consent, but some providers might obtain written consent that acknowledges risks in such transmissions. Patients should be reminded that security is not guaranteed and that privacy can be breached as easily as someone they know using their phone and seeing a text.

Boundaries

In addition to consent and security issues, the AMA raises several points more along the lines of etiquette but that must be approached within the patient-physician relationship framework. A physician should establish boundaries with patients, such as establishing reasonable response times and appropriate times of day for texting. Additionally, extensive conversations are not recommended, and if a patient requests a lengthy explanation the physician should request that the patient come into the office.

When texting, the AMA recommends keeping a formal tone, cordial but refraining from using jokes, emoticons, or emotionally charged or sarcastic speech. The recommendations even extend to ending texts with the physician’s full name and business affiliation, accompanied by a request to acknowledge receipt of the message. Although it may seem obvious, the AMA also reiterates refraining using identifying information such as name or Social Security number and keeping text records.

Gatekeeping vital to a best practice organization

Gatekeeping should be viewed as a first line of defense, protecting not only a healthcare organization, but the patients as well. In a Health Care Compliance Association (HCCA) webinar titled “Gatekeeping & Monitoring – Developing Sound Processes for Screening, Removal & Reinstatement,” Amy Andersen, Director of Operations at Verisys Corp., noted that every organization can be sorted to a risk aversion spectrum. On one end, the most risk-averse organizations use best practice compliance to achieve stellar outcomes. On the other end, non-compliant organizations risk fines and loss of reputations. The greatest cost to organizations in terms of monetary impact to establish gatekeeping measures is the change management and system implementation. Regardless, best practices organizations need to be proactive about gatekeeping and monitoring, not after the fact.

Gatekeepers

The best way to protect organizations is to implement a gatekeeping strategy. Gatekeeping is ensuring that information is properly disseminated among an organization and its association. Thus, the first consideration for an organization is which parties are being let into the organization. Organizations should not only focus on the healthcare professionals within their organizations, but the vendors and contractors employed by the organization. Andersen noted that the vendor space was one of the most overlooked areas in protecting an organization.

Secondly, once an organization permits vendors or individuals into the organization, it must readily identify any gaps. In essence, Andersen said that the organization should understand what it knows and does not know about the admitted vendor or individual.

Finally, the organization should establish criteria for admittance of these vendors or individuals. Thus, an organization’s gatekeeping strategy should include three parts: (1) identification, (2) communication, and (3) remediation.

Identification, communication, and remediation

At a most basic level, identification starts with screening and monitoring. Some barriers to gatekeeping include data “hoarders,” those entities who do not share what they know or require you to go through a gate itself. These entities can be threats to the organization.

Andersen advised that organizations should examine and avoid unconsidered risks. In terms of credentialing, Andersen stressed “verify, verify, verify.” These risks are created when an organization silos information within itself. She cautioned against this, noting that organizations should do holistic reviews to determine whether the departments within the organization are communicating any risks effectively.

Access to information is vital. Once identification generates data for the organization, relevant information must be made visible. After policy and procedure access occurs, the organization must take action in a consistent manner. This is includes removal of individuals from the organization or vendor from a business relationship, expectations should be laid out clearly. Any auditing that is done should be unbiased and adhere to industry standards.