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Cyber-Security Considerations for “Mission-Critical” Medical Devices

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Understanding the balance between new regulations (almost none) and guidance (in the form of non-binding recommendations)

By Shahid N. Shah MS

Shahid N. ShahTHEN …

In 2013, the Food and Drug Administration (FDA) issued its first cybersecurity safety communication, followed in 2014 by final guidance.

It struck a reasonable balance between new regulations (almost none) and guidance (in the form of non-binding recommendations).

NOW …

In 2015, the Federal Trade Commission (FTC) released a staff report entitled Internet of Things: Privacy & Security in a Connected World, in which it recommend that Internet of Things (IoT) style devices, which of course include medical and clinical devices, need to maintain a good security posture. It’s worth noting that the FDA, FTC, and other government regulators are centering on a few key guidelines.

Six Recommendations

The following six recommendations come directly from the FTC report:

  1. Companies should build security into their devices at the outset, rather than as an afterthought. As part of the security by design process, companies should consider:
  • Conducting a privacy or security risk assessment
  • Minimizing the data they collect and retain
  • Testing their security measures before launching their products
  1. Companies should train all employees about good security, and ensure that security issues are addressed at the appropriate level of responsibility within the organization
  2. Companies should retain service providers that are capable of maintaining reasonable security and provide reasonable oversight for these service providers.
  3. When companies identify significant risks within their systems, they should implement a defense-in-depth approach, in which they consider implementing security measures at several levels.
  4. Companies should consider implementing reasonable access control measures to limit the ability of an unauthorized person to access a consumer’s device, data, or even the consumer’s network.
  5. Companies should continue to monitor products throughout the life cycle and, to the extent feasible, patch known vulnerabilities

The FTC report and FDA guidelines are remarkably consistent. When thinking of cybersecurity and data privacy, engineers tend to think about authentication, authorization, and encryption. Those are the relatively easy topics.

*** circuit***

Mission Critical Medical Devices

For “mission-critical” medical safety devices, however, things are much more difficult and need to encompass a larger surface of questions, including but not limited to:

  • Asset Inventory: Is the device discoverable, and can it associate itself with standard IT inventory systems so that revision management, software updates, and monitoring can be automated?
  • Cyber Insurance: Does the device have enough security documentation to allow it to be insured by standard cyber insurance riders?
  • Patching: How is the firmware, operating system (OS), or application going to be patched by IT staff within hospitals (or the home for remote devices)?
  • Internal Threats: Has the device been designed to circumvent insider (hospital staff, network participants, etc.) threats?
  • External Threats: Has the device been designed to lock down the device from external threats?
  • Embedded OS Security: Is the device sufficiently hardened at the operating system level, such that no extraneous software components, which increase the attack surface, are present?
  • Firmware and Hardware Security: Are the firmware and hardware components sourced from reputable suppliers and free of state-sponsored spying?
  • Application Security: Is the Microsoft Security Development Lifecycle (SDL) or similar software security assurance process integrated into the engineering process?
  • Network Security: Have all network protocols not in use by the device been turned off so that they are not broadcasting?
  • Data Privacy: What data segmentation, logging, and auditing is being done to ensure appropriate data privacy?
  • HIPAA Compliance: Have proper steps been followed to ensure Health Insurance Portability and Accountability Act (HIPAA) compliance?
  • FISMA Compliance: If you’re selling to the federal government, have proper steps, such as use of Federal Information Processing Standard (FIPS) certified encryption, been followed to ensure Federal Information Security Management Act (FISMA) compliance?
  • Data Loss Prevention (DLP): Is there monitoring in place to ensure data leakage outside of the device doesn’t occur?
  • Vulnerabilities: Have common vulnerabilities such as the Open Web Application Security Project (OWASP) Top 10 been reviewed?
  • Data Sharing: Are proper data sharing agreements in place to allow sharing of data across devices and networks?
  • Password Management: Are passwords hardcoded into the device or made configurable?
  • Configuration Protection: Are configuration files properly check-summed and protected against malicious changes?

Conclusion

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ABOUT

Mr. Shahid N. Shah is an internationally recognized healthcare thought-leader across the Internet. He is a consultant to various federal agencies on technology matters and winner of Federal Computer Week’s coveted “Fed 100″ Award, in 2009. Over a twenty year career, he built multiple clinical solutions and helped design-deploy an electronic health record solution for the American Red Cross and two web-based eMRs used by hundreds of physicians with many large groupware and collaboration sites. As ex-CTO for a billion dollar division of CardinalHealth, he helped design advanced clinical interfaces for medical devices and hospitals. Mr. Shah is senior technology strategy advisor to NIH’s SBIR/STTR program helping small businesses commercialize healthcare applications. He runs four successful blogs: At http://shahid.shah.org he writes about architecture issues; at http://www.healthcareguy.com he provides valuable insights on applying technology in health care; at http://www.federalarchitect.com he advises senior federal technologists; and at http://www.hitsphere.com he gives a glimpse of HIT as an aggregator. Mr. Shah is a Microsoft MVP (Solutions Architect) Award Winner for 2007, and a Microsoft MVP (Solutions Architect) Award Winner for 2006. He also served as a HIMSS Enterprise IT Committee Member. Mr. Shah received a BS in computer science from the Pennsylvania State University and MS in Technology Management from the University of Maryland. 

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Understanding Medical Practice Anti-Trust Risks

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Medical Risk Management

By Dr. Charles F. Fenton III JD

fenton* Monopolistic risks are reduced when more than a few networks or contracts are available in the local area for excluded medical providers to join.

  • * Fee schedule MCO contracts, per se, are not generally considered price fixing, provided the doctor providers have not conspired with one another to set those prices. Moreover, network pricing schedule should not spill over into the non-network patients.

Some Issues:

  • Individual providers may be excluded from a network if there is a rational reason to do so. It is much more difficult to exclude a class of providers, than it is to exclude an individual provider.
  • A safety zone can be created if networks or other contractual plans require a substantial amount of financial risk-sharing among plan participants, since Stark II laws have been relaxed. Such zones have been created by the Department of Justice (DOJ) and Federal Trade Commission (FTC), in recent policy statements.
  • The FTC and DOJ are not likely to challenge an exclusive provider IPA that includes no more than 20-25% of the doctors within the panel, who share financial risk. Such panels are likely to fall within a Safe Harbor.
  • Tying arrangements (e.g.: the requirement to buy one item/service in order to buy another item/service) are suspect if not reasonably justified. For example, a patient should not be required to obtain a brace prescription from a specific provider, in order to purchase the device from a laboratory that the doctor owns.
  • Non-exclusive provider panels will not usually be challenged if no more than 30% of the providers are included (another Safe Harbor provision). Physician networks are often analyzed according to four criteria: (1) anti-competitive effects, (2) relevant local markets, (3) pro-competitive effects, and (4) collateral agreements.Further anti-trust considerations consist of analyzing
  • Market Power. This consists of two factors: (1) Geographic Power and (2) Product Power.

###

Flag MOney

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  • Geographic Power is difficult to define in today’s environment. In the past, the geography that was analyzed when medical practices merged was the immediate neighborhood. Currently, the geographical area could consist of an entire metropolitan area. In the past, individual patients would often seek a physician whose office was close to work or home. Now they seek a physician based on inclusion in a health plan. Now, health plans choose physicians based on needs within an entire metropolitan area.
  • Product Power relates to the specific service being performed. There are two products in today’s environment: (1) Primary Care and (2) Specialty Care. Since there are so many primary care physicians in practice, it would be difficult for all but the largest group to acquire product power.

Assessment

It is easier for medical specialists to develop product power. However, certain specialists may never be able to obtain product power.

For example, foot care is provider by many types of physicians. Primary care physicians, emergency physicians, chiropractors, physical therapists, orthopedic surgeons, nurse practitioners, and podiatrists all provide foot care. Therefore, it would be difficult, even for a large group of podiatrists to obtain significant product power.

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How I Lost my Battle Against the NPI

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Refusing a National Provider Identifier Number

By Darrell K. Pruitt DDS

pruittI can no longer refuse to apply for a National Provider Identifier (NPI). I lost that long battle. Anyone rejoicing?

I’m spent. My leverage has vanished. Telling insurers “I have no NPI” held much more inherent power than “I have an NPI but I won’t share it with you on principle.” Far too many words. My profession has become dominated by unresponsive, unaccountable 3rd parties that dental leaders in the ADA welcome as policy. Working together, they promote and commandeer the technology dentists purchase and clueless patients pay for in increased fees. I have painfully learned that principles are only for dentists who can still afford them, and it’s a bad economy for luxuries.

Non-HIPAA Entity

Since I am not a HIPAA-covered entity and therefore not required by law to adopt an NPI, my capitulation to extortion disappoints me as an American citizen. I still find it hard to believe that an anti-consumer HIPAA rule enthusiastically enforced by the dental benefits industry could force me to “volunteer” for a PERMANENT identifier. As I and 96% of dentists become jerked around by our NPIs, I hope dental historians note that I am the ONLY dentist who publicly asked “Why?” instead of “Why not?” After 6 years, I’m still awaiting an answer to that question from leaders who continue to promote the NPI to dentists while ignoring their questions.

Dental Benefits Providers

I was able to hold out up until Aetna, Delta Dental and other dental benefits providers deprived my office of access to details of patients’ dental benefits unless I have an NPI. I’m waiting for someone – anyone – to tell me how the identifier can possibly improve the dental care of those who pay Aetna and Delta Dental premiums, especially if their benefits are intentionally kept secret from their dentists. I am certain that if the nation’s employers who purchase dental benefits were aware of the transparent nonsense, they would never purchase such products. Where’s the US Chamber of Commerce? Where’s the FTC? How about the US Constitution?

This is exactly why there needs to be more openness in our profession, Doc. The cockroaches who were invited to quietly overrun dentistry cannot withstand transparency, yet I don’t know how much longer I can fight for it without further risking the health of my practice.

As anyone can understand – and as anticipated by corporate executives in the insurance industry as well as by those with vested interests in the ADA Department of Dental Informatics – to have to explain to new patients why I cannot estimate how much they will owe for treatment would destroy my practice. Outside the US, other societies deem it unethical to deny patients informed consent to treatment for any reason. The NPI is such an egregious blunder that I never expect those who promoted to accept ownership.

###

NPI

Assessment

If I lost the battle, who won? Do EDR enthusiasts in the ADA call this a glorious victory and a likely source of ADA pride for decades to come? Or is it much more shameful? Since I lost freedom, I want to know who won?

Conclusion

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On the Protecting Access to Healthcare (PATH) Act

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ADA Makes Progress Against McCarran-Ferguson

By D. Kellus Pruitt DDS

The ADA makes real progress against McCarran-Ferguson. I’ve watched the American Dental Association fight long and hard against the unfair McCarran-Ferguson Act of 1945. ADA leaders and I still don’t agree on the need for transparency in the professional organization instead of proud unresponsiveness, but nevertheless, I’ve always been publicly supportive of their efforts to repeal the M-F Act.

Insurance Industry

The insurance industry is powerful in Washington. Over the short term, common sense has proven to be far less influential than their generous campaign contributions – making this a long haul for ADA officials. Yet the amendment to H.R. 5, Protecting Access to Healthcare (PATH) Act, which was offered by Rep. Paul Gosar (R-Ariz.), a dentist, is finally scheduled to come up for a vote on Thursday, March 22, 2012

Good Work – ADA

http://www.ada.org/news/6926.aspx

If passed, the legislation will restore the application of antitrust laws to the business of health insurance. Makes sense, right? After all, if every other business in the nation, including professional organizations, can be prosecuted by the FTC for collusion, why should Delta Dental, BCBSTX and other members of the National Association of Dental Plans (NADP) be exempt from antitrust laws which protect their clients.

I and others are hopeful that this will end many of dental insurers’ current business practices which unfairly force dentists to accept take it or leave it terms that would be unacceptable in a fair market. Maybe the repeal will also make insurance lawyers think twice before alerting the FTC when ADA News speaks honestly about the harm caused by suspiciously similar policies of numerous NADP members.

Assessment

Even if the M-F is repealed, here is an example of truth in dental care that I bet ADA leaders still won’t be able to share with Americans: Unfair downward pressure on contracted dentists’ payments always hurts clueless dental patients the most. Delta Dental’s greed will never be satisfied and dentists’ ethics aren’t free.

NADP, meet the FTC.

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How Physicians Select Risk Management Advisors

More Difficult than Ever Before

By Brian J. Knabe MD, Certified Medical Planner

www.SavantCapital.com

Historically, the term “risk management” has brought to mind one subject for the practicing physician – medical malpractice.  Unfortunately, physicians today face a multitude of other risks which may be more insidious and daunting than malpractice.  It is important to recognize these risks, and to have the appropriate procedures and policies in place to mitigate the risks.  These risks come from the federal government, state government, insurance companies, patients, employees, and even prospective employees.  Some risks, many unique to small businesses and medical practices, include the following:

  • Medicare recoupment risk – challenges to coding and subsequent billing by the physician.
  • Medicare fraud.  Numerous laws can be used by the federal government to go after the physician, including the Medicare and Medicaid Anti-Fraud and Abuse Statute, the RICO statute, and the Federal False Claims Act.  The recently enacted Patient Protection & Affordable Care Act aims to save money by increasing funding for anti-fraud efforts.
  • Insurance fraud.  An inquiry from Medicare to look for fraud in a physician’s practice is often followed by similar efforts by insurance companies.
  • The HIPPA Act of 1996 creates new definitions and penalties to use against the physician.
  • Self referral risks.  Federal regulations in this area include the Medicare Anti-Fraud and Abuse Statute, the Medicare Safe Harbor Regulations, and the Stark Amendment.
  • Federal agency risks.  These include regulations from the Occupational Health and Safety Agency (OSHA), Health and Human Services (HHS), the Drug Enforcement agency (DEA), and even the Environmental Protection Agency (EPA).
  • Anti-trust risks.  The Department of Justice (DOJ) and Federal Trade Commission (FTC) formulate regulations in this arena.
  • Managed care contractual risks.  Most managed care contracts require the individual physician rather than the professional corporation to sign the contract, thus placing the physician’s personal assets at risk.
  • Medical malpractice risks.  Although the vast majority of claims are paid by the insurance carrier, there can be other adverse consequences for the physician.  These include the risk of increased premiums, non-renewal of policies, and difficulty in getting replacement insurance.
  • Loss of income due to death or disability.  Most physicians recognize the importance of life insurance, but the medical professional is actually much more likely to lose income due to disability at some point in his or her career.

http://www.amazon.com/Insurance-Management-Strategies-Physicians-Advisors/dp/0763733423/ref=sr_1_6?ie=UTF8&qid=1375149801&sr=8-6&keywords=marcinko+david

The practicing physician should seek the advice of professionals with expertise in these areas.  Every practice should have an experienced attorney on retainer.  It is very important to seek advice from fiduciaries – experts who have no conflicts of interest and who can therefore act in the best interest of the client.  A Certified Medical Planner is such a fiduciary with training and expertise in these areas.

http://www.CertifiedMedicalPlanner.org

It can be particularly challenging to find an insurance advisor with no conflicts of interest, as this industry is built upon product sales and commissions.  One such insurance advisor is Scott Witt, a fee-only insurance advisor with Witt Actuarial Services (www.wittactuarialservices.com).

Others can be found with an internet search for “fee only insurance advisor”.

Assessment

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Queries for the ADA Member Service Center

Four Questions for Consideration

[By Darrell K. Pruitt; DDS]

Dear ME-P Readers

I’m considering these four questions for the ADA Member Service Center to break the ice. What do you think?

Question 1 – The FTC’s Red Flags Rule is due to be enforced on June 10. If the Rule is not delayed for a fifth time and a dentist has a contractual relationship with CareCredit/GE or similar healthcare financing service, will that mean he or she will become a covered entity obligated to additional paperwork, liability and expense?

Question 2 – According to the “ADA National Oral Health Agenda” found on the Advocacy page, it states that one of the ways the ADA intends to reduce the cost of dental care is to promote health information technology. This goal was first posted several years ago. Considering the ever increasing liability of data breaches in healthcare, can consumers still expect to save money in dental care by visiting a paperless practice?

Question 3 – Am I correct to assume that soon the ADA.org Website will include the capability for direct discussions between members and leadership?

Question 4 – If interactive functions are indeed to be included in the new ADA Website, will there be any topics concerning ADA policy that will be closed to questions from membership?

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Editors Note: The incredible power of the internet is illustrated with this post relative to the phenomenon of “crowd-sourcing.” In this context, the term means to harvest the reach of social networking, like this ME-P, to solve a problem, or ask for input or opinions.

IOW: A knowledge seeker asks a question and participants respond.  PeerClip.com is an example of how “wisdom of the crowds” allows you to follow the latest opinions on interesting topics. In the medical practice management arena, you can also participate at the: www.BusinessofMedicalPractice.com, our newest 850 page book available this Fall.

Channel Surfing the ME-P Have you visited our other topic channels? Established to facilitate idea exchange and link our community together, the value of these topics is dependent upon your input. Please take a minute to visit. And, to prevent that annoying spam, we ask that you register. It is fast, free and secure.

Conclusion

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